FDA, Galactosemia and New Drug Application
Applied Therapeutics Receives Complete Response Letter from U.S. FDA Regarding New Drug Application for Govorestat for Classic Galactosemia
Govorestat is a central nervous system (CNS) penetrant Aldose Reductase Inhibitor (ARI) being developed for the treatment of multiple rare diseases including Classic Galactosemia, Sorbitol Dehydrogenase (SORD) Deficiency, and PMM2- congenital disorder of glycosylation (CDG).
Applied Therapeutics faces challenges after FDA rejection, but future opportunities exist. Learn why APLT stock could recover ...
Applied Therapeutics said on Wednesday that the U.S. FDA declined to approve its drug to treat galactosemia, a rare genetic ...
The US Food and Drug Administration has declined to approve Applied Therapeutics’ govorestat for classic galactosemia.
The sell-off started last night and continued in after-hours trading after the New York-based biopharma company revealed that ...
Applied Therapeutics (APLT) announced the FDA has issued a Complete Response Letter for the New Drug Application for govorestat, for ...
With two decisions originally scheduled for this week already announced, including BridgeBio's approval in ATTR-CM, the ...
Applied Therapeutics said it has received a complete response letter from the Food and Drug Administration related to its new drug application for govorestat due to deficiencies in the clinical ...
Applied Therapeutics has previously said it hoped to be able to file for accelerated FDA approval based on biomarker data showing that AT-007 was able to reduce levels of galactitol, the main ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback