Applied Therapeutics Provides Regulatory Update on Govorestat for the Treatment of Classic Galactosemia
Applied Therapeutics, Inc. (APLT)
Last applied therapeutics, inc. earnings: 11/13 07:00 am
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Source: GlobeNewswire
- Company completed Late-Cycle review meeting with FDA - FDA no longer intends to hold Advisory Committee meeting - FDA Review of NDA continues to proceed as planned with PDUFA target action date of November 28, 2024 NEW YORK, Sept. 18, 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 an update on the ongoing New Drug Application (NDA) review of govorestat for the treatment of Classic Galactosemia. The Company recently completed its late-cycle review meeting with the United States Food and Drug Administration (FDA). The FDA communicated that an Advisory Committee meeting would no longer be required, which was previously tentatively scheduled for October 9, 2024. The FDA informed the Company that the Priority Review of the NDA is continuing as planned with alignment on post-marke
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APLT
News
- Applied Therapeutics Reports Third Quarter 2024 Financial ResultsGlobeNewswire
- Applied Therapeutics to Present at the 2024 UBS Global Healthcare ConferenceGlobeNewswire
- Is Applied Therapeutics (APLT) Stock Outpacing Its Medical Peers This Year? [Yahoo! Finance]Yahoo! Finance
- All You Need to Know About Applied Therapeutics (APLT) Rating Upgrade to Buy [Yahoo! Finance]Yahoo! Finance
- APLT Stock Soars 69% on Positive Update on Galactosemia Drug NDA [Yahoo! Finance]Yahoo! Finance
APLT
Earnings
- 8/7/24 - Miss
APLT
Sec Filings
- 11/14/24 - Form SC
- 11/14/24 - Form SC
- 11/14/24 - Form SC
- APLT's page on the SEC website