Applied Therapeutics Stock Soars As FDA Scraps Panel Meeting For Its Inherited Metabolic Disorder Drug
Portfolio Pulse from Vandana Singh
Applied Therapeutics, Inc. (NASDAQ:APLT) saw its stock soar after the FDA decided not to hold an Advisory Committee meeting for its drug govorestat, which is under Priority Review for treating Classic Galactosemia. The PDUFA target action date is set for November 28, and the company is expected to launch the drug in 2025, with projected sales exceeding $1 billion by 2030.
September 18, 2024 | 2:52 pm
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Applied Therapeutics' stock surged 71.40% after the FDA decided not to hold an Advisory Committee meeting for its drug govorestat, which is under Priority Review. The drug is expected to launch in 2025, with sales potentially exceeding $1 billion by 2030.
The FDA's decision to not require an Advisory Committee meeting is a positive regulatory signal, suggesting confidence in the drug's approval process. This news, combined with the high unmet need in the galactosemia market and the potential for significant sales, has driven the stock price up significantly.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100