Lilly’s Foundayo (orforglipron), the only oral GLP-1 taken without food or water restrictions, was associated with significant weight loss in women at every stage of menopause

PR Newswire

In ATTAIN-1, women in perimenopause taking Foundayo lost up to 30.4 lbs (14.4%) and those in post-menopause lost up to 28.2 lbs (14.1%)

In ATTAIN-2, women taking Foundayo lost significant weight across all stages of menopause, despite the additional challenge of living with type 2 diabetes

Across studies, women taking Foundayo saw meaningful reductions in their waist circumference, a measure associated with reduced abdominal fat and cardiometabolic risk

INDIANAPOLIS, June 7, 2026 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY), the maker of Zepbound (tirzepatide), today announced results demonstrating that women with obesity or overweight who took the highest dose of Foundayo experienced significant weight loss at every stage of menopause. These findings, based on post-hoc analyses of more than 1,500 female participants in the ATTAIN-1 and ATTAIN-2 clinical trials, were presented at the American Diabetes Association (ADA) 86th Scientific Sessions.

Menopause is a major, yet often overlooked, driver of weight gain. Hormonal changes during this time can accelerate fat accumulation, particularly around the abdomen, and make weight loss harder to achieve and sustain.1 Despite affecting tens of millions of women in the U.S. alone, menopausal status has rarely been evaluated as a factor in obesity treatment efficacy.2

“Menopause can be an incredibly frustrating time for many women, partly because weight gain often feels beyond their control, and the biology of menopause can undermine even the most determined efforts to manage weight,” said Rachel Batterham, OBE, MBBS, Ph.D., FRCP, Lilly senior vice president of medical innovation and external engagement. “These findings show that Foundayo was associated with meaningful weight loss in women at every stage of menopause. For women who have seen their weight become harder to manage precisely when their health is more at risk, this is what progress could look like.”

Across ATTAIN‑1 and ATTAIN‑2, Foundayo was associated with significant reductions in body weight at 72 weeks across menopausal stages. In ATTAIN‑1, women who were pre‑, peri‑ and post‑menopausal lost up to 28.0 lbs (12.8%), 30.4 lbs (14.4%) and 28.2 lbs (14.1%) respectively on the highest dose of Foundayo. In ATTAIN‑2, women with type 2 diabetes who were pre‑, peri‑ and post‑menopausal lost up to 23.4 lbs (11.3%), 18.5 lbs (8.9%) and 27.8 lbs (13.6%) respectively. At the highest dose, up to 51.5% of women in ATTAIN-1 and up to 44.2% in ATTAIN-2 experienced ≥15% weight loss. Women also experienced meaningful reductions in waist circumference, with decreases of up to 4.9 inches (12.5 cm) in ATTAIN‑1 and up to 4.3 inches (11.0 cm) in ATTAIN‑2 at 72 weeks.

ATTAIN-1 and ATTAIN-2 Post-Hoc Analyses: Key Results with Foundayo 17.2 mg


ATTAIN-1


Pre-menopause


(n=171)


Perimenopause


(n=142)


Post-menopause


(n=152)

Baseline body weight

219.1 lbs (99.4 kg)

217.6 lbs (98.7 kg)

208.6 lbs (94.6 kg)

Change in body weight from baseline

-12.8%

 

(-28.0 lbs; -12.7 kg)

-14.4%

 

(-30.4 lbs; -13.8 kg)

-14.1%

 

(-28.2 lbs; -12.8 kg)

Percent of participants achieving ≥5% weight loss

80.3 %

80.9 %

82.7 %

Percent of participants achieving ≥10% weight loss 

61.5 %

64.2 %

64.1 %

Percent of participants achieving ≥15% weight loss

40.9 %

51.5 %

45.4 %

Percent of participants achieving ≥20% weight loss

24.2 %

29.9 %

23.8 %

Change in waist circumference from baseline

-4.5 in (-11.4 cm)

-4.9 in (-12.5 cm)

-4.8 in (-12.3 cm)


ATTAIN-2


Pre-menopause


(n=10)


Perimenopause


(n=33)


Post-menopause


(n=109)

Baseline body weight

237.9 lbs (107.9 kg)

209.7 lbs (95.1 kg)

202.2 lbs (91.7 kg)

Change in body weight from baseline

-11.3%

 

(-23.4 lbs; -10.6 kg)

-8.9%

 

(-18.5 lbs; -8.4 kg)

-13.6%

 

(-27.8 lbs; -12.6 kg)

Percent of participants achieving ≥5% weight loss

79.5 %

67.1 %

81.6 %

Percent of participants achieving ≥10% weight loss

52.5 %

39.5 %

68.0 %

Percent of participants achieving ≥15% weight loss

36.4 %

20.4 %

44.2 %

Percent of participants achieving ≥20% weight loss

32.1 %

9.7 %

21.7 %

Change in waist circumference from baseline

-4.3 in (-11.0 cm)

-3.3 in (-8.4 cm)

-4.3 in (-11.0 cm)

About Foundayo

Foundayo (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake. Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, orforglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.

About ATTAIN-1, ATTAIN-2 and ATTAIN clinical trial program 
ATTAIN-1 (NCT05869903) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Foundayo 5.5 mg, 9 mg and 17.2 mg as a monotherapy to placebo in adults with obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease, who did not have diabetes. The trial is the first Phase 3 study of this patient population in which treatment was evaluated as an adjunct to exercise and a balanced, healthy diet rather than a reduced-calorie diet. The trial randomized 3,127 participants across the U.S., Brazil, China, India, Japan, South Korea, Puerto Rico, Slovakia, Spain and Taiwan in 3:3:3:4 ratio to receive either 5.5 mg, 9 mg or 17.2 mg Foundayo or placebo. The primary objective of the study was to demonstrate that Foundayo (5.5 mg, 9 mg or 17.2 mg) is superior to placebo in body weight reduction from baseline after 72 weeks in people with a BMI ≥30.0 kg/m² or a BMI ≥27.0 kg/m² with at least one weight-related comorbidity and a history of at least one self-reported unsuccessful dietary effort to lose body weight.

ATTAIN-2 (NCT05872620) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Foundayo 5.5 mg, 9 mg or 17.2 mg as monotherapy with placebo in adults with obesity or overweight and type 2 diabetes. The trial randomized over 1,600 participants across the U.S., Argentina, Australia, Brazil, China, Czechia, Germany, Greece, India, South Korea and Puerto Rico in a 1:1:1:2 ratio to receive either 5.5 mg, 9 mg or 17.2 mg Foundayo or placebo. The primary objective of the study was to demonstrate that Foundayo (5.5 mg, 9 mg or 17.2 mg) is superior to placebo in mean body weight change from baseline at 72 weeks in people with a BMI ≥27.0 kg/m² and type 2 diabetes who are on stable treatment with either diet/exercise alone or up to three oral antihyperglycemic medications.

In both trials, all participants in the Foundayo treatment arms started the study at a dose of Foundayo 0.8 mg once-daily and then increased the dose in a step-wise approach at four-week intervals to their final randomized maintenance dose of 5.5 mg (via steps at 0.8 mg and 2.5 mg), 9 mg (via steps at 0.8 mg, 2.5 mg and 5.5 mg) or 17.2 mg (via steps at 0.8 mg, 2.5 mg, 5.5 mg, 9 mg and 14.5 mg). These trials were conducted using an investigational formulation of Foundayo at dosages equivalent to Foundayo tablets.

Endnotes and References

  1. Kapoor E, Collazo-Clavell ML, Faubion SS. Weight gain in women at midlife: a concise review. J Clin Endocrinol Metab. 2017;102(10):3732-3741.
  2. North American Menopause Society. The 2023 position statement of The North American Menopause Society. Menopause. 2023;30(4):573-590.

INDICATION AND SAFETY SUMMARY WITH WARNINGS

Foundayo (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.

  • Foundayo should not be used with other GLP-1 receptor agonist medicines.
  • It is not known if Foundayo is safe and effective for use in children.

Warnings – Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

  • Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
  • Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo.

Foundayo may cause serious side effects, including:

Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery.

Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo.

Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures.

Common side effects

The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before taking Foundayo

  • Tell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works.
  • Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).
  • If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo.
  • Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.

Review these questions with your healthcare provider:

❑ Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby.
❑ Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo.
❑ Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements?

How to take

  • Take Foundayo exactly as your healthcare provider tells you to.
  • Use Foundayo with a reduced-calorie diet and increased physical activity.
  • Take Foundayo by mouth 1 time each day, with or without food.
  • Swallow tablets whole. Do not break, crush, or chew the tablet.
  • If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day.
  • Do not take more than 1 tablet per day.
  • If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment.
  • If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Learn more

Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com.

This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you.

OG CON BS APR2026

ZEPBOUND INDICATIONS AND SAFETY SUMMARY WITH WARNINGS

Zepbound (ZEHP-bownd) is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with:

  • obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.
  • moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA.

Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children.

Warnings – Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

  • Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
  • Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.

KwikPen: Do not share your KwikPen with other people, even if the pen needle has been changed. You may give other people a serious infection or get a serious infection from them.

Zepbound may cause serious side effects, including:

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.

Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back.

Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.

Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound.

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures.

Common side effects

The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using Zepbound

  • Your healthcare provider should show you how to use Zepbound before you use it for the first time.
  • Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.
  • If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound.

Review these questions with your healthcare provider:

❑ Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ Do you take diabetes medicines, such as insulin or sulfonylureas?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound   may harm your unborn baby. Tell your healthcare provider if you become pregnant while using  Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound.

  • Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Lilly at 1-800-LillyRx (1-800-545-5979).

