The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical ...
Applied Therapeutics has been sent a warning letter from the FDA over a clinical trial of its rare disease therapy govorestat ...
After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ ...
While Applied Therapeutics has vowed to reapply or appeal the FDA’s recent rejection of its rare disease candidate govorestat ...
Applied Therapeutics said on Monday it received a warning letter limited to a trial studying its genetic disease drug, after ...
NEW YORK, NY / ACCESSWIRE / December 4, 2024 / Levi & Korsinsky notifies investors that it has commenced an investigation of Applied ...
The pharma company's shares are getting crushed after regulators decline to green light a drug to treat a rare disease.
Applied Therapeutics' New Drug Application for a rare metabolic disease was rejected by the Food and Drug Administration, ...
Applied Therapeutics stock (APLT) was down 75% early Friday on news the FDA had declined to approve its drug govorestat, ...
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 faces challenges after FDA rejection, but future opportunities exist. Learn why APLT stock could recover ...
Fintel reports that on December 2, 2024, UBS downgraded their outlook for Applied Therapeutics (NasdaqGM:APLT) from Buy to ...