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WINREVAIR demonstrated a statistically significant and clinically meaningful reduction in the primary endpoint of pulmonary vascular resistance (PVR) compared to placebo, improving the ability of blood to transition through the lungs to the heart
These data support proof-of-concept to inform Phase 3 development for WINREVAIR in this population
Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 2 CADENCE study evaluating WINREVAIR™ (sotatercept-csrk) in adults for the treatment of combined post- and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF). CADENCE met its primary endpoint, showing a statistically significant and clinically meaningful reduction in pulmonary vascular resistance (PVR) from baseline at 24 weeks compared to placebo. Based on a preliminary assessment, the safety profile observed in the CADENCE study was generally consistent with the known safety profile for WINREVAIR.
The company is planning to present these results at a future scientific congress and intends to proceed with Phase 3 development.
WINREVAIR is U.S. Food and Drug Administration (FDA) approved as an activin signaling inhibitor indicated for the treatment of adults with pulmonary arterial hypertension (PAH, WHO* Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death. WINREVAIR is currently approved in more than 50 countries.
Posted In: MRK
