pdufa.bio
HomeDecisionsMRK 2026-04-21

MRK FDA decision: Apr 21, 2026

Updated ·next FDA decision on the calendar
✓ APPROVED

Merck & Company Inc.: IDVYNSO (doravirine/islatravir) · HIV-1 Infection.

Run-up into the decision (T-120 → T+5)

PDUFA 4/21/26$123.93$82.4911/4/25
Daily close, T-120 (11/4/25) through T+5. Run-up high $123.93 on 2/25/26, low $82.49 on 11/11/25 (T-120 to T-1). FDA decision 4/21/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-04-21
OutcomeApproved
Drug / candidateIDVYNSO (doravirine/islatravir)
CompanyMerck & Company Inc.
120-day run-up (T-120→T-1)+33.1%

Questions

Was IDVYNSO (doravirine/islatravir) approved by the FDA?

Yes. The FDA approved the application for IDVYNSO (doravirine/islatravir) on April 21, 2026. The primary source is linked on this page.

Which company is behind IDVYNSO (doravirine/islatravir)?

IDVYNSO (doravirine/islatravir) is a Merck & Company Inc. (MRK) program. The FDA decision came on April 21, 2026; the company's own announcement is linked on this page.

How did MRK stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), MRK moved +33.1%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.