Applied Therapeutics, Inc. (APLT)
- Reuters
UPDATE 1-US FDA extends review of Applied Therapeutics' genetic disease drug
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. There are currently no approved treatments for the disease in the United States, which has about 3,000 Galactosemia patients. The FDA delayed its decision on the drug, govorestat, saying it requires additional time to review supplemental analyses submitted by the company.
- Zacks
Applied Therapeutics (APLT) Surges 124% in a Month: Here's Why
Applied Therapeutics (APLT) surges 124% in a month due to encouraging updates from two separate developmental programs for govorestat to treat different rare neurological indications.
- Benzinga
FDA Grants Review Date For Applied Therapeutics' First Commercial Product For Rare Metabolic Disorder
Applied Therapeutics Inc (NASDAQ:APLT) shares are trading higher on Wednesday after the FDA accepted the filing of the New Drug Application (NDA) for govorestat (AT-007) for Classic Galactosemia. The NDA was granted Priority Review status, and the FDA assigned a Prescription Drug User Free Act (PDUFA) target action date of August 28, 2024. The FDA also noted that it plans to hold an advisory committee meeting to discuss the application. Govorestat was previously granted Pediatric Rare Disease de
