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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 ...
MT Newswires on MSN1d
Applied Therapeutics' Govorestat Faces 'Significant' Uncertainty in Galactosemia Treatment After FDA Rejection, RBC Says
Applied Therapeutics' (APLT) lead drug candidate, govorestat, likely faces "significant" uncertainty in potentially treating galactosemia after the US Food and Drug Administration rejected the ...
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, ...
Wait for galactosemia therapy goes on after FDA shuns Applied Therapeutics’ govorestat
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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: 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 ...
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 ...
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
Govorestat, First and Only Potential Treatment for Classic Galactosemia, Does Not Receive FDA Approval
Galactosemia Foundation Urges FDA to Reconsider on Behalf of Rare Disease Community Facing Devastating Disease ALBANY, N.Y., Nov. 27, 2024 /PRNewswire/ -- The Galactosemia Foundation, a non ...
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 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 ...