FDA extends the review period for Applied Therapeutics' NDA for govorestat, targeting Classic Galactosemia treatment. The new action date is set for November 28, 2024. Applied Therapeutics anticipates a decision from EMA in Q4 2024.
FDA Presses Delay Button For Applied Therapeutics' First Potential Marketed Drug For Rare Disease biztoc.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from biztoc.com Daily Mail and Mail on Sunday newspapers.
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
Why Is Applied Therapeutics Stock Trading Higher Today? biztoc.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from biztoc.com Daily Mail and Mail on Sunday newspapers.
In this article, we will take a detailed look at the 13 Best Booming Stocks to Buy Right Now. For a quick overview of such stocks, read our article 5 Best Booming Stocks to Buy Right Now. Despite latest data showing elevated inflation and a decline in retail sales, some major investment firms are looking beyond the short-term market […]
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Applied Therapeutics Inc APLT shares are trading higher after the company, on Thursday, released interim 12-month results from the ongoing Phase 3 INSPIRE…
Applied Therapeutics Inc APLT released topline results of the ARISE-HF Phase 3 trial of AT-001 (caficrestat) in patients with Diabetic Cardiomyopathy (DbCM)…
Applied Therapeutics Inc (NASDAQ: APLT)’s stock price has soared by 10.11 in relation to previous closing price of 2.22. Nevertheless, the company has seen a loss of -2.78% in its stock price over the last five trading days. GlobeNewsWire reported 2023-09-28 that The ongoing ARISE-HF Phase 3 g
Applied Therapeutics Inc (NASDAQ: APLT)’s stock price has decreased by -8.44 compared to its previous closing price of 2.43. However, the company has seen a -15.72% decrease in its stock price over the last five trading sessions. GlobeNewsWire reported 2023-09-28 that The ongoing ARISE-HF Phase 3