FDA Presses Delay Button For Applied Therapeutics' First Potential Marketed Drug For Rare Disease
Portfolio Pulse from Vandana Singh
The FDA has extended the review period for Applied Therapeutics Inc's New Drug Application for govorestat, a treatment for Classic Galactosemia, by three months, setting a new PDUFA target action date of November 28, 2024. This extension is due to the FDA requiring additional time to review supplemental analyses provided by Applied Therapeutics. The company announced in February 2024 that the FDA granted Priority Review to the NDA, and if approved, govorestat would be Applied Therapeutics' first commercial product. Additionally, the company has submitted a Marketing Authorization Application for govorestat to the EMA, expecting a decision in Q4 2024. Applied Therapeutics reported having $153.5 million in cash as of March 1, 2024, with a cash runway into the first half of 2026. The company's shares are down 6.99% at $6.325.
April 01, 2024 | 4:30 pm
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NEGATIVE IMPACT
The FDA's extension of the review period for Applied Therapeutics' govorestat may impact investor sentiment and the company's stock price in the short term, as reflected by a 6.99% decrease in share price.
The FDA's decision to extend the review period for Applied Therapeutics' key drug candidate, govorestat, directly impacts the company's short-term prospects and investor sentiment. This regulatory delay is likely contributing to the negative price action observed, as investors may adjust their expectations for the drug's market entry timeline and the company's near-term revenue potential. The 6.99% decrease in share price on the announcement day indicates a direct negative impact on investor confidence and stock performance.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100