FSK Investors Have Opportunity to Lead FS KKR Capital Corp. 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 FS KKR Capital Corp. (NYSE: FSK) between May 8, 2024 and February 25, 2026, inclusive (the “Class Period”), of the important July 6, 2026 lead plaintiff deadline.

So what: If you purchased FS KKR Capital 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 FS KKR Capital class action, go to https://rosenlegal.com/submit-form/?case_id=64089 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 6, 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) FS KKR Capital overstated the effectiveness of its portfolio restructuring efforts for its nonaccrual companies; (2) FS KKR Capital overstated the valuation of its portfolio investments and/or overstated the effectiveness of FS KKR Capital’s portfolio valuation process; (3) FS KKR Capital overstated the durability of its quarterly distribution strategy; and (4) as a result of the foregoing, defendants’ positive statements about FS KKR Capital’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis. When the true details entered the market, the lawsuit claims that investors suffered damages. 

To join the FS KKR Capital class action, go to https://rosenlegal.com/submit-form/?case_id=64089 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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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
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AMGEN PRESENTS NEW DATA ACROSS ITS CARDIOMETABOLIC PORTFOLIO AT AMERICAN DIABETES ASSOCIATION 86TH SCIENTIFIC SESSIONS

PR Newswire

VESALIUS-CV Subgroup Results Show Repatha
®
Reduces Risk of First Major Cardiovascular Events by 29% in People Living with High-Risk Diabetes

New Real-World Data Highlight Treatment Gaps in Current Obesity and Diabetes Care

THOUSAND OAKS, Calif., June 7, 2026 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced new data at the American Diabetes Association (ADA) 86th Scientific Sessions reinforcing its commitment to addressing unmet needs for people living with cardiometabolic conditions and improving patient outcomes.

The data include new Phase 3 VESALIUS-CV subgroup results for Repatha® in patients with high-risk diabetes (microvascular disease, insulin use or diabetic duration ≥10 years) and elevated LDL-C (“bad” cholesterol) without prior heart attack or stroke. Results from the analysis of 6,002 patients demonstrate that Repatha, when added to statins or other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, reduced the risk of the composite primary endpoint of coronary heart disease death, myocardial infarction or ischemic stroke (3-P MACE) by 29% compared with placebo.

Repatha also reduced the risk of a second composite primary endpoint that included ischemia-driven revascularization (4-P MACE) by 21%. The median achieved LDL-C was 45 mg/dL in the Repatha arm compared to 106 mg/dL with placebo (898 patients in the subgroup were part of a lipid sub-study).

Approximately one-third and one-fifth of patients were on a sodium-glucose cotransporter 2 (SGLT2) inhibitor or a glucagon-like peptide-1 (GLP-1) receptor agonist, respectively, at some point during the study. Similar benefits were observed with Repatha regardless of whether patients were treated with these therapies, highlighting the importance of managing multiple risk factors in patients with high-risk diabetes, including treating uncontrolled LDL-C with Repatha.

“People with diabetes face double the risk of heart attack or stroke compared to those without the condition. These VESALIUS-CV results show that early, intensive LDL-C reduction to 45 mg/dL with Repatha is critical to help prevent life-altering cardiovascular events in those with high-risk disease,” said Jay Bradner, M.D., executive vice president, Research and Development, Artificial Intelligence and Data at Amgen. “Cardiometabolic conditions like elevated LDL-C and diabetes often coexist, compounding risk and leading to adverse outcomes. In addition to these data, Amgen is presenting real-world evidence that underscores the pressing need for continued long-term treatment to realize the full benefit of medical therapy for chronic conditions like diabetes, obesity and cardiovascular disease.”

Amgen presented multiple real-world evidence studies showing that while GLP-1 therapies can provide meaningful improvements in glycemic control and body weight, these benefits are closely tied to sustained treatment use. Across studies, persistence and adherence remained low in routine clinical practice, with many patients discontinuing treatment within the first year, potentially limiting the ability to achieve guideline-recommended HbA1c and weight goals and contributing to more modest outcomes than those seen in clinical trials. These findings highlight an important need for new treatment approaches and care strategies that may help patients stay on therapy longer and realize the full potential benefits of GLP-1 medicines.

