HRMY FDA decision dates

Page updated November 4, 2026·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

HRMY has 1 upcoming FDA decision date; the nearest is Apr 1, 2027 for Pitolisant GR (gastro-resistant formulation) - NDA. 2 past decisions are on record below, each on its own page. One event, one page: past decisions never share a URL with a live catalyst.

HRMY catalyst hub · full calendar

Upcoming

Apr 1, 2027 in 147 daysPitolisant GR (gastro-resistant formulation) - NDA

Decided

Feb 17, 2026 ✓ ApprovedWAKIX (pitolisant)Feb 19, 2025 CRLprice-only

Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.

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