Tag: Merck

Merck Announces Decision to Stop Phase 3 HYPERION Trial Evaluating WINREVAIR™ (sotatercept-csrk) Early and Move to Final Analysis

Robust evidence of the clinical benefit of WINREVAIR demonstrated in the STELLAR and ZENITH studies resulted in a loss of clinical equipoise in the HYPERION study January 30, 2025 06:45 AM Eastern Standard Time RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced […]

Merck Receives European Commission Approval for WINREVAIR™ (sotatercept) in Combination With Other Pulmonary Arterial Hypertension (PAH) Therapies, for the Treatment of PAH in Adult Patients With Functional Class II-III

WINREVAIR is the first activin signaling inhibitor therapy for PAH approved in Europe RAHWAY, N.J.–(BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the European Commission (EC) has approved WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the […]

Merck Receives Positive EU CHMP Opinion for WINREVAIR™ (sotatercept) in Pulmonary Arterial Hypertension (PAH)

If approved by the European Commission, WINREVAIR will be the first activin signaling inhibitor therapy for PAH in Europe, offering a new treatment option for certain adults with this rare, progressive disease Milestone highlights Merck’s focus on global filings to expand access to WINREVAIR and commitment to patients living with […]

Merck Receives Priority Review from FDA for New Biologics License Application for Sotatercept, an Activin Signaling Inhibitor to Treat Adults with Pulmonary Arterial Hypertension (PAH)

RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review a new Biologics License Application (BLA) for sotatercept, Merck’s novel investigational activin signaling inhibitor, for the treatment of adult patients […]

Merck Presents New Analyses Supporting the Promising Potential of Sotatercept, its Investigational Medicine for Adults with Pulmonary Arterial Hypertension (PAH)

Exploratory post-hoc analysis of STELLAR shows potential of sotatercept to improve cardiovascular function Interim results from SOTERIA open-label extension study represent longest safety and efficacy analysis of sotatercept to date; safety profile of sotatercept consistent with previous studies and efficacy improvements maintained after one year of therapy Nine Merck-sponsored abstracts […]

Merck’s MK-0616, an Investigational Oral PCSK9 Inhibitor, Significantly Reduced LDL-C in Patients with Hypercholesterolemia in Phase 2b Study

MK-0616 was generally well tolerated and reduced LDL-C across all dose levels compared to placebo Merck plans to start Phase 3 pivotal study in the second half of 2023 RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase […]

Merck Receives Fast Track Designation from the U.S. FDA for MK-2060, an Investigational Anticoagulant Therapy

Phase 2 Study of MK-2060 Currently Ongoing in People with End-Stage Renal Disease Receiving Hemodialysis RAHWAY, N.J.–(BUSINESS WIRE)– Merck, (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Merck’s investigational anticoagulant therapy […]

Merck Announces Fourth-Quarter and Full-Year 2021 Financial Results

Fourth-Quarter and Full-Year Results Reflect Continued Strong Business Momentum and Operational Strength Fourth-Quarter 2021 Worldwide Sales From Continuing Operations Were $13.5 Billion, an Increase of 24% From Fourth-Quarter 2020; Excluding the Impact From Foreign Exchange, Sales Grew 23%; Includes $952 Million of Molnupiravir Sales Fourth-Quarter 2021 GAAP EPS From Continuing […]