TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to significantly reduce both the signs and symptoms and the progression of structural damage in adults living with active psoriatic arthritis

PR Newswire

TREMFYA® demonstrated clinically meaningful and statistically significant efficacy in patients with active psoriatic arthritis at risk for structural damage in Phase 3b study

Topline results demonstrate efficacy across multiple domains at Week 24, reinforcing TREMFYA® as a first-line treatment option for patients with active psoriatic arthritis


SPRING HOUSE, Pa.
, April 4, 2025 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) today announced that the TREMFYA® (guselkumab) Phase 3b APEX study achieved both its primary endpoint (ACR20a) of reducing signs and symptoms and its major secondary endpoint of reducing progression of structural damage as measured by radiographic progression at 24 weeks, in adults living with active psoriatic arthritis (PsA), compared to placebo.1

TREMFYA® is the first and only fully-human, dual-acting monoclonal antibody approved to treat PsA that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including active psoriatic arthritis.2,3,4,5,6

In the Phase 3b APEX study, TREMFYA®-treated patients also exhibited significantly less progression of structural damage versus patients receiving placebo at Week 24 as assessed by the PsA modified van der Heijde-Sharp (vdH-S) score, which includes joint space narrowing and erosion subscores. Data were consistent with the well-established safety profile of TREMFYA® with no new safety signals identified.1

“Psoriatic arthritis can be a progressive and debilitating disease, and without early identification and treatment, patients may experience irreversible joint damage that significantly impacts their daily activities,” said Terence Rooney, Vice President, Rheumatology Disease Area Leader, Johnson & Johnson Innovative Medicine. “These new topline data highlight the importance of addressing both inflammation and structural damage at the source as early as possible. As the only IL-23 treatment to show significant inhibition of structural damage, TREMFYA equips healthcare providers with critical data so their patients do not have to compromise their future joint health.”

APEX is a Phase 3b study with long-term extension data through three years that will further assesses the sustained efficacy of TREMFYA® on inhibition of structural damage in patients with active PsA. Results from the APEX study are being prepared for presentation at upcoming medical congresses.

Editor’s notes:  

a.  ACR20 response is defined as both at least 20 percent improvement from baseline in the number of tender and number of swollen joints, and a 20 percent improvement from baseline in three of the following five criteria: patient GA, physician GA, functional ability measure (HAQ-DI), patient-reported pain using a visual analog scale, and erythrocyte sedimentation rate or C-reactive protein.7

ABOUT APEX STUDY (NCT04882098)

APEX is a multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA who are biologic naïve and have had an inadequate response to standard therapies (e.g., csDMARDs, apremilast, and/or NSAIDs). The treatment duration includes a 24-week, double-blind, placebo-controlled period, followed by a 24-week active treatment period, followed by a 12-week safety follow-up period. For patients who agree to enter the long-term extension, an additional 2 years of active treatment period is scheduled prior to the final safety follow-up.8

ABOUT PSORIATIC ARTHRITIS

Psoriatic arthritis (PsA) is a chronic, immune-mediated, inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (a type of inflammation in the fingers and toes that can result in a swollen, sausage-like appearance), axial disease and the skin lesions associated with plaque psoriasis (PsO).9,10,11 The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age.12 Nearly half of patients with PsA experience moderate fatigue and about one-third suffer from severe fatigue as measured by the modified fatigue severity scale.13 In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.14 Studies show up to 30% of people with plaque PsO also develop PsA.11 

ABOUT TREMFYA® (guselkumab)

Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known.

TREMFYA® is a prescription medicine approved in the U.S. to treat:

  • adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light).
  • adults with active psoriatic arthritis.
  • adults with moderately to severely active ulcerative colitis.
  • adults with moderately to severely active Crohn’s disease.10

TREMFYA® is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis.

Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: www.tremfya.com.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TREMFYA®?

TREMFYA® is a prescription medicine that may cause serious side effects, including:

  • Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:

      o    fainting, dizziness, feeling lightheaded (low blood pressure)

      o    swelling of your face, eyelids, lips, mouth, tongue or throat

o    trouble breathing or throat tightness

o    chest tightness

o    skin rash, hives

o    o itching

  • Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®.

Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:

       o    fever, sweats, or chills

       o    muscle aches

       o    weight loss

       o    cough

       o    warm, red, or painful skin or sores on your body different from your psoriasis

o    diarrhea or stomach pain

o    shortness of breath

o    blood in your phlegm (mucus)

o    burning when you urinate or urinating more often than normal

  • Liver problems. With the treatment of Crohn’s disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA®. Your healthcare provider may stop treatment with TREMFYA® if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms:

       o    unexplained rash

       o    vomiting

       o    tiredness (fatigue)

       o    yellowing of the skin or the whites of your eyes

o    nausea

o    stomach pain (abdominal)

o    loss of appetite

o    dark urine

Do not use TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®.

Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you:

  • have any of the conditions or symptoms listed in the section “What is the most important information I should know about TREMFYA®?”
  • have an infection that does not go away or that keeps coming back.
  • have TB or have been in close contact with someone with TB.
  • have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®.
  • are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby.
    Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®. You can enroll by visiting www.mothertobaby.org/ongoing-study/tremfya-guselkumab, by calling 1-877-311-8972, or emailing [email protected]. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy.
  • are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of TREMFYA®?

TREMFYA® may cause serious side effects. See “What is the most important information I should know about TREMFYA®?”

The most common side effects of TREMFYA® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, and bronchitis.

These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects.

Use TREMFYA® exactly as your healthcare provider tells you to use it.

Please read the full Prescribing Information, including Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Dosage Forms and Strengths: TREMFYA® is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion.

ABOUT JOHNSON & JOHNSON 

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.  

Learn more at https://www.jnj.com/ or at https://innovativemedicine.jnj.com/ 

Follow us at @JNJInnovMed.

Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. 

CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS 

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at

www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

REFERENCES

1 Data on file
2 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn’s and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504.
3 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217.
4 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
5 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc.
6 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company.
7 Felson, D. T., & LaValley, M. P. The ACR20 and defining a threshold for response in rheumatic diseases: too much of a good thing. Arthritis Research & Therapy, 2014:16(1), 101. https://doi.org/10.1186/ar4428
8 ClinicalTrials.gov. A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX). Identifier: NCT04882098. Available at: https://clinicaltrials.gov/study/NCT04882098. Accessed March 2025.
9 Donvito T., CreakyJoints: What Is Dactylitis? The ‘Sausage Finger’ Swelling You Should Know About. Available at: https://creakyjoints.org/symptoms/what-is-dactylitis/. Accessed March 2025.
10 Belasco J., Wei N. Psoriatic Arthritis: What is Happening at the Joint? Rheumatol Ther. 2019 Sep;6(3):305-315. Available at: https://pubmed.ncbi.nlm.nih.gov/31102105/. Accessed March 2025.
11 Gower, T. Enthesitis and PsA. Arthritis Foundation. Available at: https://www.arthritis.org/health-wellness/about-arthritis/related-conditions/physical-effects/enthesitis-and-psa. Accessed March 2025.
12 National Psoriasis Foundation. About Psoriatic Arthritis. Available at: https://www.psoriasis.org/about-psoriatic-arthritis/. Accessed March 2025.
13 Husted J.A., et al. Occurrence and correlates of fatigue in psoriatic arthritis. Ann Rheum Dis, 2008:68(10), 1553–1558. Available at: https://doi.org/10.1136/ard.2008.098202. Accessed March 2025.
14 Haddad A., Zisman D. Comorbidities in Patients with Psoriatic Arthritis. Rambam Maimonides Med J 2017 Jan 30;8(1):e0004. Available at: https://doi.org/10.5041/RMMJ.10279. Accessed March 2025.
15 TREMFYA® Prescribing Information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf Accessed March 2025.



Media contact:


Craig Stoltz


[email protected] 



Investor contact:


Lauren Johnson
[email protected] 

 

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SOURCE Johnson & Johnson

/DISREGARD RELEASE: Visionary Holdings Inc./

PR Newswire

We are advised by Visionary Holdings Inc. that journalists and other readers should disregard the news release, “$1 Billion Financing Secured, Visionary Accelerates Its Battery Swap Layout in Hong Kong“, issued on March 14, 2025 by Visionary Holdings Inc. over PR Newswire, as the release contained erroneous information.

SOURCE Visionary Holdings Inc.

SPHERE STUDIOS ANNOUNCES TWO NEW EXPERIENCES IN PRODUCTION

PR Newswire


THE WIZARD OF OZ AT SPHERE



In Collaboration with Warner Bros. Discovery, Google, and Magnopus 



and



FROM THE EDGE



From Academy Award-Winning Directors E. Chai Vasarhelyi and Jimmy Chin


BURBANK, Calif.
, April 4, 2025 /PRNewswire/ — Sphere Entertainment Co. (NYSE: SPHR) announced today two new projects – The Wizard of Oz at Sphere and From The Edge – currently in production from Sphere Studios. Both productions are part of The Sphere ExperienceTM, Sphere’s slate of original immersive content. The Wizard of Oz at Sphere is set to open on August 28, 2025, and From The Edge is set to debut in 2026.

