Aminohippuric acid

MSD's Phase III ZENITH trial of WINREVAIR (sotatercept-csrk) for pulmonary arterial hypertension (PAH) met its primary endpoint. The double-blind, placebo-controlled trial involved 172 PAH patients with high mortality risk. WINREVAIR, alongside standard PAH therapy, achieved the primary outcome of time to first morbidity or mortality event at interim analysis. Adverse events were similar across treatment and placebo groups. An independent data monitoring committee recommended early termination of the ZENITH study.

Merck announced positive Phase 3 ZENITH study results for WINREVAIR in PAH patients, demonstrating significant reduction in morbidity/mortality risk. The study met its primary endpoint, leading to early termination and offering WINREVAIR to participants. WINREVAIR is currently approved in the U.S. and 36 countries, with a submission for Japanese approval in November.

Merck announced significant progress in its Phase 3 ZENITH study for WINREVAIR, showing a statistically significant reduction in the risk of morbidity or mortality events in pulmonary arterial hypertension (PAH) patients. The study's positive results led to an early stop, allowing all participants to receive WINREVAIR. The treatment, already approved in the U.S. and 36 other countries, was recently submitted for approval in Japan. Merck's financial health and market position are strong, with a market capitalization of $250.89 billion and a robust gross profit margin of 76.59%.

ZENITH study demonstrates overwhelming efficacy of WINREVAIR, an activin signaling inhibitor, in reducing risk of death, lung transplantation, or PAH hospitalizations in advanced PAH patients, prompting early conclusion and offering all participants WINREVAIR.

Cereno Scientific secures SEK 250 million in debt financing, including SEK 175 million in cash loans and SEK 75 million in convertible loans from Fenja Capital II and Arena Investors. The funds will support milestones through 2026, such as FDA approval for CS1 in PAH and Phase II study for CS014 in IPF.

PTC Therapeutics announced the FDA's target action date of July 29, 2025, for the review of sepiapterin's NDA for treating PKU in pediatric and adult patients. The Phase 3 APHENITY trial results were published in The Lancet, highlighting sepiapterin's potential to address PKU's unmet medical needs.

Europe approves sotatercept (Winrevair; Merck) as a combination treatment for pulmonary arterial hypertension (PAH) in World Health Organization Functional Class II to III patients, following FDA approval. Based on the Phase 3 STELLAR trial, sotatercept improved exercise capacity, reduced risk of death or clinical worsening, and improved functional class. The drug, a first activin signaling inhibitor, is administered subcutaneously every 3 weeks.

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