Applied Therapeutics Says FDA Has Extended Review Period For NDA For Govorestat (AT-007) For Treatment Of Classic Galactosemia By Three Months; PDUFA Target Action Date November 28, 2024
Portfolio Pulse from Benzinga Newsdesk
The FDA has extended the review period for Applied Therapeutics' NDA for Govorestat (AT-007), aimed at treating Classic Galactosemia, by three months, setting a new PDUFA target action date to November 28, 2024. This extension is due to the FDA requiring more time to review supplemental analyses of previously submitted data by Applied Therapeutics, which is considered a Major Amendment to the NDA. Despite the delay, Applied Therapeutics remains confident in Govorestat's approval prospects.
March 28, 2024 | 8:32 pm
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Applied Therapeutics faces a three-month delay in the FDA review process for its NDA for Govorestat (AT-007), with a new PDUFA target action date set for November 28, 2024. Despite this, the company remains optimistic about the drug's approval.
The extension of the FDA review period for Applied Therapeutics' NDA for Govorestat (AT-007) is a mixed signal. On one hand, the delay could be seen negatively by investors as it pushes back potential approval and commercialization. On the other hand, the company's confidence in the eventual approval of the drug for treating Classic Galactosemia could maintain investor optimism. The net impact on the stock price in the short term is likely neutral, as the market digests the delay alongside the company's positive outlook.
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IMPORTANCE 90
RELEVANCE 100