Applied Therapeutics says it received FDA's warning letter for genetic disease drug study
Applied Therapeutics said on Monday it received a warning letter limited to a trial studying its genetic disease drug, after ...
FierceBiotech10h
Applied Therapeutics' trial conduct scrutinized in FDA warning letter
While Applied Therapeutics has vowed to reapply or appeal the FDA’s recent rejection of its rare disease candidate govorestat ...
BioSpace13h
FDA Warns Applied Therapeutics of ‘Objectionable Conditions’ in Govorestat Study
The agency’s warning letter outlines Applied Therapeutics’ failure to provide adequate information regarding the clinical ...
pharmaphorum16h
Warning letter adds to Applied Tx run of bad news
Applied Therapeutics has been sent a warning letter from the FDA over a clinical trial of its rare disease therapy govorestat ...
Applied Therapeutics Stock Plummets After FDA Rejects Metabolic Disease Drug
Applied Therapeutics' New Drug Application for a rare metabolic disease was rejected by the Food and Drug Administration, ...
BioSpace2d
Applied Therapeutics Crashes After FDA Rejection of Rare Disease Drug
After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ ...
Applied Therapeutics Stock Plummets 73%. The FDA Delivers This Crushing Blow.
The pharma company's shares are getting crushed after regulators decline to green light a drug to treat a rare disease.
FierceBiotech2d
FDA rejects Applied filing for rare disease approval on clinical grounds, sinking stock
The FDA has rejected Applied Therapeutics’ attempt to win approval on the strength of a failed phase 3 trial, triggering a 75 ...
Applied Therapeutics: FDA Denial Of Govorestat NDA As Problematic As It Was Unexpected
Applied Therapeutics faces challenges after FDA rejection, but future opportunities exist. Learn why APLT stock could recover ...
BioPharma Dive2d
Applied’s rare disease drug rejected by FDA
Executives at Applied Therapeutics told analysts they were surprised by the agency’s refusal to approve the company’s ...
Applied Therapeutics stock craters 75% on FDA setback
Applied Therapeutics stock (APLT) was down 75% early Friday on news the FDA had declined to approve its drug govorestat, ...
Optimistic Outlook for Applied Therapeutics Despite FDA Setback
Leerink Partners analyst Joseph Schwartz has maintained their bullish stance on APLT stock, giving a Buy rating on November 29.Don't Miss our ...