Wait for galactosemia therapy goes on after FDA shuns Applied Therapeutics’ govorestat
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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.
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 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: 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 ...
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 ...
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APLT Stock Plunges 77% After FDA Issues CRL for Galactosemia Drug NDA
The NDA for govorestat for the galactosemia indication was accepted by the FDA in late February under its Priority Review pathway. Year to date, shares of Applied Therapeutics have skyrocketed ...
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, ...
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 ...
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 ...