Merck & (MRK) Stock News

Merck (NYSE:MRK) announced that the FDA has granted priority review for WINREVAIR's supplemental Biologics License Application (sBLA). The review aims to update the product label based on the Phase 3 ZENITH trial results, with a PDUFA date set for October 25, 2025.

The ZENITH trial demonstrated remarkable efficacy, showing a 76% reduction in the risk of composite events including death, lung transplantation, and PAH hospitalization compared to placebo. The trial was notably stopped early due to overwhelming efficacy, marking the first PAH Phase 3 outcome study focused entirely on major morbidity and mortality events.

WINREVAIR, currently approved in over 45 countries, is used to treat adults with pulmonary arterial hypertension (PAH) to improve exercise capacity, WHO functional class, and reduce clinical worsening events.

Merck (NYSE: MRK) has scheduled its second-quarter 2025 sales and earnings conference call for Tuesday, July 29, at 9:00 a.m. ET. During the call, company executives will present an overview of Merck's Q2 2025 performance to institutional investors and analysts.

The call will be accessible through a live audio webcast, with dial-in options available for participants at (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 using access code 9818590. Following the call, a replay of the webcast, sales and earnings release, supplemental financial disclosures, and presentation slides will be made available on Merck's website.

Merck (NYSE: MRK) announced that the CDC's Advisory Committee on Immunization Practices (ACIP) has recommended ENFLONSIA™ for preventing RSV lower respiratory tract disease in infants under 8 months of age. ENFLONSIA, recently FDA-approved, is the first and only RSV preventive option using the same dose regardless of infant weight.

The preventive monoclonal antibody provides protection through 5 months, covering a typical RSV season. Notably, ENFLONSIA has been included in the Vaccines for Children Program, enhancing accessibility. Merck plans to begin taking orders in July 2025, with deliveries scheduled before the 2025-2026 RSV season.

Merck (NYSE:MRK) has announced a virtual investor event scheduled for July 17, 2025, at 9:00 a.m. ET. During this event, the company's scientific and commercial team leaders will present an overview of Merck's advancing research pipeline focused on HIV treatment and prevention.

The presentation will be accessible via webcast to investors, analysts, media representatives, and the general public. Institutional investors and analysts will have the opportunity to participate in a Q&A session by dialing in using the provided information.

Merck announced positive Phase 3 HYPERION trial results for WINREVAIR (sotatercept-csrk) in recently diagnosed adults with pulmonary arterial hypertension (PAH). The study met its primary endpoint, demonstrating a significant reduction in clinical worsening events compared to placebo. The trial included patients with WHO Group 1 PAH, with 72.2% on double therapy within 12 months of initial diagnosis. HYPERION marks the third successful Phase 3 study for WINREVAIR, following STELLAR and ZENITH trials. The study was stopped early due to positive interim results, and patients were offered continued treatment through the SOTERIA open-label extension study. WINREVAIR, a first-in-class activin signaling inhibitor, is currently approved in over 45 countries based on STELLAR study results.

Merck (MRK) and Daiichi Sankyo have initiated the IDeate-Prostate01 phase 3 trial for ifinatamab deruxtecan (I-DXd), a potential first-in-class B7-H3 directed antibody drug conjugate, in patients with metastatic castration-resistant prostate cancer (mCRPC). The trial will evaluate I-DXd against docetaxel in patients whose disease progressed during or after androgen receptor pathway inhibitor treatment. This marks the third pivotal trial in the I-DXd development program. The decision follows promising results from the IDeate-PanTumor01 phase 1/2 trial presented at ESMO 2022 and 2023. The development addresses a significant medical need, as advanced prostate cancer's five-year survival rate drops to 31%, compared to 90% for localized cases.

Merck announced FDA approval of KEYTRUDA (pembrolizumab) for treating resectable locally advanced head and neck squamous cell carcinoma (HNSCC) with PD-L1 expression. This marks the first perioperative anti-PD-1 treatment regimen for this condition. Based on the Phase 3 KEYNOTE-689 trial, KEYTRUDA showed significant efficacy, reducing the risk of event-free survival events by 30% compared to standard care. The median EFS was 59.7 months for KEYTRUDA versus 29.6 months for standard care. The approval introduces a new treatment paradigm where KEYTRUDA is used before surgery (neoadjuvant), after surgery with radiotherapy/cisplatin (adjuvant), and then as a single agent. The drug demonstrated a manageable safety profile, though immune-mediated adverse reactions can occur. This approval was reviewed under Project Orbis, with applications under review globally.

Merck Animal Health (NYSE:MRK) has received a positive opinion from the European Medicines Agency's CVMP for NUMELVI (atinvicitinib) Tablets for Dogs. NUMELVI is set to become the first and only second-generation JAK inhibitor for treating pruritus associated with allergic dermatitis and atopic dermatitis in dogs. The once-daily treatment is at least 10-fold more selective for JAK1 compared to other JAK family members, offering a superior safety profile while maintaining efficacy. Notable features include its use in dogs as young as six months old, effectiveness from the first dose, and no impact on vaccination immune response. The treatment addresses a significant market, as itch affects over 20% of dogs in general veterinary practice. European Commission's marketing authorization decision is expected in Q3 2025.

Merck (NYSE: MRK) has initiated MOBILIZE-1, its first Phase 3 clinical trial for V181, a novel quadrivalent dengue vaccine candidate. The study aims to evaluate the safety, immunogenicity, and efficacy of a single-dose vaccine designed to prevent dengue disease caused by all four dengue virus serotypes, regardless of prior exposure. The trial has begun recruitment in Singapore, marking a significant milestone in addressing this widespread mosquito-borne disease that threatens approximately half of the world's population. V181 could potentially offer a crucial single-dose preventive option for at-risk populations globally. Merck plans to conduct trials in various regions where dengue poses a significant health threat.