Trump announces trade deal with EU following months of negotiations
RAHWAY, N.J. - Merck (NSE:PROR) (NYSE: MRK), a prominent player in the pharmaceuticals industry with $63.9 billion in annual revenue and robust 77% gross margins, announced Monday that its WINREVAIR demonstrated a significant reduction in clinical worsening events for recently diagnosed pulmonary arterial hypertension (PAH) patients, according to topline results from the Phase 3 HYPERION study.
The study evaluated WINREVAIR (sotatercept-csrk) versus placebo in adults diagnosed with PAH within the previous 12 months who were already on background therapy. Over 72% of participants were receiving double therapy at the time of enrollment. According to InvestingPro data, analysts maintain a bullish outlook on Merck, with the stock currently trading below its Fair Value, suggesting potential upside from this and other pipeline developments.
HYPERION met its primary endpoint of time to clinical worsening, measured by a composite of events including death, PAH-related hospitalization, atrial septostomy, lung transplantation, or disease deterioration.
The trial was stopped early based on positive results from another study in the WINREVAIR clinical program and a review of available data. Participants were offered the opportunity to receive WINREVAIR through an open-label extension study.
"These positive results from HYPERION expand on the body of clinical evidence now including recently diagnosed adults," said Dr. Joerg Koglin, senior vice president at Merck Research Laboratories, in the press release statement.
The study enrolled 320 participants who were randomized to receive either WINREVAIR or placebo in addition to their background therapy. Most patients (78.8%) were classified as functional class III, with the remainder (21.3%) in class II.
WINREVAIR is the first activin signaling inhibitor approved for PAH treatment. The drug is currently approved in more than 45 countries based on results from a previous Phase 3 study called STELLAR.
Common adverse reactions reported in previous clinical trials included headache, nosebleeds, rash, and dizziness. The safety profile in HYPERION was generally consistent with previous studies, according to the company.
PAH is a rare, progressive disorder characterized by constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation, affecting approximately 40,000 people in the U.S.
Detailed results from the HYPERION study will be presented at an upcoming medical meeting and submitted to regulatory authorities.
In other recent news, Merck has received FDA approval for its Keytruda treatment, designed for adult patients with resectable locally advanced head and neck squamous cell carcinoma. This makes Keytruda the first perioperative anti-PD-1 treatment regimen for this patient group, showing a 30% reduction in event-free survival events compared to the standard of care. Additionally, Merck Animal Health announced a positive opinion from the European Medicines Agency for Numelvi, a treatment for canine allergic dermatitis, which could become the first second-generation JAK inhibitor for dogs if approved. Meanwhile, Merck has initiated a Phase 3 clinical trial for its dengue vaccine candidate, V181, aimed at preventing dengue disease in children aged 2 to 17 years. The study will involve approximately 12,000 participants across multiple countries in the Asia-Pacific region. This trial marks a significant step in Merck’s dengue vaccine development program, focusing on safety, immunogenicity, and efficacy. These developments highlight Merck’s ongoing efforts in advancing treatments across various medical fields.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.