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Why Is Applied Therapeutics Stock Trading Higher Today? - Applied Therapeutics (NASDAQ:APLT)

Applied Therapeutics surges as FDA grants Priority Review to govorestat (AT-007) for Galactosemia treatment. If approved, it would be the first medication for Galactosemia. APLT also submits MAA to EMA, with a decision expected in Q4 2024. Private placement of $100 million. ....

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Applied Therapeutics' NDA For Govorestat Gets Priority Review From FDA; Stock Soars In Pre-Market

Applied Therapeutics, Inc. (APLT), Wednesday announced that the U.S. Food and Drug Administration had accepted the filing of the New Drug Application or NDA for Govorestat for the treatment of galactosemia and granted a priority review. ....

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FDA Grants Review Date For Applied Therapeutics' First Commercial Product For Rare Metabolic Disorder

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 ....

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Why Is Applied Therapeutics Stock Trading Higher Today?

Why Is Applied Therapeutics Stock Trading Higher Today?
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Mirum Pharmaceuticals Announces Preliminary Unaudited 2023 Net Revenue and Provides Corporate Updates

- $186-188 million in total revenue and $178-180 million net product sales expected for 2023, preliminary and unaudited

- LIVMARLI net products sales of $141-143 million expected for 2023,. ....

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