FDA extends the review period for Applied Therapeutics' NDA for govorestat, targeting Classic Galactosemia treatment. The new action date is set for November 28, 2024. Applied Therapeutics anticipates a decision from EMA in Q4 2024.
FDA Presses Delay Button For Applied Therapeutics First Potential Marketed Drug For Rare Disease biztoc.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from biztoc.com Daily Mail and Mail on Sunday newspapers.
Applied Therapeutics Inc (NASDAQ:APLT) shares are trading higher on Wednesday after the FDA accepted the filing of the New Drug Application (NDA) for govorestat (AT-007) for Classic Galactosemia. The NDA was granted Priority Review status, and the FDA assigned a Prescription Drug User Free Act (PDUFA) target action date of August 28, 2024. The FDA also noted that it plans to hold an advisory committee meeting to discuss the application. Govorestat was previously granted Pediatric Rare Disease de
Why Is Applied Therapeutics Stock Trading Higher Today? biztoc.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from biztoc.com Daily Mail and Mail on Sunday newspapers.
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