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 ...
Biotech Stock Roundup: BBIO Stock Up on Drug Approval, SAVA, APLT Plunge on Setbacks & More
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Fintel on MSN1d
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 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 ...
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 ...
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, ...
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, ...
Futures gain before shortened Black Friday session
(Reuters) -U.S. stock futures rose ahead of a curtailed trading session on Black Friday, with Wall Street's main indexes set for monthly gains as the holiday shopping season kicked off, turning 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 ...
The Pharma Letter2d
Applied Thera tanks, as FDA slaps CRL on govorestat NDA
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for ...
APLT Stock Plunges 77% After FDA Issues CRL for Galactosemia Drug NDA
Applied Therapeutics stock plummets 77% after the FDA issues a CRL for the company's NDA seeking approval for govorestat to treat classic galactosemia.