Harmony Biosciences reported a strong second quarter in 2024, with WAKIX net revenue reaching $172.8 million, a 29% increase year-over-year. The company is advancing its pitolisant high-dose development program and expects a PDUFA date in 2028. They are also on track to submit a supplemental new drug application for pitolisant in Idiopathic Hypersomnia in the fourth quarter of 2024 and reiterated their 2024 net product revenue guidance of $700 - $720 million.
WAKIX net revenue was $172.8 million in Q2 2024, a 29% increase year-over-year.
The average number of patients on WAKIX increased by approximately 250 sequentially to approximately 6,550 for the quarter ended June 30, 2024.
Received FDA approval for WAKIX for the treatment of EDS in pediatric patients 6 years and older with narcolepsy on June 21, 2024, and executed commercial launch July 1, 2024.
Harmony is on track to submit supplemental new drug application (sNDA) for pitolisant in IH in the fourth quarter of 2024.
Harmony Biosciences expects full year 2024 net product revenue of $700 million to $720 million.
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