Jim Dolan, Executive Chairman and CEO of Sphere Entertainment, said: “Our goal for The Sphere Experience is a diverse slate that leverages Sphere’s power as an experiential medium. The Wizard of Oz at Sphere and From The Edge will push that vision forward in different ways.”



THE WIZARD OF OZ AT SPHERE

The original 1939 film, TheWizard of Oz, will be presented as a fully immersive experience for Sphere. In collaboration with Warner Bros. Discovery; Google; and Magnopus, Sphere will use cutting-edge technologies to enhance the original film. The Wizard of Oz at Sphere will maintain the integrity of the original while pushing the boundaries of Sphere’s experiential medium.

The creative team behind The Wizard of Oz at Sphere includes Academy Award and Emmy-nominated producer Jane Rosenthal (The Irishman); Academy Award-winning visual effects specialist Ben Grossmann (Hugo); Academy Award-winning editor Jennifer Lame (Oppenheimer); and Creative Director Zack Winokur (Little Island).



FROM THE EDGE

 

Directed by Academy Award winners E. Chai Vasarhelyi and Jimmy Chin (Free Solo) From The Edge will feature premier athletes – free diver Alenka Artnik, skier Markus Eder, rock climber Alex Honnold, BASE jumper Katie Hansen Lajeunesse, and surfer Kai Lenny – and take audiences inside the world of extreme sports.

All five athletes are being captured on location by Big SkyTM, Sphere Entertainment’s proprietary camera system developed to capture images at the scale and fidelity necessary for Sphere’s display. Filming is underway in locations in Jordan, Dubai, Switzerland, the Bahamas, Austin, Las Vegas, and Maui.

From The Edge is produced by Vasarhelyi and Chin and their Little Monster Films along with Evan Hayes and Callum Greene. Executive Producers are Anna Barnes (Little Monster Films) and Nick Martini (Stept Studios). 

To be the first to know more about The Wizard of Oz at Sphere and From The Edge, please visit thesphere.com and sign up for The Inner Circle.

For press assets, please click here.

About Sphere

Sphere is a next-generation entertainment medium that is redefining the future of live entertainment. A venue where the foremost artists, creators, and technologists create extraordinary experiences that take storytelling to a new level and transport audiences to places both real and imagined. The venue hosts original Sphere Experiences from leading Hollywood directors; concerts and residencies from the world’s biggest artists; and premier marquee events. The first Sphere venue opened in Las Vegas in September 2023, and is a new Las Vegas landmark, powered by cutting-edge technologies that ignite the senses and enable audiences to share experiences at a never-before-seen scale. More information is available at thesphere.com.

Contact

Sphere Entertainment – [email protected]

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SOURCE Sphere Entertainment Co.

SABINE ROYALTY TRUST ANNOUNCES MONTHLY CASH DISTRIBUTION FOR APRIL 2025

PR Newswire


DALLAS
, April 4, 2025 /PRNewswire/ — Argent Trust Company, as Trustee of the Sabine Royalty Trust (NYSE: SBR), today declared a cash distribution to the holders of its units of beneficial interest of $0.503880 per unit, payable on April 29, 2025, to unit holders of record on April 15, 2025. Sabine’s cash distribution history, current and prior year financial reports and tax information booklets, a link to filings made with the Securities and Exchange Commission and more can be found on its website at http://www.sbr-sabine.com/. Additionally, printed reports can be requested and are mailed free of charge.

This distribution reflects primarily the oil production for January 2025 and the gas production for December 2024, which is considered current production. Preliminary production volumes are approximately 102,540 barrels of oil and 1,410,501 Mcf of gas. Preliminary prices are approximately $44.22 per barrel of oil and $2.62 per Mcf of gas.

This month’s distribution is higher than the previous month’s primarily due to an increase in oil and gas production, along with an increase in the price of natural gas, partially offset by a decrease in the price of oil. This month’s realized oil price of $44.22 per barrel is significantly lower than national averages due to multiple prior period adjustments from various remitters. However, the price of oil for the current production month averaged $71.56 per barrel.