Key Amgen presentations during ADA 2026:

Repatha (evolocumab) and LDL-C

  • Evolocumab Reduces CV Events in Patients with High-Risk Diabetes: Results from the VESALIUS-CV Trial
    Abstract #1247-OR, Sunday, June 7 from 3:45 – 4:00 p.m. CDT
    These data were simultaneously published in Diabetes Care.

  • Lipid Management in Patients with High-Risk Diabetes Mellitus at Risk for a First Major Atherosclerotic Cardiovascular Event: Findings from the VESALIUS-REAL Global Study
    Abstract #1448-P, Monday, June 8 from 12:30 – 1:30 p.m. CDT

Obesity

  • Real-World HbA1c and Weight Change 6 and 12 Months by GLP-1 Treatment Persistence in Adults with Type 2 Diabetes

    Abstract #1665-P, Presented Sunday, June 7

  • Impact of GLP-1–Based Treatment Discontinuation on Weight Loss and Glycemic Goals Among Patients with Type 2 Diabetes: Quantifying an Opportunity to Improve Treatment Benefits

    Abstract #1706-P, Presented Sunday, June 7

  • A Meta-Analysis of Persistence and Adherence to Glucagon-Like Peptide-1-Based Treatments Among Patients with Type 2 Diabetes in the United States

    Abstract #1691-P, Presented Sunday, June 7

  • A Meta-Analysis of Real-World Effectiveness of Glucagon-Like Peptide-1s Among Patients with Type 2 Diabetes in the United States

    Abstract #20-PUB, Publication

About the VESALIUS-CV Trial
VESALIUS-CV is a Phase 3, double-blind, randomized, placebo-controlled, global clinical trial designed to evaluate the impact of LDL-C lowering with evolocumab on MACE in adults at high CV risk without prior heart attack or stroke. Results were published in the New England Journal of Medicine in November 2025. Repatha demonstrated a 25% relative reduction in the risk of a composite of coronary heart disease (CHD) death, heart attack or ischemic stroke (3-P MACE), and 19% reduction in a broader composite that also included any ischemia-driven arterial revascularization (4-P MACE). Repatha also reduced the risk of heart attack by 36%.

VESALIUS-CV enrolled more than 12,000 patients with known ASCVD or high-risk diabetes, who had no history of heart attack or stroke, an LDL-C ≥ 90 mg/dL, or non-high-density lipoprotein cholesterol (non-HDL-C) ≥ 120 mg/dL, or apolipoprotein B ≥ 80 mg/dL; and treated with highest tolerated dose of statin and/or ezetimibe. The median baseline LDL-C was 122 mg/dL (IQR, 104-149 mg/dL) on local lab testing. Participants were randomized to receive Repatha or placebo in addition to optimized lipid-lowering therapy and were followed for a median of approximately 4.6 years.

Amgen’s Commitment to Cardiometabolic Innovation
Amgen is redefining cardiometabolic care with cutting-edge science rooted in human biology that addresses closely connected cardiovascular and metabolic diseases that lead to serious outcomes or death.

Cardiometabolic conditions commonly coexist and can lead to serious outcomes or death, even though they are treatable.1 Despite advances in lipid-lowering and metabolic therapies, substantial residual cardiovascular risk remains, driven by persistent LDL-C elevation, genetically mediated Lp(a) and obesity-related cardiometabolic dysfunction.2

Leveraging 40+ years of cutting-edge science and human genetics, Amgen is redefining cardiometabolic care and risk management. With years of success in cardiovascular disease with Repatha, Amgen is well positioned to deliver potential breakthrough medicines like MariTide and olpasiran to help address patient needs in cardiometabolic care and multiple interconnected drivers of cardiovascular and metabolic disease.

About Repatha
Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.

Repatha is one of the most extensively studied PCSK9 inhibitors, with clinical and real-world evidence across diverse populations and CV risk profiles.3 The clinical benefits and safety of Repatha have been studied for 15 years in 51 clinical trials with over 57,000 patients.4 Repatha is the only PCSK9 inhibitor to demonstrate a significant reduction of cardiovascular events as both high-risk primary and secondary prevention, with patients achieving and maintain dramatic LDL-C reductions using Repatha only once every two weeks.5,6

Repatha was first approved in 2015 and has since been used by more than 8 million patients globally.7,8 In August 2025, the U.S. Food and Drug Administration broadened the approved use of Repatha to include adults at increased risk for major adverse CV events due to uncontrolled LDL-C. Repatha is approved in 74 countries, including the U.S., Japan, Canada and in all 28 countries that are members of the European Union.9 Applications in other countries are pending.


