Rare genetic disease, Genetic disorder, Prader-Willi syndrome, Excessive daytime sleepiness
HRMYHarmony Biosciences Holdings IncCatalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for WAKIX® (pitolisant) in Rare genetic disease, Genetic disorder, Prader-Willi syndrome, Excessive daytime sleepiness. The expected timing is based on the latest available company guidance and may change.
TEMPO study. 11/1/22- Initial Ph2 top-line results. 7/20/23- End-of-Ph2 meeting w/ FDA. Presentation at SLEEP & FPWR '23. 2/20/24- Granted Orphan Drug designation. 4/3/24- Ph3 initiated. 11/04/25:- PR No update. 01/12/26:- TEMPO Ph3 topline data in H2 2026, supporting pediatric exclusivity and additional WAKIX regulatory exclusivity. 02/24/26:- TEMPO Ph3 PWS topline data expected H2 2026, supporting WAKIX pediatric and regulatory exclusivity extension. 05/07/26:- TEMPO PWS Ph3 topline remains expected 2H 2026, supporting WAKIX pediatric exclusivity extension to March 2030. 08/04/26:- TEMPO Ph3 PWS topline expected Mid-2027; PDUFA anticipated 2028.
Verification
Confirm timing and program details against the company announcement or filing.