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The Global Revolution in Healthcare Driven by GLP-1 Drugs and the role of Lexaria Bioscience

The Global Revolution in Healthcare Driven by GLP-1 Drugs and the role of Lexaria Bioscience

Lexaria executing a triple-pronged strategy in obesity and diabetes
Semaglutide recently approved to treat chronic kidney disease
KELOWNA, BC / ACCESS Newswire / February 27, 2025 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the 'Company' or 'Lexaria'), a global innovator in drug delivery platforms, provides the following glucagon-like peptide-1 ('GLP-1") strategic update.
Lexaria is rapidly executing its multi-faceted strategy centered around its proprietary DehydraTECH processing technology. Our main goal is to attract pharmaceutical companies seeking the benefits of adopting Lexaria's technology for use with their own existing drug products. This first prong of our strategy has been evidenced and validated by the Company's entry in a material transfer agreement with a pharmaceutical company which was announced in September of 2024. Lexaria continues to collaborate with its pharmaceutical partner on examining the impact of DehydraTECH processing.
In the second prong of our strategy, the Company is examining the potential to develop and launch a patented DehydraTECH-CBD product within GLP-1. This could come in the form of a partnership with an existing player or Lexaria could potentially launch its own internally developed product(s). Lastly, in the third prong of our strategy, the Company is investigating the possibility of developing and selling the world's first oral version of a leading injectable GLP-1 drug, liraglutide, using DehydraTECH. As such, GLP-1 industry developments have the potential to dramatically affect Lexaria's strategy and future.
The GLP-1 industry is experiencing revolutionary advancements across multiple healthcare sectors. If there has ever been a class of drugs that could change the world - or is perhaps already changing the world - it would be GLP-1. As tens of millions of people around the world utilize these drugs in their pursuit of better health outcomes, there will of course be unwanted side effects and even negative health outcomes in some fraction of GLP-1 drug users. With that said, the benefits of these drugs overwhelmingly outweigh all of the currently known negative outcomes.
As we noted on , GLP-1 drugs are either approved for use, or are being investigated for use, in all of the following healthcare sectors:
Most recently, the Food and Drug Administration ('FDA') approved Ozempic ® (semaglutide) owned by Novo Nordisk®, to 'reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease ('CKD'). This has the potential to literally be a life-saver for some of the 37 million adults in America struggling with CKD, which, until now, often had NO CURE.
As we noted on November 7, 2024, growth expectations for the GLP-1 industry - prior to the FDA's approval of semaglutide for treatment of CKD - supported a growing consensus that revenue in the GLP-1 drug sector will soon be over $100 billion per year, with one sector revenue forecast at an astounding $471 billion per year.
Initial skepticism related to the sector's staying power has dissipated as positive healthcare results continue to build, and the industry continues its unprecedented expansion into additional use categories. With all this positivity, it seems that 'nothing could go wrong'. And yet, there are two inescapable challenges that continues to plague the industry: disliked injections and gastrointestinal adverse events.
Lexaria's DehydraTECH technology is designed to allow for effective oral dosing as opposed to the intensely disliked injected administration: 63% of participants in one study reported experiencing trypanophobia or needle phobia. As reported on August 27, 2024, Lexaria has already demonstrated in human testing, delivery superiority to the world's ONLY existing orally dosed GLP-1 drug, Rybelsus® (semaglutide), owned by Novo Nordisk®.
In addition, between 47% and 64% of GLP-1 users with type 2 diabetes, discontinue use of their GLP-1 drug within 1 or 2 years, respectively. " Gastrointestinal adverse events were linked to the discontinuation rates.'
As we reported on August 28, 2024 and January 14, 2025, DehydraTECH-GLP-1 processing has repeatedly shown its propensity to reduce side effects, including but not limited to gastrointestinal adverse events, in both of the major GLP-1 drugs currently available in the world today, being Eli Lilly's tirzepatide, and Novo Nordisk's® semaglutide. One of the only other GLP-1 drugs on the market today, liraglutide, will soon also be tested by Lexaria in humans utilizing DehydraTECH processing.
By enabling oral dosing choices to replace injections; and by reducing adverse events that seem to the be #1 reason that patients stop using GLP-1 drugs, Lexaria's DehydraTECH technology could be of vital importance to the future health of this burgeoning healthcare sector.
'Lexaria is the only company in the world that has demonstrated an ability to improve the drug delivery characteristics of the dominant GLP-1 drugs prescribed today, which are expected to generate over $30 billion in revenue in 2025,' said Richard Christopher, CEO of Lexaria. 'We continue to work at the fastest pace possible and make every attempt to assist the pharmaceutical industry in its investigations of our unique drug delivery platform technology, DehydraTECH, and encourage its adaptation into what is surely the most exciting healthcare sector of our time.'
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way a wide variety of drugs enter the bloodstream, always through oral delivery. DehydraTECH has repeatedly evidenced the ability to increase bio-absorption, reduce side-effects, and deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 48 patents granted and additional patents pending worldwide. For more information, please visit www.lexariabioscience.com.
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as 'anticipate,' 'if,' 'believe,' 'plan,' 'estimate,' 'expect,' 'intend,' 'may,' 'could,' 'should,' 'will,' and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
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Wallbox Announces Reverse Stock Split
Wallbox Announces Reverse Stock Split

