WINREVAIR (sotatercept-csrk) is a Merck & Co., Inc. program in recently diagnosed pulmonary arterial hypertension (label update). The FDA approved it on Sep 21, 2026. 2 FDA decisions on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: recently diagnosed pulmonary arterial hypertension (label update) (approved Sep 21, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Merck & Co., Inc. (MRK). Approval record: Label update (supplemental application) approved September 22, 2026, one day after the September 21 PDUFA goal date, adding HYPERION efficacy and safety data in adults newly diagnosed with PAH (WHO Group 1) at intermediate to high risk. Not a new indication: the approved indication is unchanged; the label gains HYPERION data and additional hypersensitivity safety language. Market-cap tier at the time we tracked it: Large. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
| 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.
No upcoming catalyst is on our calendar for WINREVAIR (sotatercept-csrk); 2 FDA decisions are on record below.
On Sep 22, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records WINREVAIR (sotatercept-csrk) is FDA-approved for recently diagnosed pulmonary arterial hypertension (label update) (approved Sep 21, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Merck & Co., Inc. (MRK).
Yes. The FDA approved an application for WINREVAIR (sotatercept-csrk) on Sep 22, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.