FDA Grants Review Date For Applied Therapeutics' First Commercial Product For Rare Metabolic Disorder
Portfolio Pulse from Vandana Singh
Applied Therapeutics Inc (NASDAQ:APLT) shares surged after the FDA accepted the New Drug Application for govorestat (AT-007) for Classic Galactosemia, granting it Priority Review with a PDUFA date of August 28, 2024. The drug, potentially the first treatment for Galactosemia, also received Pediatric Rare Disease designation. Additionally, the company announced a $100 million private placement to fund govorestat commercial activities and other projects, expecting to sustain the business into 2026.
February 28, 2024 | 4:01 pm
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POSITIVE IMPACT
Applied Therapeutics Inc's stock surged following FDA's acceptance of govorestat (AT-007) for Priority Review, indicating strong potential for the company's first commercial product. The $100 million private placement will support its launch and further development.
The FDA's acceptance of govorestat (AT-007) for Priority Review is a significant positive development for Applied Therapeutics, indicating a high likelihood of approval. This, combined with the successful $100 million private placement, significantly boosts the company's financial position and prospects for launching its first commercial product. The positive interim results from the Phase 3 INSPIRE trial further support the drug's potential, contributing to the stock's surge.
CONFIDENCE 90
IMPORTANCE 95
RELEVANCE 100