Business Wire

time17 minutes ago

  • Business Wire

Wallbox Announces Reverse Stock Split

BARCELONA, Spain--(BUSINESS WIRE)--Wallbox (NYSE: WBX) today announced that it is expected to implement a 20-for-1 reverse stock split of all classes of the Company's ordinary shares. The reverse stock split is intended to bring the Company into compliance with the minimum bid price requirement set by the New York Stock Exchange ('NYSE'). Wallbox shareholders approved at the Company's Annual General Meeting held on June 30, 2025 ('AGM') a reverse stock split ratio within a range of 1-for-10 to 1-for-40 and authorized the Board of Directors to determine and execute the final ratio. The Company's Board of Directors subsequently approved the final reverse split ratio of 20-for-1 on the same date. Wallbox's ordinary class A shares ('Class A Shares') are expected to begin trading on a reverse split-adjusted basis at market open on July 3, 2025 under the existing trading symbol 'WBX' with a new CUSIP number N94209 124 ('Effective Date'). On the Effective Date, every 20 shares of Wallbox's issued and outstanding ordinary shares will be automatically combined into one ordinary share. The reverse stock split will affect all shareholders uniformly and will not affect any shareholder's percentage ownership interest in the Company (except to the extent that the reverse stock split would result in any of the shareholders owning a fractional interest). Shares held in registered form in the Company's shareholder register, or in the register maintained by the Company's U.S. transfer agent, Continental Stock Transfer & Trust Company, will be consolidated and converted on a split-adjusted basis. Any fractional shares resulting from the reverse split will be treated in accordance with the rights specified in the deed of amendment of the Company's articles of association to be executed prior to the Effective Date or such other instrument governing the right to the ordinary share. 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Additional information regarding the reverse stock split and other matters voted on at the AGM can be found in the Forms 6-K and exhibits thereto filed with the U.S. Securities and Exchange Commission on May 30, 2025 and July 2, 2025, and on Wallbox's Investor Relations website at About Wallbox Wallbox is a global technology company, dedicated to changing the way the world uses energy. Wallbox creates advanced electric vehicle charging and energy management systems that redefine the relationship between users and the network. Wallbox goes beyond charging electric vehicles to give users the power to control their consumption, save money and live more sustainably. Wallbox offers a complete portfolio of charging and energy management solutions for residential, semi-public, and public use in more than 100 countries around the world. Founded in 2015 in Barcelona, where the company's headquarters are located, Wallbox currently has offices across Europe, Asia, and America. 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Snowline Gold Discovers New RIRGS Target Near Its Valley Deposit and Provides 2025 Field Program Update
Snowline Gold Discovers New RIRGS Target Near Its Valley Deposit and Provides 2025 Field Program Update

Yahoo

time20 minutes ago

  • Yahoo

Snowline Gold Discovers New RIRGS Target Near Its Valley Deposit and Provides 2025 Field Program Update

