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 ...

LOS ANGELES, CA / ACCESS Newswire / February 15, 2025 / The Schall Law Firm, a national shareholder rights litigation firm, reminds investors of ...

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 ...

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 ...

Detailed price information for Applied Therapeutics Inc (APLT-Q) from The Globe and Mail including charting and trades.

(“Applied Therapeutics”) (NASDAQ ... created an exceedingly severe risk that the trial data would be rejected by the FDA in the context of a New Drug Application. Please CLICK HERE to view ...

2018 saw a breakthrough in the field of RNA interference (RNAi), when the US FDA approved the first drug ... and five more approved drugs later, RNAi therapeutics are a proven class of medicines ...