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

Author: Benzinga Newsdesk | March 28, 2024 04:32pm

The FDA notified Applied Therapeutics that it required additional time to review supplemental analyses of previously submitted data that had been provided by Applied in response to the FDA's routine information requests and determined that the additional information constitutes a Major Amendment to the NDA. "While the PDUFA action date extension represents a delay, we remain confident in the potential for govorestat approval for Galactosemia and we will continue to work closely with the FDA throughout the review process," said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics.

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