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 ...
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, ...
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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 ...
RBC downgrades Applied Therapeutics as FDA rejects Govorestat, hacks price target
RBC Capital Markets downgraded Applied Therapeutics Inc (NASDAQ:APLT) stock to "sector perform" from "outperform” citing ...
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 ...
Wait for galactosemia therapy goes on after FDA shuns Applied Therapeutics’ govorestat
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RBC says if Applied’s govorestat were to be approved, would likely hear today
PDUFA for govorestat is tomorrow, November 28th, though given that the day falls on a holiday, there is some uncertainty around when a potential decision could be announced. The firm’s analysis of ...
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 ...
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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 ...
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 ...