The table below compares this month’s production and prices to the previous month’s:

Net to Trust Sales

Volumes (a)

Average Price (a)

 

Oil (bbls)

 

Gas (Mcf)

Oil

(per bbl)

Gas

(per Mcf)

Current Month

102,540

1,410,501

$44.22

$2.62

Prior Month

45,827

1,044,259

$69.44

$1.86

(a) Sales volumes are recorded in the month the Trust receives and identifies the related royalty income. Because of this, sales volumes and pricing may fluctuate from month to month based on the timing of cash receipts.

Revenues are only distributed after they are received, verified, and posted. Most energy companies normally issue payment of royalties on or about the 25th of every month, and depending on mail delivery, a varying amount of royalties are not received until after the revenue posting on the last business day of the month. The revenues received after that date will be posted within 30 days of receipt.

Due to the timing of the end of the month of March, approximately $119,000 of revenue received will be posted in the following month of April in addition to normal cash receipts received during April. Since the close of business in March and prior to this press release, approximately $180,000 in revenue has been received.

The 2024 Annual Report on Form 10-K has been filed with the Securities and Exchange Commission, and the December 31, 2024, Reserve Summary is available on the Sabine website at http://www.sbr-sabine.com/.

Forward-looking Statements

Any statements in this press release about future events or conditions, and other statements containing the words “estimates,” “believes,” “anticipates,” “plans,” “expects,” “will,” “may,” “intends” and similar expressions, other than historical facts, constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Factors or risks that could cause the Trust’s actual results to differ materially from the results the Trustee anticipates include, but are not limited to the factors described in Part I, Item 1A, “Risk Factors” of the Trust’s Annual Report on Form 10-K for the year ended December 31, 2024, and Part II, Item 1A, “Risk Factors” of subsequently filed Quarterly Reports on Form 10-Q.

Actual results may differ materially from those indicated by such forward-looking statements. In addition, the forward-looking statements included in this press release represent the Trustee’s views as of the date hereof. The Trustee anticipates that subsequent events and developments may cause its views to change. However, while the Trustee may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Trustee’s views as of any date subsequent to the date hereof.

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SOURCE Sabine Royalty Trust

AerCap Holdings N.V. To Release First Quarter 2025 Financial Results on April 30, 2025

PR Newswire


DUBLIN
, April 4, 2025 /PRNewswire/ — AerCap Holdings N.V. (“AerCap” or the “Company”) (NYSE: AER) today announced it will host a conference call and webcast for investors and analysts on Wednesday, April 30, 2025 at 8:30 a.m. Eastern Time to review its first quarter 2025 financial results.

AerCap’s first quarter 2025 earnings press release will be released before financial markets open in the United States on April 30, 2025. A copy of the press release will be posted on the “Investors” section of AerCap’s website at www.aercap.com. At the same time, the presentation slides for the conference call will also be posted on AerCap’s website.

The call can be accessed live by dialing (U.S./Canada) +1 929-477-0402 or (International) +353 1 246 5638 and referencing code 9290960 at least 5 minutes before start time, or by visiting AerCap’s website at www.aercap.com under “Investors”.

The webcast replay will be archived on the “Investors” section of the company’s website for one year.

About AerCap

AerCap is the global leader in aviation leasing with one of the most attractive order books in the industry. AerCap serves approximately 300 customers around the world with comprehensive fleet solutions. AerCap is listed on the New York Stock Exchange (AER) and is based in Dublin with offices in Shannon, Miami, Singapore, Memphis, Amsterdam, Shanghai, Dubai and other locations around the world.

Forward-Looking Statements

This press release contains certain statements, estimates and forecasts with respect to future performance and events. These statements, estimates and forecasts are “forward-looking statements”. In some cases, forward-looking statements can be identified by the use of forward-looking terminology such as “may,” “might,” “should,” “expect,” “plan,” “intend,” “will,” “aim,” “estimate,” “anticipate,” “believe,” “predict,” “potential” or “continue” or the negatives thereof or variations thereon or similar terminology. All statements other than statements of historical fact included in this press release are forward-looking statements and are based on various underlying assumptions and expectations and are subject to known and unknown risks, uncertainties and assumptions, and may include projections of our future financial performance based on our growth strategies and anticipated trends in our business. These statements are only predictions based on our current expectations and projections about future events. There are important factors that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied in the forward-looking statements, including but not limited to the availability of capital to us and to our customers and changes in interest rates; the ability of our lessees and potential lessees to make lease payments to us; our ability to successfully negotiate flight equipment (which includes aircraft, engines and helicopters) purchases, sales and leases, to collect outstanding amounts due and to repossess flight equipment under defaulted leases, and to control costs and expenses; changes in the overall demand for commercial aviation leasing and aviation asset management services; the continued impacts of the Ukraine Conflict, including the resulting sanctions by the United States, the European Union, the United Kingdom and other countries, on our business and results of operations, financial condition and cash flows; the effects of terrorist attacks on the aviation industry and on our operations; the economic condition of the global airline and cargo industry and economic and political conditions; the impact of hostilities in the Middle East, or any escalation thereof, on the aviation industry or our business; development of increased government regulation, including travel restrictions, sanctions, regulation of trade and the imposition of import and export controls, tariffs and other trade barriers; a downgrade in any of our credit ratings; competitive pressures within the industry; regulatory changes affecting commercial flight equipment operators, flight equipment maintenance, engine standards, accounting standards and taxes; and disruptions and security breaches affecting our information systems or the information systems of our third-party providers.

