Applied Therapeutics Announces FDA Acceptance And Priority Review Of New Drug Application For Govorestat For Treatment Of Classic Galactosemia
Portfolio Pulse from Benzinga Newsdesk
Applied Therapeutics announced that the FDA has accepted and granted priority review to its New Drug Application for Govorestat, aimed at treating Classic Galactosemia. This marks a significant milestone for the company as it moves closer to potentially bringing a new treatment option to patients with this rare metabolic disorder.
February 28, 2024 | 1:06 pm
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Applied Therapeutics' New Drug Application for Govorestat has been accepted for priority review by the FDA, signaling a potential breakthrough in the treatment of Classic Galactosemia.
The FDA's acceptance and priority review of Govorestat is a critical regulatory milestone for Applied Therapeutics, indicating a positive outlook on the drug's review process. This development is likely to be viewed favorably by investors, as it not only validates the company's research and development efforts but also brings it a step closer to potentially securing approval for Govorestat. Given the rarity of Classic Galactosemia and the lack of treatment options, this news could significantly impact the company's stock price in the short term, as it enhances the company's prospects and potential market share in the rare disease treatment space.
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