Applied Therapeutics Stock Plummets

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 the U.S. health regulator declined to approve the treatment last week.
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, causing its shares to crater Friday.
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 treatment for classic galactosemia.
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, prompting a downgrade by RBC Capital. Read more here.
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 metabolic disease, casting a cloud over the company's hopes for its first commercial product.
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 Letter regarding its New Drug Application for govorestat, a treatment for Classic Galactosemia; the stock closed at $2.03, down 76.3%.
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 with other potential approvals.
Wait for galactosemia therapy goes on after FDA shuns Applied Therapeutics’ govorestat
The US Food and Drug Administration has declined to approve Applied Therapeutics’ govorestat for classic galactosemia.
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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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 ...
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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 ...
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 ...