As a result, we cannot assure you that the forward-looking statements included in this press release will prove to be accurate or correct. These and other important factors and risks are discussed in AerCap’s annual report on Form 20-F and other filings with the SEC. In light of these risks, uncertainties and assumptions, the future performance or events described in the forward-looking statements in this press release might not occur. Accordingly, you should not rely upon forward-looking statements as a prediction of actual results and we do not assume any responsibility for the accuracy or completeness of any of these forward-looking statements. Except as required by applicable law, we do not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

 

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SOURCE AerCap Holdings N.V.

Neurocrine Biosciences Appoints Dr. Sanjay Keswani as Chief Medical Officer

PR Newswire

  • Accomplished physician-scientist brings more than 20 years of industry leadership experience and broad R&D expertise in multiple therapeutic areas 


SAN DIEGO
, April 4, 2025 /PRNewswire/ — Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the appointment of Sanjay Keswani, M.D., to the company’s executive management team as Chief Medical Officer (CMO) effective June 2, 2025. Dr. Keswani, an accomplished physician-scientist who has more than 20 years of pharmaceutical industry experience with broad R&D expertise in multiple therapeutic areas, will lead the clinical development and medical affairs activities at Neurocrine. Dr. Keswani succeeds Eiry W. Roberts, M.D., who has served as CMO for the past seven years and who will remain with Neurocrine in a strategic advisory role.

“Sanjay brings a wealth of strategic and development expertise to our team, enhancing our capabilities as we enter an exciting and pivotal time for the company,” said Kyle W. Gano, Ph.D., Chief Executive Officer, Neurocrine Biosciences. “His contributions will extend our reach beyond small molecule medicines, enabling us to explore new modalities across our therapeutic areas of focus.”

“I am thrilled to be joining Neurocrine at this stage of the company’s evolution. I am drawn by Neurocrine’s enduring R&D commitment to developing much-needed treatments for patients using a rigorous scientific approach involving diverse modalities, including small molecule, peptide, antibody and gene therapy,” Dr. Keswani said.

Dr. Keswani has more than two decades of executive leadership experience across both large pharmaceutical companies and small biotechnology firms – and was instrumental in the development of several first-in-class and best-in-class approved medicines. Before joining Neurocrine, he was the President and Chief Executive Officer of ImmunoBrain, a clinical-stage biotechnology firm focused on developing therapeutics that leverage endogenous neuroimmune communication to promote brain repair in patients with neurodegenerative diseases. Dr. Keswani will continue to serve on ImmunoBrain’s board of directors. Before that, he was Senior Vice President and R&D Head for Neuroscience, Ophthalmology and Rare Diseases at Hoffman La Roche. Earlier, he was Vice President of Exploratory and Clinical Translational Research at Bristol-Myers Squibb, where he was responsible for multiple therapeutic areas, including immunology, neuroscience, rare diseases, fibrosis and virology.

Dr. Keswani is an elected Fellow of the Royal College of Physicians, United Kingdom, and a former Neurology Faculty member at The Johns Hopkins Hospital, where he cared for patients with diverse neurological conditions and ran an RO1-funded Neuroimmunology research laboratory, focused on discovering treatments for neurodegeneration. He graduated with honors at St. Bartholomew’s Hospital and holds a First-Class honors BSc degree from St. Mary’s Hospital, London in Pathology & Basic Medical Sciences (Immunology). He completed his residency in Neurology and fellowships in Neuroimmunology and Neurophysiology at The Johns Hopkins Hospital.

