Harmony Biosciences Presents New Secondary Outcome Data From Phase 2 Signal Detection Study In Patients With Prader-Willi Syndrome
Portfolio Pulse from Benzinga Newsdesk
Harmony Biosciences (NASDAQ:HRMY) has presented new secondary endpoint data from its Phase 2 study evaluating pitolisant for the treatment of excessive daytime sleepiness in Prader-Willi syndrome. The data showed improvements in behavioral disturbances. The company also announced plans to initiate its Phase 3 registrational TEMPO study in Q4 2023. Pitolisant is marketed as WAKIX® in the U.S. and is FDA approved to treat EDS or cataplexy in adult patients with narcolepsy.

October 05, 2023 | 12:07 pm
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Harmony Biosciences has announced positive secondary endpoint data from its Phase 2 study of pitolisant, which could potentially lead to a new indication for the drug. The company also plans to initiate a Phase 3 study in Q4 2023.
The positive secondary endpoint data from the Phase 2 study of pitolisant indicates potential for a new indication for the drug. This could potentially expand the market for the drug and increase revenues for Harmony Biosciences. The announcement of the Phase 3 study also indicates progress in the drug's development, which could be viewed positively by investors.
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