INDICATIONS


 Repatha® is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor indicated:

  • To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events.
  • As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in:
    • adults with hypercholesterolemia.
    • adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
    • adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).

The safety and effectiveness of Repatha® have not been established in pediatric patients with HeFH or HoFH who are younger than 10 years old or in pediatric patients with other types of hypercholesterolemia. For full prescribing information, visit www.Repatha.com.

 IMPORTANT SAFETY INFORMATION

  • Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha®.

  • Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha®. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha®, treat according to the standard of care, and monitor until signs and symptoms resolve.

  • Adverse Reactions in Adults with Primary Hypercholesterolemia: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.

    From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha®-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for Repatha® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%). 

  • Adverse Reactions in the FOURIER Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: diabetes mellitus (8.8% Repatha®, 8.2% placebo), nasopharyngitis (7.8% Repatha®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha®, 4.8% placebo).

    Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with Repatha® compared with 7.7% in patients that received placebo. 

  • Adverse Reactions in Pediatric Patients with HeFH: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: nasopharyngitis, headache, oropharyngeal pain, influenza, and upper respiratory tract infection.

  • Adverse Reactions in Adults and Pediatric Patients with HoFH: In a 12-week study in 49 patients, the adverse reactions that occurred in at least two patients treated with Repatha® and more frequently than placebo were: upper respiratory tract infection, influenza, gastroenteritis, and nasopharyngitis. In an open-label extension study in 106 patients, including 14 pediatric patients, no new adverse reactions were observed.

  • Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha®.

Please see full Prescribing Information. 

About Obesity

Obesity is a complex chronic disease influenced by genetic, behavioral and environmental factors, that increases the risk of many other serious related diseases and conditions, including type 2 diabetes, heart failure, sleep apnea, and cardiovascular disease.10,11 The worldwide prevalence of obesity more than doubled between 1990 and 2022.12 In the U.S., more than two in five adults (40.3%) are living with obesity.13 Globally, 1 billion people are living with obesity.14

Obesity is linked to a marked reduction in quality of life and an array of serious medical complications and conditions.15,16 Though leading medical organizations, including the American Medical Association and the European Health Commission, recognize obesity as a chronic disease, only 1%-3% of eligible adults in the U.S. are prescribed medication for chronic weight management.17,18,19

For more information about Amgen’s approach to addressing obesity and related conditions, visit https://www.amgen.com/obesity.

About Amgen 
Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world’s toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines.

More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases and obesity and obesity-related conditions.

Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.

For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube, Facebook, TikTok and Threads.

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeOne Medicines Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast), our acquisitions of ChemoCentryx, Inc., Dark Blue Therapeutics, Ltd. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon’s business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

CONTACT: Amgen, Thousand Oaks
Madison Howard, 773-636-4910 (media)
Elissa Snook, 609-251-1407 (media)
Casey Capparelli, 805-447-1746 (investors) 

