Therapeutics, Food and Drug Administration

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 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.
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%.
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’ NDA for govorestat receives negative response from FDA
Applied Therapeutics (APLT) announced that the FDA has issued a Complete Response Letter – CRL – for the New Drug Application – NDA – for
Applied Therapeutics Receives FDA Complete Response Letter for Govorestat New Drug Application
Applied Therapeutics said it has received a complete response letter from the Food and Drug Administration related to its new drug application for govorestat due to deficiencies in the clinical application.
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 Therapeutics stock craters 75% on FDA setback
Applied Therapeutics shares (NASDAQ:APLT) were down 75% early Friday, the first trading session after the company ...
pharmaphorum2d
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 ...
Biopharmaceutical Company's Stock Plunges 75% After FDA Rejects New Drug
Applied Therapeutics' stock plummeted 75 percent after the Food and Drug Administration (FDA) rejected approving govorestat ...
Applied Therapeutics CRL a ‘major setback,’ says William Blair
William Blair says Applied Therapeutics (APLT)’ complete response letter from the FDA for govorestat for the treatment of galactosemia is “unexpected and disappointing.” Given the lack of information ...
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 ...
Nasdaq2d
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 (NDA) seeking approval for APLT’s lead candidate, govorestat ...