Harmony Biosciences announced that the FDA has granted Orphan Drug designation to pitolisant for the treatment of Prader-Willi syndrome, or PWS. Approximately 15,000 – 20,000 people in the U.S. are living with PWS, the majority experiencing behavioral symptoms and more than half with excessive daytime sleepiness. In the upcoming Phase 3 registrational TEMPO study, Harmony will assess the safety and efficacy of pitolisant in treating EDS and behavioral disturbances in PWS, anticipated to begin in Q1.
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Read More on HRMY:
- Harmony Biosciences price target raised to $42 from $33 at Mizuho
- Harmony Biosciences’ treatment of PWS receives FDA orphan designation
- Harmony Biosciences sees FY24 net product revenue $700M-$720M
- Harmony Biosciences sees Q4, FY23 net product revenue growth of over 30%
- Harmony Biosciences downgraded to Underperform from Neutral at BofA