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REGN FDA decision — Apr 23, 2026

✓ 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%
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