APLT Stock Soars 69% on Positive Update on Galactosemia Drug NDA [Yahoo! Finance]
Applied Therapeutics, Inc. (APLT)
Last applied therapeutics, inc. earnings: 11/13 07:00 am
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Source: Yahoo! Finance
Shares of Applied Therapeutics APLT surged 68.8% on Wednesday after it announced a regulatory update regarding the ongoing new drug application (NDA) review of APLT's lead candidate, govorestat, for treating classic galactosemia. Per the press release, in a late-cycle review meeting with the FDA, the regulatory body communicated to Applied Therapeutics that it no longer requires the opinion of an Advisory Committee. The Advisory Committee meeting was previously tentatively scheduled for Oct. 9, 2024. APLT's govorestat (also known as AT-007) is a novel central nervous system penetrant ARI, which is currently being developed for three rare neurological diseases. The NDA for govorestat for the galactosemia indication was accepted by the FDA in late February under its Priority Review pathway. A filing designated as a Priority Review reduces the review period by four months. A final decision from the regulatory body was originally expected on Aug. 28, 2024. However, in March 2024, A
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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
- Applied Therapeutics, Inc. (NASDAQ: APLT) had its price target raised by analysts at Citigroup Inc. from $8.00 to $11.00. They now have a "buy" rating on the stock.MarketBeat
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