NEW YORK, June 15, 2020 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular ...

NEW YORK, March 16, 2022 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated ...

Submissions are based on positive results from Phase 3 registrational ACTION-Galactosemia Kids study demonstrating consistent long-term clinical outcomes benefit across a range of functional measures ...

The NDA could not be approved at this time due to deficiencies in the clinical application. The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Applied Therapeutics ...

Pre-NDA Meeting to be held with FDA this summer to discuss potential NDA submission for govorestat (AT-007) for treatment of Classic Galactosemia EMA Marketing Authorization Application for govorestat ...

- Preclinical studies support continued development of JAG101, an investigational gene therapy designed to address the root cause of Type 1 galactosemia and reduce multiple toxic metabolites - ...

Investors hoped the positive biomarker data that AT-007 produced in September would support accelerated approval for the treatment of galactosemia. The FDA is not as impressed with the company's ...

London: The U.S. Food and Drug Administration has extended its review of Applied Therapeutics' experimental drug to treat galactosemia, a rare genetic metabolic disease, the company said on Thursday.

Fifty-five individuals participated in the evaluation of a simplified, noninvasive breath test. Subjects included 13 normal controls and 42 patients with galactosemia. Data on these subjects were used ...

NEW YORK, June 15, 2020 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated ...