Why Applied Therapeutics Stock Is Skyrocketing Today [Yahoo! Finance]
Applied Therapeutics, Inc. (APLT)
Last applied therapeutics, inc. earnings: 11/13 07:00 am
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Source: Yahoo! Finance
ET on Wednesday. The huge gain came after the U.S. Food and Drug Administration (FDA) told the company that an Advisory Committee meeting to review the New Drug Application (NDA) for govorestat in treating galactosemia, a rare genetic metabolic disease, was no longer required. Originally, the FDA tentatively planned to hold an Advisory Committee meeting to review the NDA for govorestat on Oct. 9, 2024. Now, though, the agency believes it can make an approval decision on the drug without bringing in outside experts. The FDA set a PDUFA date of Nov. 28, 2024, for this decision. Why the scrapped AdCom meeting is such good news for Applied Therapeutics Advisory Committee meetings increase the risk that a drug will not be approved. Although the FDA doesn't have to go along with the recommendations from these committees, it usually does. Now that the Advisory Committee meeting for govorestat has been canceled, the likelihood that the drug will win FDA approval should be greater. Is
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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