Applied Therapeutics: Speedy Regulatory Review Of Govorestat Might Be Possible [Seeking Alpha]
Applied Therapeutics, Inc. (APLT)
Last applied therapeutics, inc. earnings: 11/13 07:00 am
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Source: Seeking Alpha
Pre-NDA meeting with FDA to be sought out after to see if an NDA submission of govorestat for SORD deficiency could be done with only the positive 12-month interim data. 24-month interim results from the phase 3 INSPIRE study, using govorestat for the treatment of patients with SORD deficiency, is the next data readout to be expected. The NDA of govorestat for galactosemia has been submitted by the FDA and the EMA has validated the MAA; There is a good chance that Applied Therapeutics could receive regulatory approval for one or both of these territories. Looking for a portfolio of ideas like this one? Members of Biotech Analysis Central get exclusive access to our subscriber-only portfolios. Learn More » Applied Therapeutics NASDAQ: APLT announced positive 12-month interim results from its phase 3 INSPIRE study using AT-007 for the treatment of patients with Sorbitol dehydrogenase deficiency [SORD deficiency]. The last time I spoke about this biotech, I noted that it had sev
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APLT
News
- Applied Therapeutics Reports First Quarter 2024 Financial Results [Yahoo! Finance]Yahoo! Finance
- Applied Therapeutics Reports First Quarter 2024 Financial ResultsGlobeNewswire
- 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
Earnings
- 5/9/24 - Miss
APLT
Sec Filings
- 5/17/24 - Form 144
- 5/16/24 - Form 144
- 5/9/24 - Form 10-Q
- APLT's page on the SEC website