Applied Therapeutics stock craters 75% on FDA setback
Applied Therapeutics stock (APLT) was down 75% early Friday on news the FDA had declined to approve its drug govorestat, ...
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, ...
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 ...
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RBC Capital Downgrades Applied Therapeutics (APLT)
Fintel reports that on November 29, 2024, RBC Capital downgraded their outlook for Applied Therapeutics (NasdaqGM:APLT) from ...
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: 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 ...
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 ...
Applied Therapeutics downgraded to Sector Perform from Outperform at RBC
RBC Capital analyst Brian Abrahams downgraded Applied Therapeutics (APLT) to Sector Perform from Outperform with a price target of $4, down ...
Applied Therapeutics price target lowered to $5 from $14 at Baird
Baird analyst Brian Skorney lowered the firm’s price target on Applied Therapeutics (APLT) to $5 from $14 and keeps an Outperform rating on the ...
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 ...
Nasdaq2d
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 (NDA) seeking approval for APLT’s lead candidate, govorestat ...