PDUFA for WINREVAIR label update based on Phase 3 HYPERION
The FDA’s decision on Merck &’s WINREVAIR (sotatercept-csrk) for Pulmonary arterial hypertension (recently diagnosed patients; label update) was due on Sep 21, 2026. The outcome isn’t recorded here yet — the linked source has the latest.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Merck & Co., Inc. MRK
- Drug
- WINREVAIR (sotatercept-csrk)
- For
- Pulmonary arterial hypertension (recently diagnosed patients; label update)
- Stage
- sBLA under review
- When
- Sep 21, 2026
- Source note
- FDA accepted a new sBLA in February 2026 to update the WINREVAIR label with Phase 3 HYPERION data (76% reduction in risk of clinical worsening in adults diagnosed within 12 months); PDUFA date September 21, 2026 per Merck's Q4 2025 earnings announcement and Q2 2026 earnings call.
- Checked
- Checked by a person when it was added
- Source: merck.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- MRK headlines on this site
Merck & expects to report results from its Phase 3 study of sacituzumab tirumotecan (MK-2870) for Advanced/recurrent endometrial cancer (TroFuse-005) in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
More details
- Entry
- Sac-TMT TroFuse-005 endometrial cancer detailed Ph3 data presentation · Clinical trial results (readout / topline data)
- Drug
- sacituzumab tirumotecan (MK-2870)
- For
- Advanced/recurrent endometrial cancer (TroFuse-005)
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Merck Aug 4, 2026 Q2 earnings slides list this under milestones 'expected over next six months' (Aug 2026-Jan 2027); no congress named, so H2 2026 is an approximation of that window. Topline (OS and PFS met) was announced in Q2 2026.
- Checked
- Checked by a person when it was added
- Verify it
- Source: merck.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- MRK headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page