Applied Therapeutics, Inc. (APLT), Wednesday announced that the U.S. Food and Drug Administration had accepted the filing of the New Drug Application or NDA for Govorestat for the treatment of galactosemia and granted a priority review.
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
Shares of Applied Therapeutics, Inc. (APLT) are surging more than 40 percent Wednesday morning after the clinical-stage biopharmaceutical company announced a private placement to the tune of $100 million.
Applied Therapeutics Shares Surge on FDA Review, $100 Million Funding Round morningstar.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from morningstar.com Daily Mail and Mail on Sunday newspapers.
Shares of Applied Therapeutics, Inc. (APLT) are surging more than 40 percent Wednesday morning after the clinical-stage biopharmaceutical company announced a private placement to the tune of $100 million.
Allarity Therapeutics (NASDAQ:ALLR – Get Free Report) and Applied Therapeutics (NASDAQ:APLT – Get Free Report) are both small-cap medical companies, but which is the superior investment? We will compare the two businesses based on the strength of their profitability, institutional ownership, dividends, risk, analyst recommendations, earnings and valuation. Analyst Recommendations This is a summary of […]
Based on positive phase III study data, Applied Therapeutics Inc. plans to take its CNS-penetrant aldose reductase inhibitor to the U.S. FDA to talk about an NDA for treating the rare disease sorbitol dehydrogenase (SORD) deficiency. SORD, a hereditary axonal neuropathy created by sorbitol dehydrogenase gene mutations, affects about 3,300 people in the U.S. and about 4,000 in Europe, according to Applied Therapeutics.
This randomized trial compares the effect of intermediate-dose vs standard prophylactic enoxaparin on a composite outcome of acute venous thromboembolism (VTE),
Applied Therapeutics, Inc. announced positive interim 12-month results from the ongoing Phase 3 INSPIRE trial, in which the primary endpoints and several key secondary endpoints were achieved. The...