Harmony Biosciences Provides Update on the Status of the Supplemental New Drug Application for Pitolisant in Idiopathic Hypersomnia
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Harmony Biosciences received a Refusal to File letter from the FDA for its supplemental new drug application for pitolisant, intended to treat excessive daytime sleepiness in idiopathic hypersomnia. Despite this setback, the company's 2025 net revenue guidance remains unchanged.
February 19, 2025 | 1:30 pm
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NEGATIVE IMPACT
Harmony Biosciences received a Refusal to File letter from the FDA for pitolisant, impacting its short-term prospects. However, the company's long-term revenue guidance remains unchanged.
The FDA's Refusal to File letter is a regulatory setback for Harmony Biosciences, likely causing short-term negative sentiment and potential stock price decline. However, the unchanged revenue guidance suggests confidence in long-term prospects, mitigating some negative impact.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100