How to take

  • Read the Instructions for Use that come with Zepbound.
  • Use Zepbound exactly as your healthcare provider says.
  • Use Zepbound with a reduced-calorie diet and increased physical activity.
  • Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or have another person inject in the back of the upper arm. Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously).
  • Use Zepbound 1 time each week, at any time of the day.
  • Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.

If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Zepbound is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection.

Learn more
Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to www.zepbound.lilly.com.

This summary provides basic information about Zepbound but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you.

ZP CON BS 25FEB2026

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We’ve been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world’s most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer’s disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we’re motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Foundayo (orforglipron) as a potential treatment for adults with obesity and the timeline for future readouts, presentations, and other milestones relating to Foundayo and its clinical trials, and reflects Lilly’s current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that Foundayo will receive additional regulatory approvals, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly’s expectations, see Lilly’s Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company’s or their rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.


Refer to:     

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RGC Deadline: RGC Investors with Losses in Excess of $100K Have Opportunity to Lead Regencell Bioscience Holdings Limited Securities Fraud Lawsuit

PR Newswire

NEW YORK, June 7, 2026 /PRNewswire/ —

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Why: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Regencell Bioscience Holdings Limited (NASDAQ: RGC) between October 28, 2024 and October 31, 2025, inclusive (the “Class Period”), of the important June 23, 2026 lead plaintiff deadline.

So what: If you purchased Regencell securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

What to do next: To join the Regencell class action, go to https://rosenlegal.com/submit-form/?case_id=62621 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than June 23, 2026. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

Why Rosen Law: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved, at that time, the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

Details Of The Case: According to the lawsuit, throughout the Class Period, defendants made false and/or misleading statements and/or failed to disclose that: (1) Regencell was vulnerable and/or subject to market manipulation; (2) the resulting volatility in the market for Regencell’s ordinary shares exposed Regencell investors to significant financial risk; (3) all the foregoing subjected Regencell to a heightened risk of regulatory and/or governmental scrutiny and enforcement action, as well as significant legal, monetary, and reputational harm; and (4) as a result, defendants’ public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages. 

To join the Regencell class action, go to https://rosenlegal.com/submit-form/?case_id=62621 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

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Contact Information:

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SRAD Investors Have Opportunity to Lead Sportradar Group AG Securities Fraud Lawsuit

PR Newswire

NEW YORK, June 6, 2026 /PRNewswire/ — 

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Why: Rosen Law Firm, a global investor rights law firm, reminds purchasers of Class A ordinary shares of Sportradar Group AG (NASDAQ: SRAD) between November 7, 2024 and April 21, 2026, inclusive (the “Class Period”), of the important July 17, 2026 lead plaintiff deadline.

So what: If you purchased Sportradar Class A ordinary shares during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

What to do next: To join the Sportradar class action, go to https://rosenlegal.com/cases/sportradar-group-ag/join or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than July 17, 2026. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

Why Rosen Law: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually handle securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved, at that time, the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

Details of the case: According to the lawsuit, throughout the Class Period, defendants made false and/or misleading statements and/or failed to disclose that: (1) Sportradar intentionally worked with black-market gambling operators to increase its revenues, despite its assurances of strict legal and regulatory compliance and claims that ethics and integrity were crucial for Sportradar’s operations; (2) Sportradar’s Know-Your-Customer (“KYC”) and compliance processes were not as robust as defendants’ had claimed; and (3) as a result, defendants’ statements about Sportradar’s business, operations, and prospects lacked a reasonable basis. When the true details entered the market, the lawsuit claims that investors suffered damages. 

To join the Sportradar class action, go to https://rosenlegal.com/cases/sportradar-group-ag/join or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

Contact Information:

     Laurence Rosen, Esq.
     Phillip Kim, Esq.
     The Rosen Law Firm, P.A.
     275 Madison Avenue, 40th Floor
     New York, NY 10016
     Tel: (212) 686-1060
     Toll Free: (866) 767-3653
     Fax: (212) 202-3827
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SOURCE THE ROSEN LAW FIRM, P. A.

WGS Investors Have Opportunity to Lead GeneDx Holdings Corp. Securities Fraud Lawsuit

PR Newswire

NEW YORK, June 6, 2026 /PRNewswire/ —

Rosen Law Firm Logo

Why: Rosen Law Firm, a global investor rights law firm, announces a class action lawsuit on behalf of purchasers of common stock of GeneDx Holdings Corp. (NASDAQ: WGS) between April 16, 2025 and May 4, 2026, inclusive (the “Class Period”). A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than August 3, 2026.

So What: If you purchased GeneDx common stock during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

What to do next: To join the GeneDx class action, go to https://www.rosenlegal.com/cases/genedx-holdings-corp/join or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than August 3, 2026. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

Why Rosen Law: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved, at that time, the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

Details of the case: According to the lawsuit, the claims against defendants arise from their misrepresentations and omissions regarding GeneDx’s statements regarding the impact of Fabric on the overall business of GeneDx. Throughout the Class Period, GeneDx repeatedly made statements that would have caused the average investor to believe that the Fabric acquisition would improve GeneDx’s financials and create efficiencies between it and GeneDx’s core business. These statements include such statements such as: “There is room to run in terms of reducing COGS in the future by combining the best of capability between GeneDx and Fabric as we lean into the best possible algorithms to optimize dry lab processes.” These and similar statements made throughout the Class Period were false. In truth, defendants knew of, or recklessly disregarded, significant problems in Fabric’s viability that would negatively impact GeneDx’s overall business and operations. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the GeneDx class action, go to https://www.rosenlegal.com/cases/genedx-holdings-corp/join or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

Contact Information:

Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
[email protected]
www.rosenlegal.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/wgs-investors-have-opportunity-to-lead-genedx-holdings-corp-securities-fraud-lawsuit-302793132.html

SOURCE THE ROSEN LAW FIRM, P. A.

Real-World Evidence of Eversense 365 Presented at ADA Demonstrating Strong Performance and Patient Impact in Both Open and Closed Loop Systems

Eversense 365 delivered favorable glucometrics compared to other open and closed loop systems, validating the one-year CGM’s differentiated approach and high performance 

New data expands on findings shared at ATTD and reinforces Eversense 365’s strong patient adherence, glucometrics and hypoglycemic outcomes across an entire year

GERMANTOWN, Md., June 06, 2026 (GLOBE NEWSWIRE) — Senseonics Holdings, Inc. (NASDAQ: SENS), a medical technology company focused on the development, manufacturing and commercialization of long-term, implantable Continuous Glucose Monitoring (CGM) Systems for people with diabetes, today announces further data from a large real-world evidence study which reveals sustained accuracy, performance and positive impact of Eversense 365 in both open-loop and closed-loop systems. The findings were presented during an oral presentation entitled ‘Real-World Evaluation of the Implantable One-Year Eversense 365 CGM System’ at the American Diabetes Association’s (ADA) 2026 Scientific Sessions, taking place on June 5-8 in New Orleans, U.S.   

The data presented at ADA expands on the findings Senseonics previously shared at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) earlier this year, with a dataset including more sensors and users of Eversense 365, the first and only one year CGM- system. The presentation highlighted a real-world analysis of the first 12,360 Eversense 365 CGM sensors among open-loop users and an additional 153 closed-loop users, with the CGM used as part of the twiist™ Automated Insulin Delivery (AID) system for more than 30 days.

The extended dataset confirms the positive real-world impact of Eversense 365, with a full year of strong patient adherence, glucometrics and hypoglycemic outcomes. Importantly, the system delivered comparable adherence and outcomes between the first and second six-month period, indicating high accuracy and performance from a single sensor across an entire year. The presentation also highlighted strong glucometrics of the Eversense 365 and twiist combination, suggesting that the first ever AID integration with this unique CGM is having a meaningful clinical impact for people living with diabetes.  

“This real-world data showcases the positive impact that Eversense 365 is bringing to patients, regardless of their preferred treatment plan,”

said Francine Kaufman, M.D., Chief Medical Office at Senseonics.

“The analysis shows Eversense 365 is delivering consistent and tangible benefits for people on either an open or closed loop system, giving patients and healthcare providers more choice and more confidence when using our differentiated CGM. This is vital because everyone’s experience with diabetes is different. Eversense 365 performs exceptionally well over an extended period and data suggests its use with twiist was favorable compared to what has been reported for other AID systems in real world settings. We look forward to reporting more real-world evidence on Eversense and the AID combination as our userbase expands.”


Brian Hansen, Chief Commercial Officer at Senseonics, added:

“We’re delighted to be able to share this new data and our additional findings with the diabetes community at ADA. The fact that a single CGM sensor can deliver consistent performance across the first half and second half of a full year is outstanding. It validates the technology we have on the market today, in Eversense 365, and it validates our exciting product pipeline that is based on the same fundamental science. There is nothing more powerful than real-world evidence and this, alongside excellent anecdotal feedback, is galvanizing the Senseonics team as commercial momentum continues to grow.”

As the only implantable CGM available, Eversense 365 offers patients a truly differentiated CGM experience, providing one year of exceptionally accurate monitoring with minimal interruptions. Eversense 365’s unique approach allows people to overcome common frustrations and interruptions experienced with traditional, short-term CGMs, so that patients can focus on managing their diabetes and not their CGM.


Strong adherence and positive outcomes in open loop insulin regimens across all age groups


The larger dataset bolsters the previous findings presented at ATTD which underscored Eversense 365’s strong patient adherence, glucometrics and hypoglycemic outcomes. These findings, when combined with the previous analysis, reinforce that Eversense 365 can support the effective management of diabetes over a full one-year period with just one implantable CGM sensor.

