Harmony Biosciences Receives FDA Orphan Drug Designation For Pitolisant
Portfolio Pulse from Benzinga Newsdesk
Harmony Biosciences has been granted FDA Orphan Drug Designation for Pitolisant, a significant milestone that could enhance the company's market position and potentially lead to expedited development and approval processes for this drug.

February 20, 2024 | 1:07 pm
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Harmony Biosciences receiving FDA Orphan Drug Designation for Pitolisant is a positive development, likely to boost investor confidence and potentially accelerate the drug's market entry.
FDA Orphan Drug Designation is a critical regulatory milestone that can significantly impact a biotech company's valuation and market position. For Harmony Biosciences, this designation for Pitolisant not only validates the drug's potential but also offers various benefits including tax credits, eligibility for grant funding, and potentially seven years of market exclusivity upon approval. These factors are likely to positively influence HRMY's stock price in the short term as they reduce development risk and potentially accelerate the timeline to commercialization.
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