Upcoming FDA decision · April 1, 2027
Pitolisant GR PDUFA date: FDA decision expected April 1, 2027
167 days to goHarmony Biosciences Holdings, Inc. (HRMY) →
The FDA is expected to decide on Pitolisant GR from Harmony Biosciences Holdings, Inc. in Narcolepsy (gastro-resistant formulation) by the PDUFA target action date of April 1, 2027. For Narcolepsy (gastro-resistant formulation). NDA accepted in July 2026. Verified against the company SEC filing on 2026-10-16.
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
April 1
Target action date
NDA
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Verified
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for Pitolisant GR?
- The FDA's PDUFA target action date for Pitolisant GR is April 1, 2027. The FDA can act before that date, and the review can be extended.
- What is Pitolisant GR being reviewed for?
- The application under FDA review covers Narcolepsy (gastro-resistant formulation).
- Which company is developing Pitolisant GR?
- Harmony Biosciences Holdings, Inc. (HRMY).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).