Applied Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Govorestat for the Treatment of Classic Galactosemia [Yahoo! Finance]
Applied Therapeutics, Inc. (APLT)
Last applied therapeutics, inc. earnings: 11/13 07:00 am
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Source: Yahoo! Finance
NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of the New Drug Application (NDA) for govorestat (AT-007) for the treatment of 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 is planning to hold an advisory committee meeting to discuss the application. Govorestat was previously granted Pediatric Rare Disease designation, and will qualify for a Priority Review Voucher (PRV) upon approval. “The FDA's acceptance of the NDA for govorestat for the treatment of Galactosemia represents a critical milestone for Applied Therapeutics and more importantly,
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News
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- Applied Therapeutics to Present at the 2024 RBC Capital Markets Global Healthcare ConferenceGlobeNewswire
- Applied Therapeutics Appoints Dale Hooks as Chief Commercial Officer [Yahoo! Finance]Yahoo! Finance
- Applied Therapeutics Appoints Dale Hooks as Chief Commercial OfficerGlobeNewswire
APLT
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- 5/9/24 - Miss
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- 5/17/24 - Form 144
- 5/16/24 - Form 144
- 5/9/24 - Form 10-Q
- APLT's page on the SEC website