WINREVAIR (sotatercept-csrk) was approved by the FDA on September 21, 2026 for recently diagnosed pulmonary arterial hypertension (label update).
Verified against: FDA action day September 21, 2026 (BLA 761363 S-017) · Announcement September 22, 2026 (Merck news release) · Goal date September 21, 2026 (Merck 10-Q and 8-K).
WINREVAIR (sotatercept-csrk) label update approved September 21, 2026, its PDUFA goal date (FDA letter); Merck announced it on September 22: HYPERION trial data in adults newly diagnosed with PAH added to the U.S. label.
The PDUFA goal date was September 21, 2026, sourced to Merck's Q2 2026 10-Q and its 8-K of February 3, 2026. The FDA's approval letter for BLA 761363 supplements 012, 016 and 017 is signed September 21, 2026 (Drugs@FDA), so the FDA acted on the goal date; Merck's release, which calls it "today's approval", went out at 6:45 am ET on September 22. This page first recorded the decision as one day late from that release and was corrected when the letter posted. This is a supplemental application: the approved indication is unchanged; the label gains HYPERION efficacy and safety data, and supplement 017 adds a contraindication for serious hypersensitivity.
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.
Primary source: FDA approval letter, BLA 761363 S-012/S-016/S-017, September 21, 2026
FDA record of the action: the FDA approved on September 21, 2026, per BLA 761363 S-017 (FDA letter). The sponsor announced it on September 22, 2026. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| OrbiMed Advisors | 663,400 | $85.2 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Yes. The FDA approved the application for WINREVAIR (sotatercept-csrk) - HYPERION label update on September 21, 2026, per the FDA's own record. The company announced it on September 22, 2026. The primary source is linked on this page.
WINREVAIR (sotatercept-csrk) - HYPERION label update is a Merck & Co., Inc. (MRK) program. The FDA decision came on September 21, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), MRK moved +24.3%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.