Applied Therapeutics Receives Complete Response Letter from U.S. FDA Regarding New Drug Application for Govorestat for Classic Galactosemia
Portfolio Pulse from
Applied Therapeutics received a Complete Response Letter from the FDA for its New Drug Application for govorestat, a treatment for Classic Galactosemia. This indicates that the FDA has found issues that need to be addressed before approval.
November 27, 2024 | 9:30 pm
News sentiment analysis
Sort by:
Ascending
NEGATIVE IMPACT
Applied Therapeutics received a Complete Response Letter from the FDA for its NDA for govorestat, indicating issues that need resolution before approval.
The FDA's issuance of a Complete Response Letter suggests that there are significant issues with the NDA for govorestat that need to be addressed. This is typically seen as a setback for the company, potentially delaying the drug's approval and affecting investor sentiment negatively in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100