During her tenure, Dr. Roberts led indication expansion efforts for INGREZZA® (valbenazine) capsules and the crinecerfont development program that led to U.S. Food and Drug Administration approval of CRENESSITY™ (crinecerfont). She also was responsible for the recent successful Phase 2 proof of concept studies for osavampator and NBI-1117568, both of which are moving into registrational programs this year.

“Since joining Neurocrine in 2018, Eiry has made enormous positive contributions that helped us become the company we are today,” Dr. Gano said. “She built an outstanding clinical development team and broadened our internal capabilities, which are now a competitive advantage. We are grateful to continue benefiting from her experience and expertise as she transitions into a strategic advisory role for the company.”

About Neurocrine Biosciences

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X, and Facebook. (*in collaboration with AbbVie)

NEUROCRINE, the NEUROCRINE BIOSCIENCES Logo, YOU DESERVE BRAVE SCIENCE, and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc. CRENESSITY is a trademark of Neurocrine Biosciences, Inc.

Forward Looking Statements

In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements regarding our ability to execute on the Company’s clinical development plans, including investigating new modalities in neurology and immunology, and the contributions Dr. Keswani may make in his role with the Company. Factors that could cause actual results to differ materially from those stated or implied in the forward-looking statements include, but are not limited to, the following: the risk that the Company may not complete the leadership transition within currently anticipated timelines or at all; challenges that the Company may encounter in implementing the leadership transition; risks and uncertainties associated with Neurocrine Biosciences’ business and finances in general, risks and uncertainties associated with the commercialization of INGREZZA and CRENESSITY; risks related to the development of our product candidates; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with government and third-party regulatory and/or policy efforts which may, among other things, impose sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products; risks associated with competition from other therapies or products, including potential generic entrants for our products; and other risks described in our periodic reports filed with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2024. Neurocrine Biosciences disclaims any obligation to update the statements contained in this presentation after the date hereof other than as required by law.

 © 2025 Neurocrine Biosciences, Inc. All Rights Reserved. 04/2025 

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SOURCE Neurocrine Biosciences, Inc.

Hudbay Files Early Warning Report for American Copper Development Corporation

TORONTO, April 04, 2025 (GLOBE NEWSWIRE) — Hudbay Minerals Inc. (“Hudbay” or the “Company”) (TSX, NYSE: HBM) today announced that the Company has sold 1,000,000 common shares (the “Common Shares”) of American Copper Development Corporation (“American Copper”) at a price of C$0.1607 per Common Share for aggregate consideration of C$160,710 (the “Transaction”) and has filed an early warning report in respect of the Transaction.

Immediately prior to the Transaction, Hudbay held 1,979,319 Common Shares of American Copper, which represented approximately 10.7% of American Copper’s currently issued and outstanding Common Shares. Following closing of the Transaction, Hudbay will own 979,319 Common Shares, which represents approximately 5.3% of American Copper’s currently issued and outstanding Common Shares.

This news release is issued pursuant to applicable Canadian securities laws, including the requirements of National Instrument 62-103 – The Early Warning System and Related Take-Over Bid and Insider Reporting Issues. A copy of the corresponding early warning report will be filed and be available on American Copper’s profile on SEDAR+ at www.sedarplus.ca. The head office of American Copper is located at 710-1030 West Georgia Street, Vancouver, British Columbia, V6E 2Y3. The head office of Hudbay is located at 25 York Street, Suite 800, Toronto, Ontario, M5J 2V5.

Forward-Looking Information

This news release contains “forward-looking statements” and “forward-looking information” (collectively, “forward-looking information”) within the meaning of applicable Canadian and United States securities legislation. Forward- looking information includes information that relates to, among other things, statements with respect to the disposition of American Copper Common Shares. Forward-looking information is not, and cannot be, a guarantee of future results or events.

Forward-looking information is based on, among other things, opinions, assumptions, estimates and analyses that, while considered reasonable by Hudbay at the date the forward-looking information is provided, inherently are subject to significant risks, uncertainties, contingencies and other factors that may cause actual results and events to be materially different from those expressed or implied by the forward-looking information. Should one or more risk, uncertainty, contingency or other factor materialize or should any factor or assumption prove incorrect, actual results could vary materially from those expressed or implied in the forward-looking information. Hudbay does not assume any obligation to update or revise any forward-looking information after the date of this news release or to explain any material difference between subsequent actual events and any forward-looking information, except as required by applicable law.

About Hudbay

Hudbay (TSX, NYSE: HBM) is a copper-focused critical minerals company with three long-life operations and a world-class pipeline of copper growth projects in tier-one mining jurisdictions of Canada, Peru and the United States.

