MRK PDUFA Date: Sacituzumab tirumotecan

Name: Sacituzumab tirumotecan FDA decision
Start: 2027-06-15
End: 2027-06-15

Page updated November 5, 2026·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

FDA decision (PDUFA) target Jun 15, 2027 · Merck & Co., Inc. · Adults with endometrial cancer previously treated with platinum chemotherapy and a PD-1/PD-L1 inhibitor

Source: Merck 8-K 2026-10-29 (EX-99.1, Q3 2026 results). “FDA set Prescription Drug User Fee Act (PDUFA) date of June 15, 2027.”

Key facts

FDA PDUFA target date2027-06-15

Drug / candidateSacituzumab tirumotecan (sac-TMT)

IndicationAdults with endometrial cancer previously treated with platinum chemotherapy and a PD-1/PD-L1 inhibitor

CompanyMerck & Co., Inc.

Market-cap tierLarge

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FAQ

When is the MRK PDUFA date?

The FDA PDUFA target date for MRK (Merck & Co., Inc.) is 2027-06-15 for Sacituzumab tirumotecan (sac-TMT). Dates are company/FDA-sourced and can slip. Verify against primary filings.

What is MRK's drug Sacituzumab tirumotecan?

Sacituzumab tirumotecan (sac-TMT) is Merck & Co., Inc.'s candidate under FDA review for Adults with endometrial cancer previously treated with platinum chemotherapy and a PD-1/PD-L1 inhibitor.