REFERENCES

  1. Eroglu T, Capone F, Schiattarella GG. The evolving landscape of cardiometabolic diseases. EBioMedicine. 2024 Nov;109:105447. doi: 10.1016/j.ebiom.2024.105447. Epub 2024 Nov 4. PMID: 39500010; PMCID: PMC11570325. 
  2. Tan SH, Wu JL, Zhuo SX, Zhang Y, Wang M. Residual risk in atherosclerotic cardiovascular disease after statin therapy: Clinical mechanisms and management strategies. World J Cardiol. 2026 Feb 26;18(2):114960. doi: 10.4330/wjc.v18.i2.114960. PMID: 41694036; PMCID: PMC12897005.
  3. Data on File; Amgen, 2025.
  4. Data on File; Amgen, 2025.
  5. Ndumele, C. E., & Blumenthal, R. S. (2025). VESALIUS and the Anatomy of High-Risk Prevention. New England Journal of Medicine. https://doi.org/10.1056/nejme2515447
  6. Marston, N. A., Bohula, E. A., Bhatia, A. K., et al. (2026). Evolocumab to reduce first major cardiovascular events in patients without known significant atherosclerosis and with diabetes: Results from the VESALIUS‑CV trial. JAMA. https://doi.org/10.1001/jama.2026.3277
  7. Shapiro MD. Circulation. 2022;146(15):1120-1122. 
  8. Rao SV, O’Donoghue ML, Ruel M, et al. Circulation. 2025;151(13):e771-e862.
  9. Data on File. Amgen, 2025.
  10. Singh V, Sun J, Cheng S, Kwan AC, Velazquez A. Obesity as a Chronic Disease: A Narrative Review of Evolving Definitions, Management Strategies, and Cardiometabolic Prioritization. Adv Ther. 2025;42(11):5341-5364.
  11. Health Risks of Overweight & Obesity. National Institute of Diabetes and Digestive and Kidney Diseases. https://www.niddk.nih.gov/health-information/weight-management/adult-overweight-obesity/health-risks. Published May 2023. Accessed April 27, 2026.
  12. World Health Organization. Obesity and overweight fact sheet. https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight. Updated March 1, 2024. Accessed May 14, 2026.
  13. Fryar CD, Afful J, Saif NT. Prevalence of overweight, obesity, and severe obesity among adults age 20 and over: United States, 1960–1962 through August 2021-August 2023. NCHS Health E-Stat. 2026 Feb;(111):1–7.
  14. NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in underweight and obesity from 1990 to 2022: a pooled analysis of 3663 population-representative studies with 222 million children, adolescents, and adults. Lancet. 2024 Mar 16;403(10431):1027-1050.
  15. Centers for Disease Control and Prevention. Consequences of Obesity. https://www.cdc.gov/obesity/basics/consequences.html. Accessed November 12, 2024.
  16. Hecker J, Freijer K, Hiligsmann M, Evers SMAA. Burden of disease study of overweight and obesity; the societal impact in terms of cost-of-illness and health-related quality of life. BMC Public Health. 2022;22:46.
  17. Burki T. European Commission classifies obesity as a chronic disease. Lancet Diabetes Endocrinol. 2021;9(7):[418].
  18. American Medical Association House of Delegates, 2013. Recognition of obesity as a disease. Resolution 420 (A-13). May 16, 2013. Chicago, USA.
  19. Kim C, Ross JS, Jastreboff AM, et al. JAMA. 2025;333(24):2203–2206.

Amgen Logo. (PRNewsFoto/Amgen) (PRNewsFoto/)

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SOURCE Amgen

GoHealth, Inc. to strengthen its position ahead of AEP 2026 through Restructuring Process supported by key stakeholders

Initiates voluntary prepackaged Chapter 11 process to implement Restructuring Transactions that have the support of 100% of its lenders, over 60% of the holders of GoHealth, Inc. Class A Common Stock, and over 99% of the holders of GoHealth Holdings, LLC interests.

Plans to continue operations without interruption and it is business-as-usual for the Company in providing service for existing Medicare consumers and partners.

CHICAGO, June 07, 2026 (GLOBE NEWSWIRE) — GoHealth, Inc. (“GoHealth” or the “Company”), a health insurance marketplace and Medicare-focused digital health company, announced that GoHealth and certain of its subsidiaries have voluntarily filed chapter 11 petitions (the “Chapter 11 Cases”) with the United States Bankruptcy Court for the District of Delaware (the “Bankruptcy Court”) to implement the transactions set forth in the Joint Prepackaged Chapter 11 Plan of GoHealth, Inc. and Its Debtor Affiliates Docket No. 4 (the “Plan”). The Plan will transition ownership of the Company to certain of GoHealth’s lenders, reinstate the preferred equity of GoHealth, Inc., provide for payment in full of trade payables and other ordinary course obligations, provide a cash payment to holders of GoHealth common equity, protect GoHealth’s critical relationships with customers and health insurance carriers, and position GoHealth for future success.

GoHealth has already received votes in favor of the Plan from 100% of its lenders, over 60% of the holders of GoHealth, Inc. Class A Common Stock, and over 99% of the holders of GoHealth Holdings, LLC interests. While GoHealth believes these votes are sufficient for the Bankruptcy Court to confirm the Plan under the applicable requirements of the United States Bankruptcy Code, GoHealth anticipates that additional equityholders may vote to accept the Plan in the coming weeks.