New reduced-intrusion related gold system, "Celestic," discovered at surface roughly 27 km from Valley and 5 km from existing heavy equipment winter trail Discovery highlighted by selective grab samples of up to 11.7 g/t Au and an outcrop chip sample of 1.09 g/t Au over 4.0 m from zones of densely sheeted quartz veins exposed at surface Snowline's broader 2025 field program advancing ahead of schedule, with >11,000 m drilled to date on three targets alongside an expanded development-focused program to support future technical studies and permitting. VANCOUVER, BC / / July 2, 2025 / SNOWLINE GOLD CORP. (TSX-V:SGD)(OTCQB:SNWGF) (the " Company " or " Snowline ") is pleased to announce discovery of a reduced-intrusion related gold system ("RIRGS") on its Cynthia Project, Yukon, roughly 27 km southwest of its Valley gold deposit ("Valley") on the adjacent Rogue Project (Figures 2 & 3). The "Celestic" target covers several zones of gold-bearing, densely sheeted quartz veins exposed in a 4.5 x 3 km granodiorite intrusion. Selective grab samples of quartz vein material returned up to 11.7 g/t Au, while a continuous 4.0 m chip sample across an exposed outcrop returned 1.09 g/t Au (Figure 1). Subject to additional follow up, the Celestic target may see initial drilling in 2025 as Snowline advances its largest field program to date. "That we are still finding large, exposed, untested, and previously unknown reduced-intrusion related gold systems near our flagship Valley deposit highlights the underexplored nature of this prospective district," said Scott Berdahl, CEO & Director of Snowline. "I would like to commend Snowline's field teams for their ongoing work in advancing and expanding our pipeline of regional targets on our 100%-owned, 3,600 km 2 Yukon mineral claim position. We are excited by the demonstrated fertility of this region as we continue to uncover compelling new targets, and of course by the opportunity to test these targets for the very first time." 2025 FIELD PROGRAM UPDATE Drilling: Snowline's 2025 drill program is proceeding ahead of schedule, with five drills turning and over 11,000 m completed to date in 28 holes on three targets. Over 8,000 m of this drilling has been completed around Valley, primarily as step-outs sampling previously untested locations within the broader Valley intrusion and as infill drilling aimed at converting inferred mineral resources to indicated mineral resources or higher. Roughly 2,500 m has been completed at the Einarson Project's Jupiter target. An additional 500 m has been completed as part of a Phase I drill program on the Einarson Project's Neptune target, the first ever drill testing of a roughly 30 km zone of elevated to anomalous gold in talus fines and soils associated with a regional-scale faulted anticline. Subsequent regional drilling will focus primarily on RIRGS targets on the Rogue and Cynthia projects. Valley Development: Snowline has expanded the scope of its 2025 field program to support advancement of Valley towards a Prefeasibility Study and permitting. The expanded program includes: Surficial mapping, test pitting, sonic drilling and passive seismic surveying to characterize overburden around Valley and at potential infrastructure locations geotechnical drilling to improve understanding of pit constraints geochemical and metallurgical testing to inform processing refinements and reclamation considerations hydrometric monitoring and hydrogeological testing to further characterize surface and groundwater expanded wildlife surveying to inform permitting baselines, and LiDAR surveying across the broader project footprint to inform engineering work. CELESTIC TARGET, CYNTHIA PROPERTY The Celestic target is a newly discovered RIRGS with a Valley-type signature characterized by quartz-sheeted veins hosted within a 4.5 x 3 km multiphase granodioritic intrusive. The target covers at least five areas of densely sheeted quartz veins. It is located roughly 1 km and 3 km southwest of Snowline's "Intersection" and "Sydney" targets on its Cynthia Project, Yukon and 27 km southwest of Valley. The Plata winter trail, a potential future access route for Valley in the Rogue Project Preliminary Economic Assessment [1] , runs within 5 km of the target. Regional geochemical sampling shows elevated to anomalous gold and bismuth values in stream sediments across multiple drainages originating from the intrusion. Follow-up prospecting revealed multiple zones of sheeted quartz veins typical of RIRGS mineralization, including a 500 x 400 m area with vein densities >10/m, often with multiple orientations present. Initial