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HRMY FDA decision — Feb 17, 2026

✓ APPROVED

Harmony Biosciences Holdings Inc. — WAKIX (pitolisant) · cataplexy, pediatric patients 6 years of age and o.

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

PDUFA 2/17/26$40.51$25.99/2/25
Daily close, T-120 (9/2/25) through T+5. Run-up high $40.51 on 12/18/25, low $25.9 on 10/24/25 (T-120 to T-1). FDA decision 2/17/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-02-17
OutcomeApproved
Drug / candidateWAKIX (pitolisant)
CompanyHarmony Biosciences Holdings Inc.
120-day run-up (T-120→T-1)-3.8%