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 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, ...
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, ...
US FDA declines to approve Applied Therapeutics' genetic disease drug
Applied Therapeutics said on Wednesday that the U.S. FDA declined to approve its drug to treat galactosemia, a rare genetic ...
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.
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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: 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 ...
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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’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 ...
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 ...
Regulatory Setback For Applied Therapeutics' Lead Program, FDA Highlights Deficiencies In Clinical Application
FDA rejected Applied Therapeutics' Govorestat for galactosemia, citing NDA deficiencies. The company plans discussions for ...
Soleno Therapeutics weakness a buying opportunity, says Baird
Baird noted Soleno Therapeutics (SLNO) shares have traded, directionally, with Applied Therapeutics shares over the last couple of trading ...