Hudbay’s operating portfolio includes the Constancia mine in Cusco (Peru), the Snow Lake operations in Manitoba (Canada) and the Copper Mountain mine in British Columbia (Canada). Copper is the primary metal produced by the company, which is complemented by meaningful gold production and by-product zinc, silver and molybdenum. Hudbay’s growth pipeline includes the Copper World project in Arizona (United States), the Mason project in Nevada (United States), the Llaguen project in La Libertad (Peru) and several expansion and exploration opportunities near its existing operations.

The value Hudbay creates and the impact it has is embodied in its purpose statement: “We care about our people, our communities and our planet. Hudbay provides the metals the world needs. We work sustainably, transform lives and create better futures for communities.” Hudbay’s mission is to create sustainable value and strong returns by leveraging its core strengths in community relations, focused exploration, mine development and efficient operations.

For further information, please contact:

Candace Brûlé
Vice President, Investor Relations, Financial Analysis and External Communications
(416) 814-4387
[email protected]



Taysha Gene Therapies Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

DALLAS, April 04, 2025 (GLOBE NEWSWIRE) — Taysha Gene Therapies, Inc. (Nasdaq: TSHA) (Taysha or the Company), a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system (CNS), today announced that, on April 1, 2025, the Compensation Committee of Taysha’s Board of Directors granted five new employees, in the aggregate, options to purchase 822,000 shares of the Company’s common stock in connection with their employment. The stock options were granted under the Taysha Gene Therapies, Inc. 2023 Inducement Plan as an inducement material to the individuals entering employment with Taysha in accordance with Nasdaq Listing Rule 5635(c)(4).

The stock options have an exercise price of $1.265 which is equal to the closing price of Taysha’s common stock on the date of grant. The stock option has a 10-year term and will vest over four years, with 25% of the option vesting on the first anniversary of the vesting commencement date and the remaining 75% of the option vesting in equal monthly installments over the 36 months thereafter. Vesting of the stock option is subject to such employee’s continued service to Taysha on each vesting date.

About Taysha Gene Therapies

Taysha Gene Therapies (Nasdaq: TSHA) is a clinical-stage biotechnology company focused on advancing adeno-associated virus (AAV)-based gene therapies for severe monogenic diseases of the central nervous system. Its lead clinical program TSHA-102 is in development for Rett syndrome, a rare neurodevelopmental disorder with no approved disease-modifying therapies that address the genetic root cause of the disease. With a singular focus on developing transformative medicines, Taysha aims to address severe unmet medical needs and dramatically improve the lives of patients and their caregivers. The Company’s management team has proven experience in gene therapy development and commercialization. Taysha leverages this experience, its manufacturing process and a clinically and commercially proven AAV9 capsid in an effort to rapidly translate treatments from bench to bedside. For more information, please visit http://www.tayshagtx.com.

Company Contact:

Hayleigh Collins
Senior Director, Corporate Communications and Investor Relations
Taysha Gene Therapies, Inc.
[email protected]

Media Contact:

Carolyn Hawley
Inizio Evoke
[email protected]



FOREWARN to Provide Identity Verification Services to Little Rock REALTORS® Association to Promote Agent Safety

The 2nd largest local REALTOR® Association in the state of Arkansas contracts to make FOREWARN services available for its 1,400+ real estate professional members to promote proactive agent safety

BOCA RATON, Fla., April 04, 2025 (GLOBE NEWSWIRE) — FOREWARN, LLC, a red violet company (NASDAQ: RDVT) and the leading provider of real-time information solutions for real estate agents, today announced that Little Rock REALTORS® Association (“LRRA”) will offer FOREWARN® services to its 1,400+ members it serves throughout the Little Rock metropolitan area to promote proactive real estate agent safety.

Available both online and through a mobile application, FOREWARN analyzes billions of data points and provides users with the ability to mitigate risks by verifying identity, searching for criminal histories, and validating information provided by potential clients — using just a phone number. FOREWARN allows agents to properly and safely plan for showings with a higher level of confidence.

The FOREWARN services offered by LRRA are available to the 1,400+ members at no additional cost to individual agents.