Positive outcomes and engagement with Eversense 365 were seen across all age groups, with an average transmitter wear time of 93.19% across 12,360 sensors. Analysis showed comparable results across wear time, glucometrics and hypoglycemic outcomes for the first and second six-month periods, reinforcing consistent and meaningful system use across the entire sensor lifetime. On average, users had a mean Glucose Management Indicator (GMI)1 of 7.16% and a mean Time In Range (TIR) of 66.16%, metrics which represent effective glycemic control. This also means that Eversense 365 delivered favorable glycemic outcomes compared to real-world reports on open-loop insulin regimens using other CGM systems, which reported TIR varying from 41.7-70.8%.2,3,4,5

Furthermore, more than 81% of Eversense 365 users achieved hypoglycemic targets6. This compares favorably to other CGM systems and reinforces Eversense 365’s accuracy in low glucose ranges7,8,9, where errors can have the greatest impact on patient safety and treatment decisions.


Strong initial performance from Eversense 365 and twiist AID system integration


Building on the earlier findings shared at ATTD, this analysis included an additional 153 sensors that had been used in combination with the twiist AID system for more than 30 days. This expanded and extended analysis highlights the strong performance of Eversense 365 as part of an AID system to date and suggests that the combination is already demonstrating a positive and meaningful clinical impact for people living with diabetes.

The data shows that people using the twiist AID system with Eversense 365 had a mean TIR of approximately 76.08% and a GMI of 6.78% after the first 30 days following pump pairing. When compared to large real-world datasets of existing AID systems, the Eversense 365 integration is at the top end of reported performance ranges for TIR (approximately 52.5-78.8%) and GMI (6.9-7.9%), depending on system use patterns.10,11,12

Eversense 365 and twiist integration users also had very strong adherence with a median sensor wear time of 99.46%. As expected, when compared to a baseline of Eversense 365 users on an open-loop regimen, those using the sensor with a closed loop system have improved glucometrics. Whilst these findings are still early stage, they strongly suggest that the combination of Eversense 365 and twiist helps people achieve glycemic targets and improve their diabetes management.

About Eversense

Eversense 365 is developed by Senseonics and, as the only implantable CGM available, offers patients a truly differentiated CGM experience, providing One Year of exceptionally accurate monitoring with minimal interruptions. It benefits endocrinologists and care teams by offering their patients confidence in decision making, long-term peace of mind and enhanced quality of life with just one CGM. The unique approach also allows people to overcome common frustrations and interruptions experienced with traditional, short-term CGMs, so that patients can focus on managing their diabetes and not their CGM.

The Eversense® Continuous Glucose Monitoring (CGM) Systems are indicated for continually measuring glucose levels for up to 365 days for Eversense® 365 and 180 days for Eversense® E3 in persons with diabetes age 18 and older. The systems are indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration primarily one time per week after day 14 for Eversense® 365 and one time per day after day 21 for Eversense® E3, and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a health care provider. The Eversense CGM Systems are prescription devices; patients should talk to their health care provider to learn more. For important safety information, see https://www.eversensediabetes.com/safety-info/.

About Senseonics

Senseonics Holdings, Inc. (“Senseonics”) is a medical technology company focused on the development, manufacturing and commercialization of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics’ CGM system Eversense® 365 and Eversense® E3 include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user’s smartphone.

Senseonics Media Contact

Tim Stamper
FTI Consulting
[email protected] / [email protected]

Senseonics Investor Contact

Jeremy Feffer
LifeSci Advisors
[email protected] 



1

GMI is an established metric that provides an estimated A1C using only CGM data, with a lower value indicating better management and reduced health risks. GMI is often used alongside TIR to provide a more complete picture of glycemic control.


2

Layne JE, Jepson LH, Carite AM, Parkin CG, Bergenstal RM. Long-Term Improvements in Glycemic Control with Dexcom CGM Use in Adults with Noninsulin-Treated Type 2 Diabetes. Diabetes Technol Ther. 2024 Dec;26(12):925–31. doi:10.1089/dia.2024.0197 PubMed PMID: 38904213.


3

Dowd R, Jepson LH, Green CR, Norman GJ, Thomas R, Leone K. Glycemic Outcomes and Feature Set Engagement Among Real-Time Continuous Glucose Monitoring Users With Type 1 or Non–Insulin-Treated Type 2 Diabetes: Retrospective Analysis of Real-World Data. JMIR Diabetes. 2023 Jan 18;8:e43991. doi:10.2196/43991 PubMed PMID: 36602920; PubMed Central PMCID: PMC9947825.

4
Choudhary P, Kao K, Dunn TC, Brandner L, Rayman G, Wilmot EG. Glycaemic measures for 8914 adult FreeStyle Libre users during routine care, segmented by age group and observed changes during the COVID-19 pandemic. Diabetes Obes Metab. 2022 Oct;24(10):1976–82. doi:10.1111/dom.14782 PubMed PMID: 35638378; PubMed Central PMCID: PMC9347804.

5
Medtronic News [Internet]. [cited 2026 Apr 20]. Real-World Data from Guardian(TM) Connect and Sugar.IQ(TM) Reveal Improved Diabetes Outcomes. Available from: https://news.medtronic.com/2019-06-10-Real-World-Data-from-Guardian-TM-Connect-and-Sugar-IQ-TM-Reveal-Improved-Diabetes-Outcomes

6 Battelino T, Danne T, Bergenstal RM, et al. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019;42(8):1593-1603. doi:10.2337/dci19-0028
7 Senseonics. (2026) Eversense 365 Continuous Glucose Monitoring System User Guide. LBL-7702-01-001
8 Abbott. (2024) Freestyle Libre 3 PLUS User Guide ART49385-001
9 Dexcom (2025) G7 15 Day User Guide AW00078-10 MT-00078-10
10 Choudhary P, Arrieta A, van den Heuvel T, Castañeda J, Smaniotto V, Cohen O. Celebrating the Data from 100,000 Real-World Users of the MiniMedTM 780G System in Europe, Middle East, and Africa Collected Over 3 Years: From Data to Clinical Evidence. Diabetes Technol Ther. 2024 Mar;26(S3):32–7. doi:10.1089/dia.2023.0433 PubMed PMID: 38377326; PubMed Central PMCID: PMC10890936.
11 Forlenza GP, DeSalvo DJ, Aleppo G, Wilmot EG, Berget C, Huyett LM, et al. Real-World Evidence of Omnipod® 5 Automated Insulin Delivery System Use in 69,902 People with Type 1 Diabetes. Diabetes Technol Ther. 2024 Aug;26(8):514–25. doi:10.1089/dia.2023.0578 PubMed PMID: 38375861.
12 Breton MD, Kovatchev BP. One Year Real-World Use of the Control-IQ Advanced Hybrid Closed-Loop Technology. Diabetes Technol Ther. 2021 Sep;23(9):601–8. doi:10.1089/dia.2021.0097 PubMed PMID: 33784196; PubMed Central PMCID: PMC8501470.



Corcept Presents New Data at ADA:Improved Outcomes in Patients Receiving a GLP-1 with Difficult-to-Control Type 2 Diabetes and Hypercortisolism Treated with Korlym®

Corcept Presents New Data at ADA:Improved Outcomes in Patients Receiving a GLP-1 with Difficult-to-Control Type 2 Diabetes and Hypercortisolism Treated with Korlym®

  • New data from CATALYST and MOMENTUM trials presented at American Diabetes Association’s (ADA) 86th Scientific Sessions

  • In the CATALYST trial, patients with hypercortisolism treated with Korlym exhibited clinically and statistically significant improvements in hemoglobin A1c (HbA1c) and clinically meaningful reductions in body weight, body mass index and waist circumference, with numerically greater benefit in those taking GLP-1 receptor agonists or tirzepatide

  • Late-breaking data from the MOMENTUM trial confirm high prevalence of endogenous hypercortisolism in patients with type 2 diabetes and resistant hypertension

REDWOOD CITY, Calif.–(BUSINESS WIRE)–
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced the presentation of new data from its CATALYST and MOMENTUM trials at the American Diabetes Association’s 86th Scientific Sessions. The presentations underscore the critical role of hypercortisolism in difficult-to-control type 2 diabetes and resistant hypertension, and the potential of cortisol modulation treatment.

The CATALYST trial screened 1,057 patients with difficult-to-control type 2 diabetes (HbA1c of 7.5 – 11.5 percent despite receiving multiple glucose-lowering medications) and found that 24 percent had hypercortisolism (cortisol levels of greater than 1.8 μg/dL in the 1 mg dexamethasone suppression test (DST)). In CATALYST’s treatment phase, 136 of the patients who had been found to have hypercortisolism were randomized 2:1 to receive either Korlym or placebo for 24 weeks. Patients who received Korlym exhibited a clinically meaningful and statistically significant reduction in HbA1c (1.3 percent, p-value: <0.001). These patients also exhibited clinically meaningful reductions in body weight (5.1 kg), body mass index (1.7 kg/m2) and waist circumference (5.1 cm), compared to patients who received placebo (all nominal p-values less than 0.002). These findings were published in Diabetes Care in June 2025. The most common adverse events (>10 percent) were hypokalemia, fatigue, nausea, vomiting, headache, peripheral edema, diarrhea and dizziness.

The data presented at ADA described treatment outcomes in the 71 patients in CATALYST who were taking GLP-1 receptor agonists or the GLP-1/GIP agonist tirzepatide. In this group, patients who received Korlym exhibited numerically greater benefit than the overall study population with reductions in HbA1c (1.7 percent), body weight (6.1 kg), body mass index (2.0 kg/m2) and waist circumference (6.5 cm), compared to patients who received placebo (all nominal p-values less than 0.04).

