Applied Therapeutics sinks after FDA declines to approve genetic disease drug

Applied Therapeutics

29/11/2024 11:15

** Shares of Applied Therapeutics  APLT.O  fall 70.3% to
$2.55 premarket
    ** The U.S. FDA on Wednesday declined to approve APLT's drug
to treat galactosemia, a rare genetic metabolic disease
    ** The FDA's letter cited "deficiencies in the clinical
application" for the drug, called govorestat, APLT says
    ** Brokerage William Blair says the letter was "unexpected
and disappointing" but believes it does not increase the
regulatory risk for govorestat's approval for SORD deficiency,
another rare genetic metabolic condition
    ** As of last close, stock has more than doubled YTD

 (Reporting by Kamal Choudhury)
 ((Kamal.Choudhury@thomsonreuters.com;))