Peptide News Digest

#Zenith-Trial

2 stories

Regulatory · View digest

Merck Winrevair (Sotatercept-csrk) Pulmonary Arterial Hypertension Label Expansion PDUFA Target Date September 21, 2026

Merck (NYSE: MRK) awaits its September 21, 2026 PDUFA target action date for a further label expansion of Winrevair (sotatercept-csrk, an activin signaling inhibitor administered as subcutaneous injection every three weeks) in pulmonary arterial hypertension (PAH). Winrevair was originally FDA-approved March 26, 2024 for adults with PAH (WHO Group 1) to increase exercise capacity, improve WHO functional class, and reduce risk of clinical worsening events, based on the Phase 3 STELLAR trial. The pending label expansion is expected to cover an earlier line of therapy and/or a broader patient population based on the ZENITH and HYPERION Phase 3 trials that reported earlier in 2026 (ZENITH: PAH high-risk patients on maximal background therapy; HYPERION: newly diagnosed PAH). The Winrevair franchise reached $260 million in Q2 2026 revenue and is on track to reach $1 billion annual run rate before end of 2026. Sotatercept-csrk is a fusion protein of activin receptor type IIA and the Fc portion of human immunoglobulin.

Clinical Trials · View digest

Alnylam Vutrisiran HELIOS-B ESC 2026 Prespecified Subgroup Analyses Show Consistent Benefit With or Without Background Tafamidis; French Real-World Amylo'ExTTRa Study

Alnylam Pharmaceuticals (NASDAQ: ALNY) presented Saturday August 29 and Sunday August 30, 2026 late-breaking prespecified subgroup analyses from the Phase 3 HELIOS-B trial of vutrisiran (AMVUTTRA, an RNAi therapeutic targeting transthyretin for transthyretin amyloidosis with cardiomyopathy, ATTR-CM) at ESC Congress 2026 Munich. Vutrisiran demonstrated consistent clinical benefit across all-cause mortality and recurrent cardiovascular events in patients with or without background tafamidis (the transthyretin tetramer stabilizer marketed as Vyndaqel/Vyndamax by Pfizer). The HELIOS-B trial had documented 28.2% reduction in all-cause mortality and 32.8% reduction in cardiovascular events with vutrisiran plus stabilizer. Additional analyses examined healthy aging, functional capacity, safety, and outcomes by sex. Alnylam also presented Amylo'ExTTRa, a large real-world analysis from the French National Health Data System characterizing the multisystem burden of ATTR-CM beyond cardiac manifestations. Vutrisiran anchors Alnylam's ATTR franchise alongside inclisiran (Leqvio, licensed to Novartis for hypercholesterolemia) and zilebesiran (Phase 3 ZENITH trial in hypertension).