pdufa.bio
CalendarDecisionsReadoutsPatents
Drug IndexStocksScreenerConferencesAdvisory Committees
StudiesRun-up by YearLearnGlossaryMethodologyAPIAccount
Pro
Home › PDUFA Calendar › MRK

MRK PDUFA Date: WINREVAIR (sotatercept-csrk)

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ Approved · the FDA decided this application on September 21, 2026 (FDA record; announced September 22, 2026) on its goal date. Decision page with the source and measured reaction.
FDA decision Approved September 21, 2026 · Merck & Company Inc. · Pulmonary arterial hypertension (PAH, WHO* Group 1)
More Cardiovascular FDA decisions →All September 2026 PDUFA dates →

The story

WINREVAIR (sotatercept-csrk) was approved by the FDA on September 21, 2026 to treat Pulmonary arterial hypertension (PAH, WHO* Group 1).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthIONS-olezarsen . 2026-06-30Same area: Metabolic / Cardio . OlezarsenMLYS . 2026-12-22Same area: Metabolic / Cardio . LorundrostatTLX . 2026-09-11Same month decision . TLX101-Px
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

MRK run-up into the PDUFA (last ~120 days)

$123.93$109.18
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA decisionApproved September 21, 2026
FDA goal date2026-09-21
Drug / candidateWINREVAIR (sotatercept-csrk)
IndicationPulmonary arterial hypertension (PAH, WHO* Group 1)
CompanyMerck & Company Inc.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT04811092

New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs.

See the full 2026 PDUFA calendar →

FAQ

What did the FDA decide on MRK's WINREVAIR (sotatercept-csrk)?
The FDA decided MRK's (Merck & Company Inc.) application for WINREVAIR (sotatercept-csrk) on September 22, 2026: Approved. The FDA goal date for this application was 2026-09-21. Verify against the linked primary source.
What is MRK's drug WINREVAIR (sotatercept-csrk)?
WINREVAIR (sotatercept-csrk) is Merck & Company Inc.'s drug, approved by the FDA on September 21, 2026 for Pulmonary arterial hypertension (PAH, WHO* Group 1).
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · large-cap cohortn=790 · median +0.0% · 50% up
under -30%: 2 of 790 (0%)<-30-30 to -15%: 2 of 790 (0%)-15 to -7%: 6 of 790 (1%)-7 to -3%: 29 of 790 (4%)-3 to +3%: 707 of 790 (89%)±3+3 to +7%: 35 of 790 (4%)+7 to +15%: 5 of 790 (1%)+15 to +30%: 2 of 790 (0%)over +30%: 2 of 790 (0%)>+30
Distribution of next-day % moves after the FDA decision for large-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.