Applied Therapeutics Stock Soars As FDA Scraps Panel Meeting For Its Inherited Metabolic Disorder Drug [Yahoo! Finance]
Applied Therapeutics, Inc. (APLT)
Last applied therapeutics, inc. earnings: 11/13 07:00 am
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Source: Yahoo! Finance
a session volume of 31.75 million, compared to an average volume of 1.26 million, according to data from Benzinga Pro The company announced an update on the ongoing New Drug Application (NDA) review of govorestat for Classic Galactosemia Galactosemia is an inherited metabolic disorder that makes the body unable to process a sugar called galactose. The company recently completed its late-cycle review meeting with the FDA, and the agency communicated that an Advisory Committee meeting, previously tentatively scheduled for October 9, would no longer be required. The FDA informed the company that the Priority Review of the NDA is continuing as planned, with alignment on post-marketing requirements expected in October 2024. The previously announced Prescription Drug User Fee Act (PDUFA) target action date remains on track for November 28. In April, the FDA extended the review period for Applied Therapeutics' marketing application, seeking approval for its potentially first mark
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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