MRK PDUFA Date: IDVYNSO

Name: IDVYNSO FDA decision
Start: 2027-04-22
End: 2027-04-22

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 Apr 22, 2027 · Merck & Co., Inc. · Adults with HIV-1 infection (treatment-naive; 96-week data in virologically suppressed adults)

Source: Merck 8-K 2026-10-29 (EX-99.1, Q3 2026 results). “FDA set a PDUFA date for both sNDAs of April 22, 2027.”

Key facts

FDA PDUFA target date2027-04-22

Drug / candidateIDVYNSO

IndicationAdults with HIV-1 infection (treatment-naive; 96-week data in virologically suppressed adults)

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 2027-04-22 for IDVYNSO. Dates are company/FDA-sourced and can slip. Verify against primary filings.

What is MRK's drug IDVYNSO?

IDVYNSO is Merck & Co., Inc.'s candidate under FDA review for Adults with HIV-1 infection (treatment-naive; 96-week data in virologically suppressed adults).