Harmony Biosciences' Wakix fails PhIII hypersomnia study; Florida gene therapy startup downsizes

13 Oct 2023

Phase 3Gene TherapyDrug ApprovalPhase 2

Plus Phase II data on ABION’s MET tyrosine kinase inhibitor, and 60 Degrees Pharmaceuticals giving up on repurposing its antimalarial drug for Covid-19. Harmony Biosciences’ drug failed the primary goal in a Phase III study and investors reacted by shedding the biotech’s share price $HRMY by about 30% Friday morning. The Pennsylvania drugmaker said its treatment candidate pitolisant did not achieve statistical significance on excessive daytime sleepiness in the randomized withdrawal phase of the INTUNE study, which includes patients with the rare and chronic disease idiopathic hypersomnia. The FDA approved the tablets, sold as Wakix, in 2019 to treat excessive daytime sleepiness in adults with narcolepsy. — Kyle LaHucik

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Organizations

Harmony Biosciences LLC

ABION, Inc.60 Degrees Pharmaceuticals, Inc.

Indications

COVID-19Excessive Daytime SleepinessIdiopathic Hypersomnia

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Targets

Drugs

Pitolisant Hydrochloride

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