pdufa.bio
HomeDecisionsREGN 2026-04-23

REGN FDA decision: Apr 23, 2026

Updated ·next FDA decision on the calendar
✓ APPROVED

Regeneron Pharmaceuticals Inc.: Otarmeni (lunsotogene parvec-cwha) · Sensorineural hearing loss.

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

PDUFA 4/23/26$812.27$62811/6/25
Daily close, T-120 (11/6/25) through T+5. Run-up high $812.27 on 1/12/26, low $628 on 11/12/25 (T-120 to T-1). FDA decision 4/23/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-04-23
OutcomeApproved
Drug / candidateOtarmeni (lunsotogene parvec-cwha)
CompanyRegeneron Pharmaceuticals Inc.
120-day run-up (T-120→T-1)+14.3%

Question

Was Otarmeni (lunsotogene parvec-cwha) approved by the FDA?

Yes. The FDA approved the application for Otarmeni (lunsotogene parvec-cwha) on April 23, 2026. The primary source is linked on this page.