results are considered by the Company to be encouraging; of 74 samples taken, 14 returned >0.1 g/t Au, averaging 1.4 g/t Au. Continuous sampling yielded channel samples of 4.0 meters at 1.09 g/t Au, together with selective samples of bismuthinite-bearing quartz vein material assaying up to 11.7 g/t Au. The sheeted vein corridor, characterized by gold-bismuth-tellurium-tungsten anomalies, is open in all directions. STOCK OPTIONS, DEFERRED SHARE UNITS AND RESTRICTED SHARE UNITS Snowline also announces that it has granted a total of 300,000 stock options, 60,000 Deferred Share Units ("DSUs"), and 150,000 Restricted Share Units ("RSUs") to certain employees and a director pursuant to its Omnibus Incentive Plan. The stock options have an exercise price of C$8.64, vest 20% each six months starting six months from the grant date and expire after five years. The RSUs vest 100% in three years from the grant date. The DSUs vest immediately upon grant and are payable upon the holder ceasing to be a director of the Company. ABOUT SNOWLINE GOLD CORP. Snowline Gold Corp. is a Yukon Territory focused gold exploration and development company with mineral claim portfolio covering roughly 360,000 ha (3,600 km 2 ). The Company is advancing its Valley gold deposit-a large, low-strip, near surface, >1 g/t Au bulk tonnage gold system located in the eastern Yukon-while continuing regional exploration of surrounding targets on the Rogue Project and the broader district in the highly prospective yet underexplored Selwyn Basin. Valley hosts an open mineral resource estimate of 7.94 million ounces gold at 1.21 g/t Au Measured and Indicated and an additional 0.89 million ounces gold Inferred at 0.62 g/t Au, as outlined in a May 15, 2025 news release [2] . Results of a preliminary economic analysis on Valley suggest the potential for the deposit to support a long-life mining operation with a strong production profile and low production costs, as outlined in a June 23, 2025 news release . Snowline's project portfolio sits within the prolific Tintina Gold Province, host to multiple million-ounce-plus gold mines and deposits across the central Yukon and Alaska. The Company's comprehensive first-mover position and extensive exploration database provide a distinct competitive advantage and a unique opportunity for investors to be part of multiple discoveries, the advancement of a significant gold deposit, and the creation of a new gold district. QUALIFIED PERSON Information in this release has been prepared under supervision of and approved by Sergio Gamonal, P. Geo., Chief Geologist for Snowline Gold Corp, as Qualified Person for the purposes of National Instrument 43-101. ON BEHALF OF THE BOARD Scott BerdahlCEO & Director For further information, please contact: Snowline Gold Corp.+1 778 650 5485info@ Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This news release contains certain forward-looking statements, including statements about the Company's work programs, results, surface work, advancement of studies and permitting, mineral resource estimates, projected mining plans costs, projected life of mine, and plans for exploring and expanding a new greenfield, district-scale gold system. Wherever possible, words such as "may", "will", "should", "could", "expect", "plan", "intend", "anticipate", "believe", "estimate", "predict" or "potential" or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. These statements reflect management's current beliefs and are based on information currently available to management as at the date hereof. Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. Such factors include, among other things: risks related to uncertainties inherent in drill results and the estimation of mineral resources; and risks associated with executing the Company's plans and intentions. These factors should be considered carefully, and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this news release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this news release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law. [1] See news release dated June 23, 2025 available under the Company's profile at and on the Company's website at [2] Mineral resources are not mineral reserves and do not have demonstrated economic viability. The estimate of mineral resources may be materially affected by metal prices, economic factors, environmental, permitting, legal, title, or other relevant issues. The mineral resource estimate has a cut-off grade of 0.30 g/t gold. SOURCE: Snowline Gold Corp. View the original press release on ACCESS Newswire Sign in to access your portfolio

