Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
IDVYNSO (doravirine/islatravir) was approved by the FDA on April 20, 2026 to treat HIV-1 infection (as a complete regimen) in adults to replace the current antiretroviral regimen in those who are virologically-suppressed on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine, the 12th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
Merck & Company Inc., IDVYNSO (doravirine/islatravir) · HIV-1 Infection.
Run-up into the decision (T-120 → T+5)
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.
FDA record of the action: the FDA approved on April 20, 2026, per NDA 216964 ORIG-1 (FDA letter). The sponsor announced it on April 21, 2026. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Specialist biotech funds holding MRK, 13F for the quarter ended June 30, 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.
Questions
Was IDVYNSO (doravirine/islatravir) approved by the FDA?
Yes. The FDA approved the application for IDVYNSO (doravirine/islatravir) on April 20, 2026, per the FDA's own record. The company announced it 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 20, 2026; the FDA's own record of the decision 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.
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