“These new CATALYST data demonstrate the potential of cortisol modulation to improve critical metabolic parameters, even for patients who have poorly controlled type 2 diabetes despite treatment with powerful GLP-1 or GLP-1/GIP receptor agonists, such as semaglutide or tirzepatide. Excess cortisol disrupts the incretin system, impairs beta cell function, and induces insulin and incretin resistance, potentially limiting the effectiveness of these otherwise potent therapies. Screening for hypercortisolism and considering cortisol-directed treatment is a key part of managing type 2 diabetes in patients not responding to standard-of-care treatments,” said Lance Sloan, M.D., President, Texas Institute for Kidney and Endocrine Disorders.

At ADA, Corcept also presented late-breaking data from its MOMENTUM trial, which screened 1,086 patients with resistant hypertension (as defined by the American Heart Association’s criteria) and found that 27.3 percent of them had hypercortisolism. The prevalence of hypercortisolism was even higher in patients who had hemoglobin A1c (HbA1c) of 7.5 percent or higher and were taking 3 or more blood pressure medicines: 36.6 percent in CATALYST and 32.6 percent in MOMENTUM.

“Data consistently show that hypercortisolism is an underlying driver of treatment resistant cardiometabolic disease, including in patients receiving best-in-class therapies like GLP-1s,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Data from CATALYST demonstrate that treatment with a cortisol modulator, such as Korlym, can be synergistic with GLP-1s or tirzepatide to help patients better control type 2 diabetes. It is our hope that this new research will lead to increased screening for hypercortisolism and improved treatment.”

About CATALYST

CATALYST is the largest and most rigorous trial ever conducted to determine the prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes and assess the effect of treating patients found to have hypercortisolism with a cortisol modulator. The initial prevalence phase of the trial screened 1,057 patients with difficult-to-control type 2 diabetes (i.e., patients with HbA1c greater than 7.5 percent despite receiving multiple glucose-lowering medications, including best-in-class therapies such as GLP-1 and GLP-1/GIP agonists) at 36 sites in the United States. Based on results from a standard 1-mg dexamethasone suppression test, 24 percent of the patients screened were found to have hypercortisolism and were eligible to enter the trial’s treatment phase, where they were randomized, 2:1, to receive either Korlym or placebo for 24 weeks. One hundred thirty-six patients enrolled in the treatment phase.

About MOMENTUM

MOMENTUM was the largest trial ever conducted to assess the prevalence of hypercortisolism in patients with resistant hypertension. A total of 1,086 patients were screened at 50 sites in the United States. All patients had resistant hypertension as defined by the American Heart Association’s criteria (systolic blood pressure greater or equal to 130 mmHg despite taking 3 or more blood-pressure lowering medications, including a diuretic, or taking 4 or more blood-pressure lowering medications). Using a simple, standardized 1-mg dexamethasone suppression test (DST), 27 percent of these patients were found to have hypercortisolism.

About Hypercortisolism

Hypercortisolism, also known as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Symptoms vary, but most patients experience one or more of the following manifestations: hypertension, central obesity, elevated blood sugar and difficult-to-control type 2 diabetes, severe fatigue and weak muscles. Irritability, anxiety, depression and cognitive disturbances are common. Hypercortisolism can affect every organ system and can be fatal if not treated effectively. Cardiovascular events are the most common cause of death among patients with hypercortisolism. Recent research shows that endogenous hypercortisolism is more prevalent than previously believed.

INDICATION

KORLYM (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.

Limitations of use: KORLYM should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushing’s syndrome.

IMPORTANT SAFETY INFORMATION

BOXED WARNING:TERMINATION OF PREGNANCY

Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with Korlym and prevented during treatment and for one month after stopping treatment by the use of a nonhormonal medically acceptable method of contraception unless the patient has had a surgical sterilization, in which case no additional contraception is needed. Pregnancy must also be excluded if treatment is interrupted for more than 14 days in females of reproductive potential.

CONTRAINDICATIONS

Pregnancy; patients taking simvastatin or lovastatin and CYP3A substrates with narrow therapeutic ranges; patients receiving systemic corticosteroids for lifesaving purposes; women with a history of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma; patients with known hypersensitivity to mifepristone or to any of the product components.

WARNINGS AND PRECAUTIONS

Adrenal insufficiency: Patients should be closely monitored for signs and symptoms of adrenal insufficiency. See full Prescribing Information for further management instructions.

Hypokalemia: Hypokalemia should be corrected prior to treatment and monitored for during treatment. Measure serum potassium 1-2 weeks after starting or increasing the Korlym dose, and periodically thereafter. Mifepristone-induced hypokalemia should be treated with potassium supplementation based on severity. If hypokalemia persists despite potassium supplementation, consider adding mineralocorticoid antagonists.

Vaginal bleeding and endometrial changes: Women may experience endometrial thickening or unexpected vaginal bleeding. Use with caution if the patient also has a hemorrhagic disorder or is on anticoagulant therapy. Women who experience vaginal bleeding during treatment should be referred to a gynecologist for further evaluation.

QT interval prolongation: Avoid use with QT interval-prolonging drugs, or in patients with potassium channel variants resulting in a long QT interval.

Exacerbation/Deterioration of Conditions Treated with Corticosteroids: For medical conditions in which chronic corticosteroid therapy is lifesaving, Korlym is contraindicated.

Use of strong CYP3A inhibitors: Concomitant use increases mifepristone plasma levels. Use only when necessary and do not exceed a Korlym dose of 900 mg per day.

The labeling contains warnings and precautions forPneumocystis jiroveci Infectionandpotential effects of hypercortisolemia. See full Prescribing Information for further management instructions.

ADVERSE REACTIONS

Most common adverse reactions in Cushing’s syndrome (≥20%): nausea, fatigue, headache, decreased blood potassium, arthralgia, vomiting, peripheral edema, hypertension, dizziness, decreased appetite, and endometrial hypertrophy.

DRUG INTERACTIONS

Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest dose when used with Korlym.

CYP3A inhibitors: Caution should be used when Korlym is used with strong CYP3A inhibitors. Use only when necessary, and do not exceed a Korlym dose of 900 mg.

CYP3A inducers: Do not use Korlym with CYP3A inducers.

Drugs metabolized by CYP2C8/2C9: Use the lowest dose of CYP2C8/2C9 substrates when used with Korlym.

Drugs metabolized by CYP2B6: Use of Korlym should be done with caution with bupropion and efavirenz.

Hormonal contraceptives: Do not use with Korlym.

DOSAGE AND ADMINISTRATION

Obtain a negative pregnancy test prior to initiating treatment with Korlym in females of reproductive potential, or if treatment is interrupted for more than 14 days.

Administer once daily orally with a meal. The recommended starting dose is 300 mg once daily. Renal impairment: Do not exceed 600 mg once daily. Mild-to-moderate hepatic impairment: Do not exceed 600 mg once daily. Do not use in severe hepatic impairment. Based on clinical response and tolerability, the dose may be increased in 300-mg increments to a maximum of 1200 mg once daily. Do not exceed 20 mg/kg per day.

Concomitant use of Korlym with a strong CYP3A inhibitor resulted in a 38% increase in mean plasma concentration of mifepristone. For patients already being treated with a strong CYP3A inhibitor, start with a Korlym dose of 300 mg per day and titrate to a maximum of 900 mg per day if clinically indicated. When a strong CYP3A inhibitor is administered to patients already receiving Korlym, adjust the dose as follows: for patients receiving a daily dose of 600 mg, reduce dose to 300 mg. For patients receiving a daily dose of 900 mg, reduce dose to 600 mg. For patients receiving a daily dose of 1200 mg, reduce dose to 900 mg. Titrate if clinically indicated and do not exceed a Korlym dose of 900 mg in combination with a strong CYP3A inhibitor.

USE IN SPECIFIC POPULATIONS

Lactation: Mifepristone is present in human milk, however, there are no data on the amount of mifepristone in human milk, the effects on the breastfed infant, or the effects on milk production during long term use of mifepristone.

About Corcept Therapeutics

For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with Cushing’s syndrome, solid tumors, ALS and liver disease. In 2012, the company introduced Korlym®, the first medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with endogenous Cushing’s syndrome, and in 2026, the company introduced Lifyorli™, approved in combination with nab-paclitaxel, the first FDA-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com.

Forward-Looking Statements

Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from any future results expressed or implied by such forward-looking statements.

In this press release, forward-looking statements include statements concerning: the potential for cortisol modulation treatment to improve critical metabolic parameters, even for patients with poorly controlled type 2 diabetes despite treatment with powerful GLP-1 or GLP-1/GIP receptor agonists; and our hope that the findings from the CATALYST and MOMENTUM trials will lead to increased screening for hypercortisolism and improved treatment.

A further description of risks and uncertainties can be found in our SEC filings, which are available at our website and the SEC’s website. These risks and uncertainties include, but are not limited to, those related to: our ability to operate our business; our efforts to study and develop Korlym, relacorilant, miricorilant, dazucorilant, nenocorilant and our other product candidates; those molecules’ clinical attributes; regulatory approvals, mandates, oversight and other requirements imposed on our products or our business by laws, regulations or discretion of government authorities; and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.

