Winrevair shows promise in PAH trial, says Merck

RAHWAY, N.J. - Merck (NYSE:MRK), a prominent player in the pharmaceutical industry with a market capitalization of $225 billion and impressive gross profit margins of 77%, has unveiled results from the Phase 3 ZENITH trial of WINREVAIR™ (sotatercept-csrk), demonstrating a significant reduction in the risk of major morbidity and mortality events in adults with pulmonary arterial hypertension (PAH), WHO functional class III or IV. The findings, presented today at the American College of Cardiology’s Annual Scientific Session (ACC.25) and published in the New England Journal of Medicine, indicate a 76% risk reduction compared to placebo.

The trial included 172 patients on maximum tolerated background PAH therapy, with a median follow-up of 10.6 months. WINREVAIR showed a reduction in the composite endpoint of all-cause death, lung transplantation, and PAH worsening-related hospitalization by 76% (HR=0.24 [95% CI, 0.13-0.43]; p

The ZENITH study was stopped early due to overwhelming efficacy, and patients were offered WINREVAIR in the SOTERIA open-label extension study. The safety profile of WINREVAIR in this trial was consistent with previous studies, with no treatment discontinuations due to adverse events.

Secondary endpoints showed numerical improvements but were not formally tested due to a prespecified hierarchical testing strategy. The key secondary endpoint of overall survival did not reach the heightened threshold required for statistical significance at the interim analysis.

WINREVAIR is approved in over 40 countries based on the STELLAR trial results and is currently under review by regulatory authorities worldwide. The Phase 3 HYPERION study evaluating WINREVAIR in newly diagnosed patients with PAH is also stopping early for final analysis based on the positive interim analysis from the ZENITH trial.

The ZENITH trial’s results contribute to the growing body of evidence supporting WINREVAIR’s potential to change PAH treatment practices. These developments are based on a press release statement from Merck. According to InvestingPro analysis, Merck maintains strong financial health with a "GREAT" overall score, and currently appears undervalued based on comprehensive Fair Value analysis. With 55 consecutive years of dividend payments and annual revenues exceeding $64 billion, the company demonstrates robust financial stability to support its innovative drug development programs. For deeper insights into Merck’s financial health and growth potential, investors can access the detailed Pro Research Report, available exclusively on InvestingPro.

In other recent news, Merck & Co. has reported significant developments across various fronts. The company has presented promising Phase 3 trial results for a new subcutaneous formulation of pembrolizumab, aimed at treating metastatic non-small cell lung cancer, which could potentially reduce treatment time for patients and healthcare professionals. Applications for this formulation are under review by the U.S. FDA and the European Medicines Agency. Additionally, Merck has received approval from the European Commission for its Capvaxive pneumococcal vaccine for adults, expanding its availability across the EU and other regions. This approval follows the vaccine’s previous authorization in the U.S., Canada, and Australia.

Moreover, Merck has entered into a new licensing agreement with Jiangsu Hengrui Pharmaceuticals, granting it exclusive rights to develop and commercialize HRS-5346, an oral small molecule Lp(a) inhibitor. This agreement is seen as a strategic move to enhance Merck’s cardio-metabolic pipeline. Citi has maintained a Buy rating for Merck, with a $115 price target, expressing optimism about the potential market for treatments targeting elevated Lp(a). Meanwhile, several unnamed pharmaceutical companies have been accelerating shipments of medicines to the U.S. in response to potential tariff threats, utilizing major transport services like UPS and DHL to avoid disruptions.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.