BioSpace15h
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 ...
FierceBiotech12h
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 ...
Monthly Prescribing Reference2d
FDA Denies Approval of Govorestat for Classic Galactosemia
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 ...
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 ...
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 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 ...
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 ...
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’ ...
RBC says if Applied’s govorestat were to be approved, would likely hear today
PDUFA for govorestat is tomorrow, November 28th, though given that the day falls on a holiday, there is some uncertainty around when a potential decision could be announced. The firm’s analysis of ...
Wait for galactosemia therapy goes on after FDA shuns Applied Therapeutics’ govorestat
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Zacks.com on MSN6d
APLT Stock Plunges 77% After FDA Issues CRL for Galactosemia Drug NDA
Applied Therapeutics APLT announced that the FDA has issued a Complete Response Letter (CRL) for the new drug application ...