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 ...
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 ...
Wait for galactosemia therapy goes on after FDA shuns Applied Therapeutics’ govorestat
The US Food and Drug Administration (FDA) has declined to approve Applied Therapeutics’ govorestat for classic galactosemia, ...
pharmaphorum13h
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 ...
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 ...
Applied Therapeutics down 84% after receiving CRL from FDA on NDA for govorestat
In after-hours trading, shares are down 84% to $1.34.Don't Miss our Black Friday Offers:Unlock your investing potential with TipRanks Premium - ...
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 ...
FDA approves Kebilidi for aromatic L-amino acid decarboxylase deficiency
The U.S. Food and Drug Administration has approved PTC Therapeutics' Kebilidi (eladocagene exuparvovec-tneq) for the ...