While Applied Therapeutics has vowed to reapply or appeal the FDA’s recent rejection of its rare disease candidate govorestat ...
NEW YORK, NY / ACCESSWIRE / December 4, 2024 / Levi & Korsinsky notifies investors that it has commenced an investigation of Applied ...
The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical ...
Independent valuation of PsyLabs values Psyence Biomed’s stake at approximately $2 million, doubling in value. Debt-for-equity swap with Psyence Group and Newcourt SPAC Sponsor ...
Leerink Partners analyst Joseph Schwartz has maintained their bullish stance on APLT stock, giving a Buy rating on November 29.Don't Miss our ...
Applied Therapeutics said on Monday it received a warning letter limited to a trial studying its genetic disease drug, after ...
The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Applied Therapeutics regarding the New Drug Application (NDA) for govorestat for the treatment of classic ...
Novartis will partner with PTC Therapeutics to develop PTC’s PTC518 Huntington's disease program and an unspecified number of related molecules, through an up-to-$2.9 billion exclusive global license ...
Executives at Applied Therapeutics told analysts they were surprised by the agency’s refusal to approve the company’s ...
Shares of Applied Therapeutics (APLT) plummeted 76.3% after the FDA rejected approval for its drug intended to treat a rare genetic metabolic disorder. Target Corporation’s (TGT) shares jumped 1.7% on ...
After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ ...
The FDA has rejected Applied Therapeutics’ attempt to win approval on the strength of a failed phase 3 trial, triggering a 75 ...