WINREVAIR (sotatercept-csrk)
Recently diagnosed pulmonary arterial hypertension · Adults with recently diagnosed pulmonary arterial hypertension receiving background therapy
MRK · Merck
Full timeline
4 milestonesFDA decision expected
FDA assigned a September 21, 2026 PDUFA date to the HYPERION-based WINREVAIR label-update application.
Merck — Fourth-quarter 2025 results and regulatory update↗FDA accepted the sBLA
FDA accepted the supplemental application seeking to update the U.S. label based on the Phase 3 HYPERION trial.
Merck — Fourth-quarter 2025 results and regulatory update↗HYPERION met its primary endpoint
WINREVAIR reduced the risk of clinical-worsening events by 76% versus placebo in adults with recently diagnosed PAH receiving background therapy.
Merck — Positive Phase 3 HYPERION results↗Phase 3 HYPERION study started
The event-driven HYPERION trial began evaluating sotatercept in adults diagnosed with pulmonary arterial hypertension within the prior year.
ClinicalTrials.gov — HYPERION study record (NCT04811092)↗Related News
No related news available.