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, to treat classic galactosemia.
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, causing its shares to crater Friday.
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, prompting a downgrade by RBC Capital. Read more here.
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 Letter regarding its New Drug Application for govorestat, a treatment for Classic Galactosemia; the stock closed at $2.03, down 76.3%.
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 resubmission or appeal.
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 with other potential approvals.
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
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 as a treatment for galactosemia.
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 ...
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 ...
Biotech Stock Roundup: BBIO Stock Up on Drug Approval, SAVA, APLT Plunge on Setbacks & More
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Unusually active option classes on open November 29th
Unusual total active option classes on open include: Kellogg ( K ), Outlook Therapeutics Inc ( OTLK ), Regions Financial ( RF ), Applied Therapeutics ( APLT ), First Solar ( FSLR ), Direxion Daily ...