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.
FDA record of the action: the FDA approved on February 13, 2026, per NDA 211150 SUPPL-6 (FDA letter). The sponsor announced it on February 17, 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.
Questions
Was WAKIX (pitolisant) approved by the FDA?
Yes. The FDA approved the application for WAKIX (pitolisant) on February 13, 2026, per the FDA's own record. The company announced it 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 13, 2026; the FDA's own record of the decision 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.
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