“It’s exciting that my home Association has made this investment into the safety of our members,” stated Carl Carter, a Little Rock REALTORS® Association member. “As a community still shaken by the tragic loss of my mom, Beverly Carter, providing access to FOREWARN further empowers agents to conduct their business in the safest way possible. I’ve been a FOREWARN user for several years now and have seen firsthand its transformative impact on how agents conduct their business and reinforcing the importance of consistent, informed workflows. As I’ve traveled the country speaking on agent safety, I’ve heard many stories from agents expressing gratitude for FOREWARN providing information they believe helped keep them safe. I’m so thankful the Little Rock REALTOR Association has brought this amazing resource to our agent family.”

Stacy Hamilton, CEO of Little Rock REALTORS® Association, added “Our top priority is ensuring the safety and success of our members by providing them with the most effective tools available. With the ever-present risks in the industry, providing FOREWARN was a clear choice. Having instant access to advanced identity verification empowers our members to make informed decisions, enhancing both their security and confidence in every interaction.”

Existing LRRA members will receive specific instructions on how to move forward with activating their FOREWARN subscription as an included benefit.

All other real estate agencies, agents, and appraisers can learn more about FOREWARN at www.forewarn.com.

About FOREWARN®

At FOREWARN, we bring instant knowledge through innovative solutions to ensure safer engagements and smarter interactions. Leveraging powerful analytics and a massive data repository, our solutions enable organizations to gain real-time knowledge, for purposes such as verifying identity, searching for criminal histories, and validating information. Risk assessment and due diligence at your fingertips™.

RELATED LINKS:

www.forewarn.com

About red violet®

At red violet, we build proprietary technologies and apply analytical capabilities to deliver identity intelligence. Our technology powers critical solutions, which empower organizations to operate with confidence. Our solutions enable the real-time identification and location of people, businesses, assets and their interrelationships. These solutions are used for purposes including identity verification, risk mitigation, due diligence, fraud detection and prevention, regulatory compliance, and customer acquisition. Our intelligent platform, CORE™, is purpose-built for the enterprise, yet flexible enough for organizations of all sizes, bringing clarity to massive datasets by transforming data into intelligence. Our solutions are used today to enable frictionless commerce, to ensure safety, and to reduce fraud and the concomitant expense borne by society. For more information, please visit www.redviolet.com.

FORWARD-LOOKING STATEMENTS

This press release contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipate,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning. Such forward looking statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations, including whether FOREWARN will address critical safety and security areas for Little Rock REALTORS® Association members and whether FOREWARN will give Little Rock REALTORS® Association members to make informed decisions, enhancing both their security and confidence in every interaction. Readers are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release and are advised to consider the factors listed above together with the additional factors under the heading “Forward-Looking Statements” and “Risk Factors” in red violet’s SEC Filings. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Investor Relations Contact:

Camilo Ramirez
Red Violet, Inc.
561-757-4500
[email protected]



Definitive Healthcare Corp. reports inducement grants under Nasdaq Listing Rule 5635(c)(4)

FRAMINGHAM, Mass., April 04, 2025 (GLOBE NEWSWIRE) — Definitive Healthcare (Nasdaq: DH), an industry leader in healthcare commercial intelligence, today announced that in connection with the hiring of one senior leader, the Human Capital Management and Compensation Committee (the “Committee”) of Definitive Healthcare’s Board of Directors granted inducement awards. The Committee granted Jeff Moyer, Definitive Healthcare’s new SVP of Growth and Sales Operations, an inducement award consisting of 364,432 time-based restricted stock units (“RSUs”), effective April 3, 2025. These awards were individually negotiated and granted as an inducement material to Mr. Moyer’s respective commencement of employment with Definitive Healthcare in accordance with Nasdaq Listing Rule 5635(c)(4).

Each of the awards is subject to the terms and conditions of Definitive Healthcare’s 2023 Inducement Plan (the “Plan”) and the terms and conditions of an applicable award agreement covering the grant.

Mr. Moyer’s RSUs will vest as follows, subject to Mr. Moyer’s continued employment through each such date: (i) 25% will vest on April 1, 2026; (ii) the remainder will vest in quarterly installments equal to 6.25% of the total RSUs over the subsequent 3 years, until fully vested.

About Definitive Healthcare

At Definitive Healthcare, our passion is to transform data, analytics, and expertise into healthcare commercial intelligence. We help clients uncover the right markets, opportunities, and people, so they can shape tomorrow’s healthcare industry. Our SaaS platform creates new paths to commercial success in the healthcare market, so companies can identify where to go next. Learn more at definitivehc.com.

Investor Contact:

Brian Denyeau
ICR for Definitive Healthcare
[email protected]
646-277-1251

Media Contact:

Bethany Swackhamer
[email protected]