Investor inquiries:

[email protected]

Media inquiries:

[email protected]

www.corcept.com

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Research Diabetes Clinical Trials Biotechnology Health Pharmaceutical General Health Science Oncology

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Dexcom CONNECT Study: The Most Significant Clinical Study Demonstrating CGM Benefits for People with Type 2 Diabetes Not Using Insulin

Dexcom CONNECT Study: The Most Significant Clinical Study Demonstrating CGM Benefits for People with Type 2 Diabetes Not Using Insulin

  • Dexcom sponsored CONNECT randomized controlled trial expected to help establish new standard of care for CGM use by people with Type 2 diabetes not using insulin around the world.
  • Showed use of Dexcom G7 led to clinically and statistically significant reduction in HbA1c and improvement in quality of glucose control, including time in range and level 1 and 2 hyperglycemia.1
  • Demonstrated additional clinically significant improvement in A1C reduction across study participants using Dexcom G7 in combination with various diabetes medications, including metformin, GLP-1s and SGLT2s.1

SAN DIEGO–(BUSINESS WIRE)–DexCom, Inc. (NASDAQ:DXCM) announced today results from the CONNECT randomized controlled trial, demonstrating the use of Dexcom G7 leads to clinically and statistically significant reduction in A1C and improvement in glucose control among people with Type 2 diabetes not using insulin compared with a routine care control group using self-monitoring of blood glucose.1 Researchers presented these results today as an oral presentation at the 2026 Scientific Sessions of the American Diabetes Association in New Orleans.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260606323066/en/

“The CONNECT study released today is the first and only level A evidence demonstrating strong benefit of CGM for the Type 2 non-insulin using population,” said Roy Beck, MD, PhD, medical director of the JAEB Center for Health Research and senior author of the study. “Level A evidence, the highest level of evidence graded by the ADA, has historically driven meaningful changes in standards of care.”

CONNECT demonstrated clinically significant benefit for all adult Type 2 non-insulin using patients regardless of age, gender, ethnicity, baseline A1C, body mass index, education level, income and insurance coverage.1 The study also showed an additional clinically significant reduction in A1C when using Dexcom G7 with various combinations of current standards of care diabetes medication, including metformin, GLP-1s and SGLT2s.1

“We anticipate these results will help establish a new standard of care in the US and around the world,” said Jake Leach, president and CEO of Dexcom. “This is the third Dexcom sponsored randomized controlled trial that has, or will drive, Dexcom CGM to be the standard of care in people with Type 2 diabetes.”

All CONNECT study participants were provided diabetes education on diet and exercise at the start of the study, given a blood glucose meter, and pre-study glucose lowering medications were continued. Half of the study participants were put on Dexcom G7 and half of them used self-monitoring of blood glucose. The CONNECT study initially screened 440 participants across 22 primary care practices throughout the United States, of which 283 eligible participants were randomized to Dexcom G7 or routine care, with 265 completing the 26-week study and analyzed for the key outcomes reported at ADA.

Key outcomes from the study include1:

  • Average 1.6% A1C reduction with Dexcom G7 from baseline mean A1C of 8.8%.

    • Participants using Dexcom G7 experienced on average a 1.6% A1C reduction at 26 weeks, representing a 0.9% greater A1C reduction compared to the control group.

    • Participants using Dexcom G7 with an initial A1C >10% experienced on average a 3.1% A1C reduction, representing a 2.1% greater A1C reduction compared to the control group.

    • 82% of participants had a clinically and statistically significant lower A1C of at least 0.5%.

  • 68% of participants using Dexcom G7 reached <7.5% A1C at 26 weeks and 46% reached < 7.0% A1C at 26 weeks, demonstrating both clinically and statistically significant reductions.

  • The use of Dexcom G7 alone lowered A1C more than any other medication treatment group with a 2.4% reduction in A1c compared to 1.5% in the control group.

  • The use of Dexcom G7 had an additive effect in lowering A1C across all medication groups.

    • In participants using GLP-1s, using Dexcom G7 resulted in a 1.4% reduction in A1C compared to 0.2% in the control group.

    • In participants using SGLT2s, using Dexcom G7 resulted in a 1.8% reduction in A1C compared to 0.7% in the control group.

  • Time in the glucose target range of 70 to 180 mg/dL was five hours per day greater for participants using Dexcom G7 compared to the control group.

    • Those using Dexcom G7 observed overall a clinically significant time in range improvement as early as 1-4 weeks and sustained it through 26 weeks.

    • On average at the end of 26 weeks, participants using Dexcom G7 achieved 62% time in range compared to 41% in the control group.

  • Participants using Dexcom G7 reported a greater satisfaction with the use of Dexcom CGM compared to those using self-monitoring of blood glucose and reduced diabetes distress and disease burden.

    • There was a median Dexcom G7 daily usage of 97% throughout the 26-week study.

A six-month extension phase of the CONNECT randomized controlled trial is currently being conducted, which will provide further data on the sustainable benefits of Dexcom G7 up to 12 months.

The CONNECT study is of similar magnitude to previous randomized controlled trials, such as JDRF, DIAMOND and MOBILE, which demonstrated the benefits of CGM use among insulin using people with diabetes and helped define CGM as the standard of care for people with Type 1 and Type 2 diabetes on intensive and basal insulin.

Expanded CONNECT study outcomes will be presented in conjunction with the 2026 Scientific Sessions of the American Diabetes Association satellite symposium on Sunday, June 7 from 6:45-8:15 p.m. CDT at the Hilton New Orleans Riverside in the St. Charles Ballroom. Outcomes of the study will also be intermittently presented throughout the day, Sunday, June 7, in the Dexcom booth at the 2026 Scientific Sessions of the American Diabetes Association in the main exhibit hall of the Ernest N. Morial Convention Center in New Orleans.

For a detailed overview of Dexcom’s presence at ADA 2026 and more information on the CONNECT study, visit: dexcom.events/2026-ADA.

About Dexcom

Dexcom empowers people to take control of health through innovative biosensing technology. Founded in 1999, Dexcom has pioneered and set the standard in glucose biosensing for more than 25 years. Its technology has transformed how people manage diabetes and track their glucose, helping them feel more in control and live more confidently.

Dexcom. Discover what you’re made of. For more information, visit www.dexcom.com.

Category: IR

1. Oser T, et al. CGM for Adults with Type 2 Diabetes Not on Insulin: The CONNECT Randomized Controlled Trial. Presented at the 2026 Scientific Sessions of the American Diabetes Association, June 6, 2026. New Orleans, LA; USA.

 

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INDUSTRY KEYWORDS: Research Diabetes Clinical Trials Biotechnology Other Health Health Pharmaceutical General Health Science

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Lilly’s triple agonist, retatrutide, drove substantial improvements in weight, A1C, knee osteoarthritis pain, and obstructive sleep apnea, demonstrating its remarkable potential to treat obesity and its complications

PR Newswire

In TRIUMPH-1, participants on retatrutide 12 mg lost an average of 70.3 lbs (28.3%) over 80 weeks, with 65.3% achieving a BMI below 30, no longer meeting the BMI criteria for obesity

In addition to weight loss, retatrutide reduced knee osteoarthritis pain by up to 4.3 points (73.1%) and moderate-to-severe obstructive sleep apnea severity by up to 36.1 events per hour (60.6%)

In TRANSCEND-T2D-1, participants on retatrutide achieved A1C reductions of up to 2.0% and weight loss of up to 36.6 lbs (16.8%) at 40 weeks, with up to 46% achieving a normal A1C

INDIANAPOLIS, June 6, 2026 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY), the maker of Zepbound (tirzepatide) and Foundayo (orforglipron), today announced additional positive results from pivotal Phase 3 trials of retatrutide, an investigational, first-in-class GIP, GLP-1, and glucagon triple hormone receptor agonist, showing substantial weight loss along with meaningful improvements across knee osteoarthritis pain, moderate-to-severe obstructive sleep apnea, and type 2 diabetes – common obesity-related conditions.1,2 The findings from TRIUMPH-1 and TRANSCEND-T2D-1 were presented at the American Diabetes Association (ADA) 86th Scientific Sessions, with TRANSCEND-T2D-1 results simultaneously published in The Lancet.

“Obesity drives more than 200 downstream diseases, yet we have historically treated those conditions one at a time and in silos,” said Ania Jastreboff, M.D., Ph.D., Professor of Medicine & Pediatrics (Endocrinology) at the Yale School of Medicine, Director of the Yale Obesity Research Center (Y-Weight), and lead investigator. “In TRIUMPH-1 and TRANSCEND-T2D-1, treatment with retatrutide resulted in substantial weight reduction together with clinically meaningful improvements in glycemia, knee osteoarthritis pain, and obstructive sleep apnea, with many individuals reaching what are classified as healthy-range weight and normal blood sugar levels. These findings demonstrate what may be possible when we treat obesity and impact overall health, and what this could mean for people living with obesity and its related complications.”

TRIUMPH-1 included an overarching trial for adults with obesity and two nested basket trials: one for knee osteoarthritis pain and one for moderate-to-severe obstructive sleep apnea. Retatrutide met the primary endpoints in each trial at 80 weeks, delivering powerful weight loss along with significant improvements in knee osteoarthritis pain and obstructive sleep apnea. Participants on retatrutide 9 mg and 12 mg lost an average of 64.4 lbs (25.9%) and 70.3 lbs (28.3%), respectively, while those on the 4 mg dose, reached with a single dose escalation step, lost an average of 47.2 lbs (19.0%).3 Notably, 65.3% of participants on retatrutide 12 mg achieved a BMI <30, and 33.3% reached a BMI <25, representing healthy BMI. In a pre-specified extension for participants with baseline BMI ≥35, those continuing on retatrutide 12 mg through 104 weeks lost an average of 85.0 lbs (30.3%). In addition to improving weight measures, retatrutide reduced Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores by up to 4.3 points (73.1%) from a baseline of 6.0 in participants with knee osteoarthritis and apnea-hypopnea index (AHI) by up to 36.1 events per hour (60.6%) from a baseline of 58.6 events per hour in participants with moderate-to-severe obstructive sleep apnea.4

“Across TRIUMPH-1 and TRANSCEND-T2D-1, retatrutide delivered substantial weight loss, meaningful A1C reduction, and improvements in knee osteoarthritis pain and moderate-to-severe obstructive sleep apnea, a breadth and magnitude of outcomes that’s striking to see with a single therapy,” said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health. “By addressing weight, glycemia and obesity-related complications together, these results highlight retatrutide’s potential across the cardiometabolic spectrum and reinforce our commitment to delivering options that meet patients’ needs and preferences.”

