FierceBiotech10d
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 ...
TMCnet14h
The Law Offices of Frank R. Cruz Announces Investigation of Applied Therapeutics, Inc. (APLT) on Behalf of Investors
The Law Offices of Frank R. Cruz announces an investigation of Applied Therapeutics, Inc. ("Applied Therapeutics" or the "Company") (NASDAQ: APLT) on behalf of investors concerning the Company's ...
BioSpace10d
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’ ...
BioSpace8d
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 ...
The Pharma Letter13d
Applied Thera tanks, as FDA slaps CRL on govorestat NDA
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for ...
FDA Rejects Applied Therapeutics' NDA for Govorestat, Citing Flaws; Shares Plunge 76%
Applied Therapeutics ( APLT, Financials) announced that the U.S. Food and Drug Administration issued a Complete Response ...
FierceBiotech7d
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 ...
Endocrinology Advisor3d
FDA Denies Approval of Govorestat for Classic Galactosemia
The FDA has issued a Complete Response Letter regarding the NDA for govorestat for the treatment of classic galactosemia.
BioPharma Dive9d
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 ...
bovnews12d
Stock Slump or Stepping Stone? What’s Next for Applied Therapeutics (APLT) After FDA’s Latest Blow
This sharp decline in the company’s stock raises several questions about its future prospects, especially given the positive momentum it had been building throughout the year. Let’s delve into what ...
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, ...