# WINREVAIR (sotatercept-csrk) PDUFA Event: Recently diagnosed pulmonary arterial hypertension

Canonical URL: https://biopharmsignal.com/pdufa-calendar/MRK/winrevair-recently-diagnosed-pah-hyperion

Ticker: MRK

Company: Merck

Event date: 2026-09-21

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: sBLA

FDA decision expected. FDA assigned a September 21, 2026 PDUFA date to the HYPERION-based WINREVAIR label-update application.

## Event Timeline

### September 21, 2026 — FDA 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](https://www.merck.com/news/merck-highlights-progress-advancing-broad-diverse-pipeline/)

### February 2026 — 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](https://www.merck.com/news/merck-highlights-progress-advancing-broad-diverse-pipeline/)

### September 30, 2025 — 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](https://www.merck.com/news/winrevair-sotatercept-csrk-reduced-the-risk-of-clinical-worsening-events-by-76-compared-to-placebo-in-patients-recently-diagnosed-with-pah-on-background-therapy-in-phase-3-hyperion-trial/)

### March 18, 2022 — 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)](https://clinicaltrials.gov/study/NCT04811092)

## Related Pages

- MRK PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/MRK.md

- MRK company profile: https://biopharmsignal.com/company/MRK.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md