In TRANSCEND-T2D-1, retatrutide met the primary and all key secondary endpoints at 40 weeks in adults with type 2 diabetes, delivering significant A1C reduction along with substantial weight loss. For the primary endpoint, participants taking retatrutide achieved average A1C reductions of up to 2.0% from a baseline of 7.9%. Notably, up to 90% of participants taking retatrutide achieved an A1C below 7.0%, the American Diabetes Association’s general target for type 2 diabetes, and up to 85% achieved 6.5% or below, a more stringent goal that may be right for adults earlier in their disease journey.5 In addition, up to 46% of participants achieved an A1C below 5.7%, the threshold for normoglycemia. Individuals taking retatrutide 12 mg also lost an average of 36.6 lbs (16.8%), with weight loss not yet plateauing at 40 weeks.

Across both trials, retatrutide also showed significant improvements from baseline across certain cardiovascular risk factors. In TRIUMPH-1, retatrutide delivered reductions of up to 41.0% in triglycerides, 24.2% in non-HDL cholesterol, 12.3 mmHg in systolic blood pressure, and 9.5 in (24.1 cm) in waist circumference at 80 weeks. In TRANSCEND-T2D-1, retatrutide demonstrated reductions of up to 39.6% in triglycerides, 19.8% in non-HDL cholesterol, 6.4 mmHg in systolic blood pressure, and 4.9 in (12.4 cm) in waist circumference at 40 weeks.6

The types of adverse events seen in TRIUMPH-1 and TRANSCEND-T2D-1 were generally consistent with trials of other incretin-based therapies. In TRIUMPH-1, the most common adverse events with retatrutide (4 mg, 9 mg, 12 mg vs. placebo, respectively) were nausea (28.6%, 38.4%, 42.4% vs. 14.8%), diarrhea (25.2%, 34.1%, 32.0% vs. 13.5%), constipation (23.8%, 25.9%, 26.1% vs. 10.9%), vomiting (10.6%, 22.8%, 25.3% vs. 4.8%), and upper respiratory tract infection (14.2%, 12.2%, 13.1% vs. 11.6%). Incidences of dysesthesia (5.1%, 12.3%, 12.5% vs. 0.9%) and urinary tract infections (7.5%, 8.8%, 8.4% vs. 5.3%) were also observed; these events were generally mild to moderate, the majority resolved during treatment, and most participants continued taking retatrutide. Discontinuation rates due to adverse events were 4.1%, 6.9%, and 11.3% with retatrutide, respectively, compared with 4.9% with placebo.

In TRANSCEND-T2D-1, the most common adverse events with retatrutide (4 mg, 9 mg, 12 mg vs. placebo, respectively) were nausea (16.4%, 19.5%, 26.5% vs. 3.7%), diarrhea (18.7%, 26.3%, 22.8% vs. 4.5%), and vomiting (15.7%, 15.0%, 17.6% vs. 2.2%). Incidences of dysesthesia (4.5%, 2.3%, 4.4% vs. 0.0%) and urinary tract infections (0.7%, 1.5%, 2.9% vs. 0.0%) were also observed; these events were generally mild to moderate, the majority resolved during treatment, and most participants continued taking retatrutide. Discontinuation rates due to adverse events were 2.2%, 4.5%, and 5.1% with retatrutide, respectively, compared with 0.0% with placebo.

About retatrutide

Retatrutide is an investigational once-weekly triple hormone receptor agonist. Retatrutide is a single molecule that activates the body’s receptors for glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), and glucagon. Lilly is studying retatrutide in several Phase 3 clinical trials to evaluate its potential efficacy and safety in obesity and overweight with at least one weight-related medical problem, type 2 diabetes, knee osteoarthritis pain, moderate-to-severe obstructive sleep apnea, chronic low back pain, cardiovascular and renal outcomes, and metabolic dysfunction-associated steatotic liver disease. Retatrutide is an investigational molecule that is legally available only to participants in Lilly’s clinical trials.

About TRIUMPH-1 and the TRIUMPH clinical trial program

TRIUMPH-1 (NCT05929066) is a Phase 3, 80-week, randomized, double-blind, placebo-controlled master trial comparing the efficacy and safety of retatrutide with placebo in adults with obesity or overweight. TRIUMPH-1 included a master trial for obesity and two basket trials for knee osteoarthritis pain or moderate-to-severe obstructive sleep apnea. The study randomized 2,339 participants in a 1:1:1:1 ratio to receive either retatrutide 4 mg, 9 mg, 12 mg, or placebo. Participants randomized to retatrutide initiated treatment with 2 mg once weekly and increased the dose in a step-wise approach every four weeks until reaching the target dose of 4 mg (via one step at 2 mg), 9 mg (via steps at 2 mg, 4 mg and 6 mg) or 12 mg (via steps at 2 mg, 4 mg, 6 mg and 9 mg). TRIUMPH-1 included a pre-specified extension period of 104 weeks. The extension period enrolled 532 participants with BMI ≥35 at week 0 who completed the main 80-week study and tolerated their assigned dose of medication. Participants received retatrutide once weekly for an additional 24 weeks, including a blinded escalation to maximum tolerated dose (9 mg or 12 mg).

The initial TRIUMPH Phase 3 clinical development program is evaluating the safety and efficacy of retatrutide for the treatment of patients with obesity or overweight, moderate-to-severe OSA and obesity, and knee osteoarthritis pain across four global registrational trials. The program, which began in 2023, has enrolled more than 5,800 participants with additional results anticipated over the next year.

About TRANSCEND-T2D-1 and the TRANSCEND-T2D clinical trial program
TRANSCEND-T2D-1 (NCT06354660) is a Phase 3, 40-week, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of retatrutide with placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study randomized 537 participants in a 1:1:1:1 ratio to receive either retatrutide 4 mg, 9 mg or 12 mg, or placebo. The objective of the study was to demonstrate that retatrutide (4 mg, 9 mg or 12 mg) is superior to placebo in A1C reduction from baseline after 40 weeks, in adults with type 2 diabetes who have not taken any anti-diabetes medications for at least 90 days prior to visit one, and are naïve to insulin therapy except for gestational diabetes. Study participants had A1C between ≥7.0% and ≤9.5% and a BMI of ≥23 kg/m2 at visit one. Participants randomized to retatrutide initiated treatment with 2 mg once-weekly and increased the dose in a step-wise approach every four weeks until reaching the target dose of 4 mg (via one step at 2 mg), 9 mg (via steps at 2 mg, 4 mg and 6 mg) or 12 mg (via steps at 2 mg, 4 mg, 6 mg and 9 mg).

The TRANSCEND-T2D Phase 3 clinical trial program is evaluating the safety and efficacy of retatrutide for the treatment of adults with type 2 diabetes across three global registrational trials. The program, which began in 2024, has enrolled more than 2,050 participants and additional results are anticipated over the next year.

Endnotes and References 

  1. National Institute of Diabetes and Digestive and Kidney Diseases. Health Risks of Overweight & Obesity. U.S. Department of Health and Human Services, National Institutes of Health.
  2. Data in this press release are based on the efficacy estimand.
  3. In TRIUMPH-1, change from baseline in body weight (lbs) is computed by multiplying the model-based estimate of percent change from baseline in body weight by baseline body weight.
  4. WOMAC is a patient-reported questionnaire validated in osteoarthritis for assessing pain, stiffness and physical function, with scores normalized to a 0–10 scale where higher values indicate worse symptoms.
  5. American Diabetes Association Professional Practice Committee. (2025). Glycemic Goals and Hypoglycemia: Standards of Care in Diabetes — 2025.Diabetes Care, 48 (Supplement 1): S128–S145.
  6. In TRANSCEND-T2D-1, reductions in non-HDL cholesterol, triglycerides and systolic blood pressure with retatrutide vs. placebo were controlled for family-wise type 1 error in all dose groups except for 4 mg.

FOUNDAYO INDICATION AND SAFETY SUMMARY WITH WARNINGS

Foundayo (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.

  • Foundayo should not be used with other GLP-1 receptor agonist medicines.
  • It is not known if Foundayo is safe and effective for use in children.

Warnings – Foundayo may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

  • Do not use Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
  • Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo.

Foundayo may cause serious side effects, including:

Inflammation of the pancreas (pancreatitis). Stop taking Foundayo and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back.

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness, or feeling jittery.

Serious allergic reactions. Stop using Foundayo and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo.

Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures.

Common side effects

The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before taking Foundayo

  • Tell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works.
  • Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).
  • If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo.
  • Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.

Review these questions with your healthcare provider:
❑ Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Are you pregnant or plan to become pregnant? Foundayo may harm your unborn baby.
❑ Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo.
❑ Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements?

How to take

  • Take Foundayo exactly as your healthcare provider tells you to.
  • Use Foundayo with a reduced-calorie diet and increased physical activity.
  • Take Foundayo by mouth 1 time each day, with or without food.
  • Swallow tablets whole. Do not break, crush, or chew the tablet.
  • If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day.
  • Do not take more than 1 tablet per day.
  • If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment.
  • If you take too much Foundayo, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Learn more

Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com.

This summary provides basic information about Foundayo but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you.

OG CON BS APR2026

ZEPBOUND INDICATIONS AND SAFETY SUMMARY WITH WARNINGS
Zepbound® (ZEHP-bownd) is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with:

  • obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off.
  • moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA.

Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children.

Warnings Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

  • Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
  • Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.

KwikPen®: Do not share your KwikPen with other people, even if the pen needle has been changed. You may give other people a serious infection or get a serious infection from them.

Zepbound may cause serious side effects, including:

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away.

Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back.

Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.

Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound.

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures.

Common side effects
The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using Zepbound

  • Your healthcare provider should show you how to use Zepbound before you use it for the first time.
  • Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.
  • If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound.

Review these questions with your healthcare provider:
❑ Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ Do you take diabetes medicines, such as insulin or sulfonylureas?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound.

  • Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Lilly at 1-800-LillyRx (1-800-545-5979).

How to take

  • Read the Instructions for Use that come with Zepbound.
  • Use Zepbound exactly as your healthcare provider says.
  • Use Zepbound with a reduced-calorie diet and increased physical activity.
  • Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or have another person inject in the back of the upper arm. Do not inject Zepbound into a muscle (intramuscularly) or vein (intravenously).
  • Use Zepbound 1 time each week, at any time of the day.
  • Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.

If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Zepbound is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection.

Learn more
Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to www.zepbound.lilly.com.

This summary provides basic information about Zepbound but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you.

ZP CON BS 25FEB2026

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We’ve been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world’s most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer’s disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we’re motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY

Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about retatrutide as a potential treatment for adults with type 2 diabetes, obesity, and other indications, potential efficacy and tolerability of retatrutide, and the timeline for future readouts, presentations, and other milestones relating to retatrutide and its clinical trials and reflects Lilly’s current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with expectations or study results to date, that retatrutide will prove to be a safe and effective treatment for type 2 diabetes, obesity or other potential indications, that retatrutide will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly’s expectations, see Lilly’s Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. 

Trademarks and Trade Names 
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company’s or their rights thereto. We do not intend the use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.


Refer to:

Niki Biro; [email protected] (Media)

Michael Czapar; [email protected] (Investors)

Eli Lilly and Company logo. (PRNewsFoto, Eli Lilly and Company)

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SOURCE Eli Lilly and Company

All In FutureTech Alliance Provides Strategic Updates: Hainan AIFA Digital Industrial Park, Silicon Photonics Compute Center Planning, and Cross-Border Optical Network Integration

NEW YORK, June 06, 2026 (GLOBE NEWSWIRE) — All In FutureTech Alliance (Nasdaq: AIFA) (“AIFA” or the “Company”) today provided a strategic update. Following the Company’s previously announced signing of agreements to acquire a controlling interest in HyalRoute Communication Group (“HyalRoute”) and advancement of the Hainan AIFA Silicon Photonics Supercomputing Center project, the Company is further accelerating project planning, policy coordination, financing arrangements, and cross-border resource integration around its dual-engine strategy of an “AI infrastructure network powered by optical technologies” and an “AI application services matrix.”

The Company stated that, on June 5, AIFA Chairman and Chief Executive Officer James Li met at Morgan Stanley’s Hong Kong headquarters with senior executives of Morgan Stanley and a delegation from the Lingshui government of Hainan Province. The parties held in-depth discussions regarding AIFA’s proposed leadership role in advancing the construction of silicon photonics compute and storage infrastructure in Hainan and, together with Southeast Asian fiber connectivity resources, building the AIFA Digital Industrial Park.

I. Planning the Overall Layout of the AIFA Digital Industrial Park Around the Hainan Project and Cross-Border Optical Network Synergies

The Company believes that, as global demand for AI computing, cross-border data flows, cloud services, data centers, and digital infrastructure continues to grow, competition among high-value digital infrastructure platforms is evolving from isolated compute capacity competition toward integrated capabilities across “compute + storage + optical transmission + cross-border connectivity + application scenarios.”

Based on this view, and with strong support from the Hainan government, the Company is seeking to upgrade the Hainan project from a standalone compute center plan into a broader AIFA Digital Industrial Park centered on silicon photonics compute, distributed storage, cross-border fiber connectivity, international data transmission, and future AI application incubation.

As previously disclosed, the Hainan AIFA Silicon Photonics Supercomputing Center is proposed to be located on the Company’s own industrial land parcel in Qingshui Bay, Lingshui, Hainan Free Trade Port, leveraging the area’s strategic position as an international submarine cable landing hub to build an offshore silicon photonics supercomputing hub serving global markets. The Company has also previously disclosed that the project is intended to focus on silicon photonics interconnect and optical computing technologies, with business lines including high-end compute leasing, advanced distributed storage, cross-border compute orchestration, AI token output services, and full-cycle value-added services.

The Company believes that, if the Hainan silicon photonics compute center can be effectively integrated in the future with HyalRoute’s Southeast Asian fiber backbone networks, cross-border optical transmission capabilities, and submarine cable resources, it may create a more complete infrastructure closed loop of “optical compute + optical transmission + optical storage,” further enhancing the Company’s differentiated positioning within the global digital infrastructure value chain.

II. Discussions With the Lingshui Government Delegation Regarding Project Implementation and Policy Support

The Company stated that, during the Hong Kong meeting, AIFA management and the Lingshui government delegation of Hainan Province focused on discussions regarding the overall planning of the Hainan AIFA Digital Industrial Park, the project implementation pathway, coordination of supporting resources, areas of potential policy support, and subsequent implementation arrangements.

The Company believes that the Hainan Free Trade Port has unique advantages in areas such as cross-border data pilot programs, international communications channels, tax policies, importation of advanced equipment, and digital industry development. As previously disclosed, the Hainan AIFA Silicon Photonics Supercomputing Center may benefit from a number of Hainan Free Trade Port policy advantages, including offshore tax incentives, duty-free importation of advanced equipment, cross-border data pilot policies, and dedicated international communications channels, which may help reduce project construction and operating costs.

The Company is continuing to communicate with the relevant parties in an effort to obtain active support from the Lingshui government of Hainan Province for project planning, industrial deployment, and subsequent construction. The specific content of any policy support, cooperation model, and implementation arrangements remain subject to further discussions, project progress, and completion of applicable approval procedures.

During the strategic meeting, AIFA also discussed project financing arrangements with Morgan Stanley executives. Under the current preliminary plan, the Company intends to coordinate financing support through multiple financial institutions, including Morgan Stanley, to support the infrastructure construction of the Hainan AIFA Digital Industrial Park.

III. Government Approval Processes Relating to the HyalRoute Project Are Also Underway

The Company further stated that, in addition to the planning of the Hainan AIFA Digital Industrial Park, the governmental approval processes and procedural advancement relating to the Company’s previously announced acquisition of a controlling interest in HyalRoute are also progressing in parallel.

As previously disclosed, HyalRoute owns a pan-ASEAN fiber-optic network, AAE-1 international submarine cable resources, and related cross-border optical transmission capabilities, and the Company views the transaction as an important milestone in its transformation into an AI infrastructure platform with optical technologies at its core. The Company believes that, if the transaction and related approval procedures proceed smoothly, HyalRoute’s fiber backbone networks, cross-border transmission capabilities, submarine cable resources, and regional network operating capabilities will be highly complementary to the Hainan AIFA Silicon Photonics Supercomputing Center.

The Company reminds investors that, with respect to the HyalRoute transaction, the Company has signed equity acquisition agreements with the relevant HyalRoute shareholders; however, those agreements remain subject to agreed closing conditions, regulatory approvals, governance arrangements, and other customary conditions before they can become effective and close. The Company will disclose updates regarding the approval and closing process as appropriate based on subsequent developments.

With respect to HyalRoute itself, the Company is currently engaging with relevant shareholders and the Company’s management regarding post-closing management arrangements following completion of the equity transfer. The Company is also, through outside counsel, requesting that the relevant shareholders involved in the transaction provide additional information and supplemental materials regarding the target company. After completion of the relevant share transfers, the Company expects that investment banks, auditors, and professional advisors will conduct further substantive and detailed due diligence on HyalRoute. At present, certain information available to the Company concerning HyalRoute is based primarily on information provided and communicated by the relevant shareholders.

The transaction will not become substantively effective unless and until all necessary regulatory approvals have been obtained, including approvals from the relevant authorities in China, the United States, and other applicable jurisdictions. The Company also hopes that HyalRoute’s other state-owned shareholders, creditors and debt counterparties, and management team will maintain active and constructive communication with the Company in order to help advance the relevant work in a steady manner.

IV. M&A Progress in Related AI Application Areas

The Company is also evaluating multiple M&A opportunities in AI application sectors, including AI education, AI Poker, and AI drones, as well as related hardware and software projects, and will make disclosures as appropriate based on project progress.

V. Board Reorganization

To better align with the Company’s strategic transformation needs, the Company plans in the near term to advance a reorganization of its Board and an optimization of management, with the goal of introducing professionals more closely aligned with the Company’s new strategic direction and strengthening the Board’s and management team’s capabilities in areas such as AI applications, AI infrastructure, and optical communications, thereby providing stronger organizational support for future strategic execution.

Management Commentary

AIFA Chairman and Chief Executive Officer James Li stated:

“Through completion of the Company’s rebranding and the continued advancement of related acquisition transactions, the Company is undergoing a comprehensive transformation into a future technology platform driven by two core engines: an ‘AI infrastructure network’ and an ‘AI application services matrix.’ Around this strategic direction, the Company is actively screening, evaluating, and advancing multiple potential projects, and will make disclosures as appropriate based on the actual progress of relevant transactions and projects.

We will continue to advance related project planning, financing arrangements, and approval processes in a prudent, compliant, and disciplined manner, while remaining committed to creating long-term value for our shareholders.”

About All In FutureTech Alliance

All In FutureTech Alliance Inc. (Nasdaq: AIFA), formerly known as Allied Gaming & Entertainment Inc, is a growth-oriented company undergoing a strategic transformation from a global experiential entertainment business into an AI-focused digital infrastructure platform. The Company is pursuing opportunities in artificial intelligence infrastructure, silicon photonics-enabled compute, cross-border fiber-optical network transmission, digital infrastructure services, and technology-enabled growth initiatives. Through its proposed AIFA strategic platform, AIFA aims to build an integrated ecosystem combining AI compute capacity, fiber-optic network infrastructure, AI education and AI applications to support long-term value creation.

