FDA Grants Priority Review for Merck & Co’s (MRK) WINREVAIR

Merck & Co., Inc. (NYSE:MRK) is one of the 10 Best Dip Stocks to Buy According to Billionaires. On July 2, Merck & Co., Inc. (NYSE:MRK) announced that the FDA has accepted and granted priority review to its supplemental Biologics License Application for WINREVAIR.

Merck & Co., Inc.’s (NYSE:MRK) WINREVAIR was previously approved in 2024 for treating adults with pulmonary arterial hypertension. The treatment aims to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events. The current application seeks to update the US product label based on the results of the Phase 3 ZENITH trial.

A close-up of a person’s hand holding a bottle of pharmaceuticals.

The ZENITH trial is notable for being the first Phase 3 PAH study to use a primary endpoint focused solely on major morbidity and mortality events. The results demonstrated a 76% reduction in the risk of a composite outcome of all-cause death, lung transplantation, and hospitalization for PAH lasting 24 hours or more, compared to placebo. The FDA has set a target action date of October 25, 2025, under the Prescription Drug User Fee Act.

Merck & Co., Inc. (NYSE:MRK) is a leading healthcare company that operates through two main segments including the Pharmaceutical and Animal Health Segments.

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