Harmony Biosciences Holdings, Inc.
Pitolisant GR
narcolepsy
Countdown
263days
FDA decision · Mar 27, 2027
What's at stake
The FDA's approval decision on Pitolisant GR for narcolepsy is due Mar 27, 2027. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 8-K
verified 15h ago
“NDA submission in Q2 2026; anticipated PDUFA date in Q1 2027”