GoHealth expects to proceed through the restructuring process quickly and efficiently given the significant support for its prepackaged Plan, with the expectation that it will emerge before the start of the 2026 annual enrollment period (“AEP”).

“The steps we are taking today will provide GoHealth with new owners and a strong financial foundation. This restructuring will enable the Company to continue driving innovation to support Medicare consumers as they assess their current coverage and service needs, with agility and excellence, and to ensure personalized service with differentiated quality,” said Vijay Kotte, Chief Executive Officer of GoHealth. “We plan to continue operations without interruption and believe the support of our key financial partners demonstrates their confidence in our business and the opportunities ahead. We thank our customers, suppliers and business partners for their ongoing partnership and support, and our employees for their continued hard work and dedication. We believe that we will emerge from this process well positioned and look forward to further securing and serving our current members, driving cutting-edge innovation, and bolstering the integral role we play in the consumer value chain.”

Additional Information

Under the Plan, the Company intends to continue operating in the ordinary course during the pendency of the Chapter 11 Cases and to pay vendors, suppliers, and certain other business partners in full for goods received and services provided before and after the Petition Date. To do so, GoHealth has filed a number of customary motions with the Bankruptcy Court, seeking authority to maintain uninterrupted operations and uphold its current and future commitments to employees, vendors, suppliers, customers, and various other stakeholders. Additionally, in connection with the Chapter 11 Cases, the Company expects that (i) the Class A common stock will be delisted from The Nasdaq Global Market and (ii) trading of the Class A common stock thereon will be suspended and following the suspension thereof, the Class A common stock may be quoted on the OTCID Basic Market or another over-the-counter market.

If you would like to obtain a copy of any of the Bankruptcy Court filings and other information related to the proceedings, you should contact Donlin, Recano & Company, LLC, the claims and noticing agent retained by the Debtors in the Chapter 11 Cases by: (a) writing via first class mail, to Donlin, Recano & Company, LLC, c/o Angeion Group, 200 Vesey Street, 24th Floor, New York, NY 10281; (b) writing via electronic mail to [email protected]; or (c) calling the Debtors’ restructuring hotline at +1-877-583-1578 (U.S./Canada, toll-free) or +1-332-284-1398 (International, toll). You may also obtain copies of any pleadings filed in the Chapter 11 Cases (i) for a fee via PACER at https://www.deb.uscourts.gov or (ii) at no charge from Donlin, Recano & Company, LLC by accessing the Debtors’ restructuring website at https://www.bankruptcy.angeiongroup.com/gohealth.

Advisors

Kirkland and Ellis LLP is serving as legal counsel and Alvarez & Marsal North America, LLC is serving as restructuring advisor to GoHealth in connection with these Chapter 11 Cases.

About GoHealth, Inc.

GoHealth is a health insurance marketplace and Medicare-focused digital health company whose purpose is to compassionately ensure consumers’ peace of mind when making healthcare decisions so they can focus on living life. For many of these consumers, enrolling in a health insurance plan is confusing and difficult, and seemingly small differences between health plans may lead to significant out-of-pocket costs or lack of access to critical providers and medicines. GoHealth’s proprietary technology platform leverages modern machine-learning algorithms, powered by over two decades of insurance purchasing behavior, to reimagine the process of matching a health plan to a consumer’s specific needs. Its unbiased, technology-driven marketplace coupled with highly skilled licensed agents has facilitated the enrollment of millions of consumers in Medicare plans since GoHealth’s inception.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are made in reliance upon the safe harbor provision of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release may be forward-looking statements. Statements regarding approval from the Bankruptcy Court with respect to motions or other requests expected to be made throughout the course of the Chapter 11 Cases, including confirmation of the Plan; the timing and implementation of the transactions contemplated by the Disclosure Statement and the Plan; the effects of the Chapter 11 Cases on the Company and its various constituents, including vendors, suppliers, customers, health plans, brokers, employees and other business counterparties; the Company’s ability to continue operating in the ordinary course, including continuing to serve customers and pay employees, vendors, suppliers and customers in the ordinary course or in the form of reinstatement of trade payables and other ordinary course obligations; the Company’s ability to obtain additional votes from equityholders in support of the Plan and the Company’s belief regarding the sufficiency of such support to satisfy the applicable requirements for acceptance of the Plan under the United States Bankruptcy Code; the potential benefits of the transactions contemplated by the Plan; the Company’s expectation that the Class A common stock will be delisted and that trading will be suspended immediately; and the potential effects of such transactions on the Company’s financial position, capital structure, outstanding debt, interest expense and business are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “likely,” “future” or “continue” or the negative of these terms or other similar expressions although not all forward-looking statements contain these identifying words. The forward-looking statements in this press release are only predictions, projections and other statements about future events that are based on current expectations and assumptions. Accordingly, we caution you that any such forward-looking statements are not guarantees of future events or performance and are subject to risks, assumptions and uncertainties that are difficult to predict. Although we believe that the expectations reflected in these forward-looking statements are reasonable as of the date made, actual results may prove to be materially different from the results expressed or implied by the forward-looking statements.

