On Monday, Merck & Co Inc (NYSE:MRK) revealed topline results from the Phase 3 ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH, WHO Group 1) functional class (FC) III or IV at high risk of mortality.

PAH is high blood pressure in pulmonary arteries, which carry oxygen-poor blood from the heart to the lungs.

ZENITH met its primary endpoint of time to first morbidity or mortality event (all-cause death, lung transplantation, or PAH worsening-related hospitalization of ≥ 24 hours).

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In the study, Winrevair demonstrated a statistically significant and clinically meaningful reduction in the risk of morbidity or mortality events compared to placebo, on top of background PAH therapy.

An independent data monitoring committee has recommended that ZENITH be stopped early and that all participants be offered the opportunity to receive Winrevair through the SOTERIA open-label extension study.

In the preliminary assessment, adverse events and serious adverse events were balanced between the treatment groups.

Winrevair is currently approved in the U.S. and 36 countries based on the Phase 3 STELLAR trial results.

In March, the FDA approved Winrevair for injection for adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve WHO functional class (FC), and reduce the risk of clinical worsening events.

Most recently, in November of this year, WINREVAIR was submitted for approval in Japan based on the STELLAR trial and results from an open-label Phase 3 study in Japanese patients.

Price Action: MRK stock is up 1.93% at $101.09 at last check Monday.

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