Harmony Biosciences Holdings, Inc.
Pitolisant HD
narcolepsy and IH
Countdown
543days
FDA decision · ~ Jan 1, 2028 estimated
What's at stake
The FDA's approval decision on Pitolisant HD for narcolepsy and IH is due ~ Jan 1, 2028. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 8-K
verified 14h ago
“Pitolisant HD (high dose): Opportunity to expand pitolisant franchise with differentiated indications o Phase 3 registrational clinical trials ongoing in narcolepsy (ONSTRIDE 1) and idiopathic hypersomnia (ONSTRIDE 2) § Topline data in 2027”