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 ...
With issues in therapy delivery and a barren trial landscape, short-term chances for a commercial galactosemia treatment are ...
Shares in Applied Therapeutics have lost more than 80% of their value after the FDA turned down its marketing application for lead drug govorestat as a treatment for galactosaemia. The sell-off ...
NEW YORK, NY / ACCESS Newswire / February 14, 2025 / If you suffered a loss on your Applied Therapeutics, Inc. (NASDAQ:APLT) investment and want ...
What Happened? On November 27, 2024, Applied Therapeutics disclosed that it had received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the ...
February 14, 2025) - The law firm of Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Applied Therapeutics, Inc. (NASDAQ: APLT) securities between January 3, 2024 and ...
After market hours on December 2, 2024, Applied Therapeutics disclosed it received a “warning letter” from the FDA referring to the clinical trial issues underlying the CRL. Applied ...
Following a more than two-year-long hold, Entrada Therapeutics can get its Duchenne muscular dystrophy (DMD) candidate back on track. The company announced on Monday that the US Food and Drug ...
Detailed price information for Applied Therapeutics Inc (APLT-Q) from The Globe and Mail including charting and trades.
United Therapeutics said Monday that the Food and ... but those procedures were done through compassionate use waivers from the FDA that allow doctors to treat individual patients with no viable ...