Harmony Biosciences Holdings, Inc.
Pitolisant
pediatric cataplexy
Resolved
144days ago
Approval decision · Feb 13, 2026
What's at stake
A final FDA approval decision on Pitolisant for pediatric cataplexy is expected Feb 13, 2026.
Primary source
· SEC 8-K
verified 15h ago
“Received FDA approval of pediatric cataplexy indication on February 13th”