These forward-looking statements involve risks and uncertainties, both known and unknown, that may cause the Company’s actual results to differ materially from those indicated in the forward-looking statements. Factors that could cause actual future events to differ materially from the forward-looking statements in this press release include, but are not limited to: our ability to continue as a going concern; our ability to continue our business operations following the commencement of the Chapter 11 Cases; the Company’s ability to obtain approval from the Bankruptcy Court with respect to motions or other requests made to the Bankruptcy Court throughout the course of the Chapter 11 Cases, including confirmation of the Plan; the Company’s ability to confirm and consummate the Plan and complete the restructuring on the terms and timeline currently contemplated or at all, and the Company’s ability to realize the intended benefits of the restructuring; our ability to obtain votes from additional equityholders in support of the Plan; the effects of the Chapter 11 Cases on the Company and its various constituents, including vendors, suppliers, customers, health plans, brokers, employees and other business counterparties and including whether ordinary course obligations are paid in full for trade payables and other ordinary course obligations; the length of time the Company will operate under the Chapter 11 process and the supervision of the Bankruptcy Court; the effects of the Chapter 11 Cases on the Company’s liquidity, cash flows, access to financing, financial condition and results of operations; the delisting of the Company’s Class A common stock from Nasdaq and the quotation or trading of the Class A common stock on the over-the-counter market during the pendency of the Chapter 11 Cases; the cancellation of the Company’s and GoHealth Holdings, LLC’s existing equity interests (other than the Series A redeemable convertible preferred stock) pursuant to the Plan, with existing holders of Class A common stock and limited liability units of GoHealth Holdings, LLC receiving limited recovery; the risk that, if the Plan is confirmed and consummated as contemplated, the restructuring will result in a change of control of the reorganized company and existing equity holders (other than the Series A redeemable convertible preferred stock) will lose their ownership, voting and other rights and interests in the Company and GoHealth Holdings, LLC; risks related to the Company’s indebtedness; employee attrition and the Company’s ability to retain senior management and other key personnel, including due to distractions and uncertainties related to the Chapter 11 process; whether the Company’s vendors, suppliers, customers, health plans, brokers and other business counterparties might lose confidence in the Company’s ability to reorganize its capital structure successfully and seek to establish alternative commercial relationships; the diversion of management’s attention as a result of the Chapter 11 Cases; increased administrative and legal costs related to the Chapter 11 Cases; and objections to, or other actions that may delay or prevent confirmation or consummation of, the Plan by creditors, equity holders, regulators or other parties in interest.

These forward-looking statements speak only as of the date of this press release and are subject to a number of additional important factors that could cause actual results to differ materially from those in the forward-looking statements, including the factors described in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other filings the Company has made or will make with the Securities and Exchange Commission including any of the Company’s Current Reports on Form 8-K and Quarterly Reports on Form 10-Q. You should read this press release and the documents that we reference herein completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Media Inquiries

[email protected]



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:     

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

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/ —

Rosen Law Firm Logo

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.

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

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SOURCE THE ROSEN LAW FIRM, P. A.

SRAD Investors Have Opportunity to Lead Sportradar Group AG 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, 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
     [email protected]
     www.rosenlegal.com

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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

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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.

 

Media Contact

James McIntosh

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Investor Contact

Sean Christensen

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KEYWORDS: United States North America California

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

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