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: 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 ...
Wait for galactosemia therapy goes on after FDA shuns Applied Therapeutics’ govorestat
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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: FDA Issues CRL For New Drug Application For Govorestat - Quick Facts
Applied Therapeutics (APLT) announced the FDA has issued a Complete Response Letter for the New Drug Application for govorestat, for ...
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APLT Stock Plunges 77% After FDA Issues CRL for Galactosemia Drug NDA
Applied Therapeutics stock plummets 77% after the FDA issues a CRL for the company's NDA seeking approval for govorestat to treat classic galactosemia.
pharmaphorum12h
Applied Tx craters as FDA rejects lead product candidate
The sell-off started last night and continued in after-hours trading after the New York-based biopharma company revealed that ...
Applied Therapeutics Down 76% After Hours on FDA Complete Response Letter
An FDA complete response letter indicates that an application can't be approved in its current form. Govorestat, the company's lead drug candidate, is also being developed for treatment of sorbitol ...
BioSpace3d
FDA Action Alert: Applied Therapeutics Awaits Verdict on Rare Disease Therapy
With two decisions originally scheduled for this week already announced, including BridgeBio's approval in ATTR-CM, the ...
The Pharma Letter7h
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 ...
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 ...
Here are 4 biotech stocks that could get a boost from a more open FDA regulatory climate
Own stocks of companies that get drugs approved. That hasn’t been so easy. But the U.S. Food & Drug Administration (FDA) has ...