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HRMY FDA decision: Feb 17, 2026

Updated ·next FDA decision on the calendar
✓ 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%

Questions

Was WAKIX (pitolisant) approved by the FDA?

Yes. The FDA approved the application for WAKIX (pitolisant) on February 17, 2026. The primary source is linked on this page.

Which company is behind WAKIX (pitolisant)?

WAKIX (pitolisant) is a Harmony Biosciences Holdings Inc. (HRMY) program. The FDA decision came on February 17, 2026; the company's own announcement is linked on this page.

How did HRMY stock trade into the FDA decision?

Measured over the 120 trading days before the decision (T-120 to T-1), HRMY moved -3.8%. That is the recorded price path into this specific event -- historical measurement, not a prediction, and not investment advice.