WINREVAIR (sotatercept-csrk) label update approved: HYPERION trial data in adults newly diagnosed with PAH added to the U.S. label (announced Sep 22 2026).
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (3/31/26) through T+0. Run-up high $156.45 on 8/25/26, low $109.18 on 4/30/26 (T-120 to T-1). FDA decision 9/22/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-09-22
OutcomeApproved
Drug / candidateWINREVAIR (sotatercept-csrk) - HYPERION label update
IndicationPulmonary arterial hypertension (WHO Group 1): label updated with HYPERION data in adults newly diagnosed within 12 months
CompanyMerck & Co., Inc.
Market-cap tierLarge
120-day run-up (T-120→T-1)+24.3%
Cohort decision-day move (history)1.0% median (n=835)
The PDUFA goal date was September 21, 2026, sourced to Merck's Q2 2026 10-Q and its 8-K of February 3, 2026. Merck's release of September 22 calls it "today's approval", so the decision is recorded one day after the goal date; the FDA's supplement action letter is not yet in Drugs@FDA and the margin will be corrected if the letter is dated earlier. This is a supplemental application: the approved indication is unchanged and the label gains HYPERION efficacy and safety data plus additional hypersensitivity language.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.
Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.