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, ...
Applied Therapeutics Receives Complete Response Letter from U.S. FDA Regarding New Drug Application for Govorestat for Classic Galactosemia
Govorestat is a central nervous system (CNS) penetrant Aldose Reductase Inhibitor (ARI) being developed for the treatment of multiple rare diseases including Classic Galactosemia, Sorbitol ...
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 ...
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 ...
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 ...
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 ...
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Applied Therapeutics Receives Complete Response Letter from FDA for Govorestat New Drug Application for Classic Galactosemia
Applied Therapeutics, Inc. announced that the FDA has issued a Complete Response Letter regarding their New Drug Application for govorestat, a treatment for Classic Galactosemia. The letter ...
Morningstar3d
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 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 ...
Morningstar3d
Applied Therapeutics Down 76% After Hours on FDA Complete Response Letter
Applied Therapeutics shares dropped after hours after disclosing that the Food and Drug Administration issued a complete response letter for its new drug application for govorestat for treatment ...
Applied Therapeutics plunges 83% following Complete Response Letter
The FDA has declined to approve Applied Therapeutics' govorestat, its candidate for the rare metabolic disorder classic ...
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 ...