Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 5:03 AM ET
Pitolisant GR (gastro-resistant formulation) is a Harmony Biosciences Holdings, Inc. program in pitolisant gastro-resistant formulation (NDA accepted July 2026). Its PDUFA date is Apr 1, 2027, the FDA's goal date to complete review of the application. Every date links its source.
Indication under review: Pitolisant gastro-resistant formulation (NDA accepted July 2026). Sponsor: Harmony Biosciences Holdings, Inc. (HRMY). Market-cap tier at the time we tracked it: Mid. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is Pitolisant GR (gastro-resistant formulation)'s next FDA decision or readout?
Pitolisant GR (gastro-resistant formulation)'s PDUFA date is Apr 1, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at Pitolisant GR (gastro-resistant formulation)'s most recent FDA decision?
No FDA decision for Pitolisant GR (gastro-resistant formulation) is in our archive yet.
What is Pitolisant GR (gastro-resistant formulation) used for?
In our records Pitolisant GR (gastro-resistant formulation) is under review or in development for Pitolisant gastro-resistant formulation (NDA accepted July 2026).
Who makes Pitolisant GR (gastro-resistant formulation)?
Harmony Biosciences Holdings, Inc. (HRMY).
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
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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