FDA Grants Priority Review for WINREVAIR™ (sotatercept-csrk) to Update Label Based on Results From ZENITH Trial
FDA Grants Priority Review for WINREVAIR™ (sotatercept-csrk) to Update Label Based on Results From ZENITH Trial

Business Wire

time22 minutes ago

  • Business Wire

FDA Grants Priority Review for WINREVAIR™ (sotatercept-csrk) to Update Label Based on Results From ZENITH Trial

RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval to update the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR™ (sotatercept-csrk). In 2024, WINREVAIR was approved for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 PH) to increase exercise capacity, improve WHO* functional class (FC), and reduce the risk of clinical worsening events. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of Oct. 25, 2025. The sBLA is based on data from the Phase 3 ZENITH trial. The ZENITH trial was the first PAH Phase 3 outcome study to use a primary endpoint comprised entirely of major morbidity and mortality events. It was also the first PAH Phase 3 study stopped early by an independent data monitoring committee for overwhelming efficacy. In ZENITH, WINREVAIR demonstrated a 76% reduction in the risk of a composite of all-cause death, lung transplantation, and hospitalization for PAH ≥24 hours compared to placebo. Improvement was observed early in treatment with increasing benefit throughout the study. The safety profile of WINREVAIR in ZENITH was generally consistent with that observed in previous studies. These results were published in the New England Journal of Medicine. 'We are pleased that the FDA has accepted our sBLA for WINREVAIR and granted a priority review to consider an update to labeling for WINREVAIR to include the impressive results of ZENITH. There remains a significant unmet medical need for patients living with PAH who, despite being on background therapy, remain at higher risk of morbidity and mortality,' said Dr. Joerg Koglin, senior vice president, global clinical development, Merck Research Laboratories. 'The FDA's Priority Review designation acceptance of our sBLA reinforces our confidence in WINREVAIR for a broad range of patients and represents a critical step toward advancing the treatment of PAH.' WINREVAIR is currently approved in more than 45 countries based on the results from the STELLAR trial. *World Health Organization About ZENITH The ZENITH study (NCT04896008) is a global, double-blind, placebo-controlled clinical trial to evaluate WINREVAIR when added to maximum tolerated background PAH therapy on time to first event of all-cause death, lung transplantation, or PAH worsening related hospitalization of ≥ 24 hours, in adult participants with WHO functional class III or IV PAH at high risk of mortality. ZENITH study inclusion criteria required Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) Lite 2.0 risk score of ≥9. The study enrolled 172 participants, who were randomized in a 1:1 ratio to either WINREVAIR plus background PAH therapy or placebo plus background PAH therapy. The primary composite outcome measure was time to first confirmed major morbidity or mortality event. Events were defined as all-cause death, lung transplantation, or PAH worsening-related hospitalization of ≥ 24 hours. Secondary outcome measures included overall survival, transplant-free survival and several additional measures. The study excluded patients with PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension as well as diagnosis of pulmonary veno-occlusive diseases, pulmonary capillary hemangiomatosis or overt signs of capillary and/or venous involvement. Participants who completed the ZENITH trial were offered the opportunity to receive WINREVAIR as part of the open-label, long-term extension study, SOTERIA (NCT04796337), consistent with that study's eligibility criteria. About WINREVAIR ™ (sotatercept-csrk) for injection, for subcutaneous use, 45 mg, 60 mg WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events. WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, WINREVAIR induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics. WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb. Selected Safety Information for WINREVAIR in the U.S. WINREVAIR may increase hemoglobin (Hgb). Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required. WINREVAIR may decrease platelet count. Severe thrombocytopenia may increase the risk of bleeding. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm 3. Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required. In clinical studies, serious bleeding (eg, gastrointestinal, intracranial hemorrhage) was reported in 4% of patients taking WINREVAIR and 1% of patients taking placebo. Patients with serious bleeding were more likely to be on prostacyclin background therapy and/or antithrombotic agents, or have low platelet counts. Advise patients about signs and symptoms of blood loss. Do not administer WINREVAIR if the patient is experiencing serious bleeding. WINREVAIR may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting WINREVAIR treatment. Based on findings in animals, WINREVAIR may impair female and male fertility. Advise patients on the potential effects on fertility. The most common adverse reactions occurring in the phase 3 clinical trial (≥10% for WINREVAIR and at least 5% more than placebo) were headache (24.5% vs 17.5%), epistaxis (22.1% vs 1.9%), rash (20.2% vs 8.1%), telangiectasia (16.6% vs 4.4%), diarrhea (15.3% vs 10.0%), dizziness (14.7% vs 6.2%), and erythema (13.5% vs 3.1%). Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose. About PAH Pulmonary arterial hypertension (PAH) is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. Approximately 40,000 people in the U.S. are living with PAH. The disease progresses rapidly for many patients. PAH results in significant strain on the heart, leading to limited physical activity, heart failure and reduced life expectancy. The five-year mortality rate for patients with PAH is approximately 43%. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the 'company') includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2024 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( Patient Information for WINREVAIR at , and Instructions for Use for WINREVAIR (1-vial kit, 2-vial kit) at

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