FDA, Applied

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 Crashes After FDA Rejection of Rare Disease Drug
After extending its review period to evaluate additional submissions, the FDA ultimately denied Applied Therapeutics’ govorestat for galactosemia, citing “deficiencies” with the application. The biotech plans to meet with the regulator to discuss the best way forward for the drug.
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% drop in the biotech’s share price. Applied said the complete response letter cited “deficiencies in the clinical application” but it plans to reapply or appeal.
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.
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.
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.
RBC downgrades Applied Therapeutics as FDA rejects Govorestat, hacks price target
RBC Capital Markets downgraded Applied Therapeutics Inc (NASDAQ:APLT) stock to "sector perform" from "outperform” citing increased risks after the U.S. Food and Drug Administration (FDA) rejected the company’s application for
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.
Applied Therapeutics downgraded to Neutral from Buy at UBS
UBS analyst Colin Bristow downgraded Applied Therapeutics (APLT) to Neutral from Buy with a price target of $2, down from $13.Don't Miss our ...
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 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 ...
Applied Therapeutics target lowered to $8, ‘catalyst watch’ removed at Citi
Citi analyst Yigal Nochomovitz lowered the firm’s price target on Applied Therapeutics (APLT) to $8 from $13 and keeps a Buy rating on the ...
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 resubmission or appeal.
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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 ...
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Applied Tx craters as FDA rejects lead product candidate
In a statement, Applied Tx said it is reviewing the complete response letter (CRL) from the FDA and "plans to immediately ...