sotatercept

Also known as WINREVAIR.

Latest news on sotatercept

22 September 2026
Merck updates WINREVAIR label with Phase 3 HYPERION data for newly diagnosed PAH

FDA updates PAH therapy label to include HYPERION data showing a 76% reduction in clinical worsening when added to background therapy for patients diagnosed within 12 months.

30 April 2026
Merck & Co Q1 2026 Results — Sales Growth, Regulatory Approvals and Clinical Milestones

Q1 revenue $16.3B; KEYTRUDA $8.0B. GAAP loss $1.72/sh, non-GAAP loss $1.28/sh after $9.0B Cidara charge. Announced Terns acquisition; raised 2026 sales to $65.8-67.0B and non-GAAP EPS $5.04-5.16

29 March 2026
Merck: WINREVAIR Phase 2 CADENCE shows proof‑of‑concept in CpcPH‑HFpEF

Met primary endpoint with significant PVR reduction at 24 weeks vs placebo. Also favorable mPAP/PAWP, NT‑proBNP and 6MWD trends, delayed clinical worsening; safety consistent with known profile.

16 March 2026
Merck Presents New Cardio-Pulmonary Data at ACC.26

Merck shares positive Phase 3 and Phase 2 trial results for enlicitide and WINREVAIR™ at ACC.26, highlighting advancements in hypercholesterolemia and CpcPH-HFpEF research.

3 February 2026
Merck Announces Q4 and Full-Year 2025 Financial Results, Highlights Pipeline Progress

Strong oncology and animal health sales, positive trial results, and strategic acquisitions drive growth. 2026 outlook projects sales up to $67B, with EPS impacted by acquisition charges.

12 December 2025
Merck's WINREVAIR™ Gains EU CHMP Support for Broader PAH Use

EU CHMP backs expanded WINREVAIR™ use for PAH, covering WHO FC II-IV. Decision by European Commission expected Q1 2026.

18 November 2025
Merck's WINREVAIR Achieves Primary Endpoint in Phase 2 Study for Pulmonary Hypertension

WINREVAIR reduced pulmonary vascular resistance in Phase 2 CADENCE study, supporting Phase 3 development for treating pulmonary hypertension due to heart failure with preserved ejection fraction.

30 October 2025
Merck Announces Q3 2025 Financial Results

Sales rose 4% to $17.3B. KEYTRUDA up 10%, GARDASIL down 24%. GAAP EPS $2.32, Non-GAAP $2.58. FDA approved KEYTRUDA QLEX. Acquired Verona Pharma. Full-year sales outlook: $64.5B-$65B.

27 October 2025
Merck's WINREVAIR Approved by FDA for Expanded PAH Treatment

WINREVAIR, now approved for PAH, improves exercise capacity, reduces clinical worsening risks, and shows significant efficacy in the ZENITH trial. Monitor hemoglobin and platelets during treatment.

30 September 2025
Merck's WINREVAIR Reduces PAH Clinical Worsening Risk by 76% in Phase 3 Trial

WINREVAIR, when started within a year of PAH diagnosis, significantly lowers clinical worsening risk. Safety profile aligns with previous trials. Results shared at ERS 2025 and published in NEJM.