HRMY PDUFA Date: Pitolisant GR Page updated November 5, 2026 · next FDA decision on the calendar · Data as of Nov 5, 2026 5:03 AM ET FDA decision (PDUFA) target Apr 1, 2027 · Harmony Biosciences Holdings, Inc. · Pitolisant gastro-resistant formulation (NDA accepted July 2026)
Key facts FDA PDUFA target date 2027-04-01
Drug / candidate Pitolisant GR (gastro-resistant formulation)
Indication Pitolisant gastro-resistant formulation (NDA accepted July 2026)
Company Harmony Biosciences Holdings, Inc.
Market-cap tier Mid
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See every 2027 PDUFA date → All April 2027 PDUFA dates → FAQ When is the HRMY PDUFA date? The FDA PDUFA target date for HRMY (Harmony Biosciences Holdings, Inc.) is 2027-04-01 for Pitolisant GR (gastro-resistant formulation). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is HRMY's drug Pitolisant GR? Pitolisant GR (gastro-resistant formulation) is Harmony Biosciences Holdings, Inc.'s candidate under FDA review for Pitolisant gastro-resistant formulation (NDA accepted July 2026).
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