Forward-Looking Statements

This press release includes forward-looking statements within the safe harbor provisions provided under federal securities laws, including under the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results and, consequently, you should not rely on these forward-looking statements as predictions of future events. Important factors that may affect actual results include, among others, the Company’s ability to execute its growth strategy; the outcome of the Nasdaq hearings; market conditions; regulatory changes; operational challenges; and other risks and uncertainties described under “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the SEC on May 22, 2026, and in subsequent filings with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from the Company’s expectations in any forward-looking statement. Readers are cautioned not to place undue reliance upon any forward-looking statements, including but not limited to the Company’s expectation with respect to the effect of the Reverse Stock Split. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law.

Contact:

Investor Relations: [email protected] 



New Abbott data show many people with diabetes may not recognize symptoms of diabetic ketoacidosis

PR Newswire

  • Diabetic ketoacidosis (DKA) can develop quickly and is not always easy to detect early
  • Ketone monitoring is not yet routine in diabetes care, which may contribute to missed warning signs of DKA and delays in intervention
  • Nearly 60% of pediatric hospitalizations for Type 1 diabetes in the U.S. are associated with DKA1

ABBOTT PARK, Ill., June 6, 2026 /PRNewswire/ — Abbott (NYSE: ABT), the global healthcare leader, announced new data revealing diabetic ketoacidosis (DKA) remains an important, yet often undetected health concern for people living with both Type 1 and Type 2 diabetes. Findings from multiple Abbott studies shared at the American Diabetes Association’s (ADA) June 2026 86th Scientific Sessions show sharp increases in DKA-related hospitalizations across all age groups nationwide. The data reinforces that while diabetes technology has advanced significantly, there are opportunities to better detect rising ketones before DKA develops.

Diabetic Ketoacidosis: Often Misunderstood and Difficult to Recognize

DKA develops in people with diabetes when the body does not have enough insulin and begins breaking down fat for energy, causing ketones to rise to dangerous levels in the blood.2 While traditionally associated with Type 1 diabetes, DKA is increasingly affecting people with Type 2 diabetes. The American Diabetes Association notes that high ketone levels can escalate to DKA within hours and, if left untreated, can lead to coma or death.2 Many people living with diabetes aren’t familiar with DKA or its symptoms, despite clinical guidance recommending ketone testing during periods of elevated glucose, making it a challenge to detect early.

New DKA Data from Abbott Presented at ADA’s Scientific Sessions

At the ADA’s Scientific Sessions, Abbott presented findings from multiple studies analyzing hospitalization, admission diagnosis and insurance claims data to better understand how DKA may be challenging to identify, its rising impact among young people, and a growing prevalence in adults with Type 2 diabetes.

  • DKA may be hard to identify early at hospital admissions: A study of over 100,000 people across the U.S. found that DKA can be difficult to recognize when a person first arrives at the hospital, as early symptoms – such as nausea, fatigue, or stomach pain – overlap with many common illnesses.3 A confirmed diagnosis of DKA depends on blood tests that measure blood sugar, blood pH and/or bicarbonate levels, and ketones, which may not be immediately available at admission.2 These delays highlight the need for approaches to recognize DKA earlier to provide timely care.
  • Better awareness of DKA may help curb hospitalizations: A second study of over 200,000 people showed that between 2017-2024, DKA hospitalization rates among people with Type 1 diabetes increased approximately 24%, rising from 50 to 62 cases per 1,000 individuals. The increase was more pronounced in children than adults.4 Most DKA events led to hospitalization for both children and adults, while severe hypoglycemia rates stayed low and stable, likely due to greater recognition of hypoglycemia and less awareness of DKA risk.4
  • Reducing DKA hospitalizations may improve health outcomes across all ages: One analysis of close to 40,000 pediatric hospitalizations showed DKA now drives nearly 60% of all diabetes-related hospitalizations among youth with Type 1 or Type 2 diabetes.1 Most U.S. hospitalizations among children with diabetes are related to DKA, with the majority requiring inpatient care lasting up to one week and costing up to $38,000 per stay.1 Findings from a separate study with data from millions of people indicate DKA is likely underreported in adults with Type 2 diabetes, and when diagnosed after admission as a secondary condition, is associated with longer hospital stays, higher costs, and increased rates of death.5

“These findings from Abbott show that diabetic ketoacidosis remains a growing challenge to identify, as DKA can develop quickly and mimic common illnesses,” said Kurt Midyett, M.D., pediatric endocrinologist at Saint Luke’s Endocrinology Specialists in Kansas City, Mo. “When early symptoms are misattributed, delays in diagnosis are common and often result in lengthy and costly hospitalization. This data underscores the importance of addressing gaps in recognition to help detect rising ketones before DKA develops.”

The Role of Ketone Monitoring in Diabetes Care

Continuous glucose monitors (CGMs) play an essential role in helping people manage their diabetes by providing real-time glucose insights. However, they do not currently measure ketones and DKA can still develop even when glucose levels appear stable.6 Insights from adults living with Type 1 diabetes show that while some people understand the importance of monitoring ketones, testing is often underused. Rising ketones can progress to DKA within hours, so earlier visibility has the potential to prompt action sooner and reduce risk.6

“These new data make clear that preventing diabetic ketoacidosis starts with recognizing risk earlier,” said Mahmood Kazemi, M.D., chief medical officer for Abbott’s diabetes care business. “DKA remains one of the most preventable emergencies in diabetes care, yet too many people still miss early warning signs when ketones levels begin to rise. These findings underscore the need for better ways to recognize risk sooner and help reduce avoidable hospitalizations.”

As an alternative to existing ketone monitoring options, Abbott has developed dual glucose-ketone sensing technology, which combines continuous glucose and ketone monitoring in a single sensor designed to support both daily diabetes management and help to detect rising ketone levels for people living with diabetes. Abbott announced CE Mark for the systems, called Libre Duo and Libre Duo 10 Day, in May 2026. The company has also filed a regulatory submission with the U.S. Food & Drug Administration (FDA). Libre Duo and Libre Duo 10 Day systems are not yet cleared by the FDA or available for sale in the United States.

Frequently Asked Questions

What is diabetic ketoacidosis?

Diabetic ketoacidosis (DKA) occurs when the body doesn’t have enough insulin. To get energy, the body starts breaking down fat, which releases acids called ketones into the blood.  People in DKA can experience severe dehydration, dangerous changes to potassium and other electrolytes, and coma.  Without prompt treatment, DKA can lead to coma or death.

Can people use urine and blood ketone monitors to test ketones?

Urine and blood ketone monitors are available, but they only offer a snapshot in time and depend on individuals or caregivers recognizing symptoms and deciding to test. Many do not check ketones regularly or lack testing supplies, which can delay action. In a study published in the British Medical Journal Open Diabetes Research & Care, 64% of participants do not test for ketones at all, which can lead to rising ketones that may go unnoticed until a medical emergency develops.7

Can a continuous glucose monitor (CGM) provide information that helps prevent diabetic ketoacidosis?

A CGM, like the FreeStyle Libre 3 Plus sensor, can play an important role in diabetes management, but they are not designed to measure ketones. Because rising ketones are a key driver of diabetic ketoacidosis, relying on glucose data alone may not always provide an early warning before diabetic ketoacidosis (DKA) develops. Abbott has developed a dual glucose-ketone sensing technology in the U.S. that is pending FDA clearance.

About Libre:

Abbott continues to pioneer groundbreaking technology to support people living with diabetes. The company revolutionized diabetes care more than 10 years ago with its world-leading Libre continuous glucose monitoring portfolio8, which today is used by more than 8 million people across over 60 countries. People use Libre technology to see their glucose numbers in real-time, providing insights into how food, activity, or insulin impacts their glucose to help them make progress on their health goals. There is full or partial reimbursement for Libre systems in more than 40 countries.8

About Abbott:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com and on LinkedInFacebookInstagramX, and YouTube.

Important Safety Information: FreeStyle Libre 3 system is for prescription only, for Important Safety Information, please visit https://www.freestyle.abbott/us-en/safety-information.html.

1 Sherr et al. Burden Of Diabetic Ketoacidosis Among Youth With Diabetes: A Hospital Claims Analysis.
2 American Diabetes Association. “Planning for Sick Days.” Accessed February 6, 2026. https://diabetes.org/getting-sick-with-diabetes/sick-days
3 Miller et al. Characterizing the Clinical Presentation of Diabetic Ketoacidosis Hospitalizations in People with Diabetes using Admitting Diagnoses. 
4 Trends in the Prevalence of Diabetic Ketoacidosis and Severe Hypoglycemia in Type 1 Diabetes. 
5 Galindo et al. Mortality And Costs of Diabetic Ketoacidosis Hospitalizations in People with Type 2 Diabetes: Differences Between Primary Vs. Secondary Diagnosis.
6 Dhatariya, et al. Lancet Diabetes & Endocrinology (2025): https://pubmed.ncbi.nlm.nih.gov/41381175/
7
 Hepprich, M., Roser, P., Stiebitz, S., Felix, B., Schultes, B., Schmitz, D., Rutishauser, J., Schubert, S., Aberle, J., & Rudofsky, G. (2023). Awareness and knowledge of diabetic ketoacidosis in people with type 1 diabetes: a cross-sectional, multicenter survey. BMJ open diabetes research & care11(6), e003662. https://doi.org/10.1136/bmjdrc-2023-003662 
8 Data on File, Abbott Diabetes Care. Data based on the number of patients assigned to each manufacturer.

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SOURCE Abbott