By George Glover
Applied Therapeutics stock was tanking Friday after regulators said they were unable to green light a drug to treat a rare genetic disease.
Shares in the biotech company plunged 73% to $2.33, wiping out $730 million in valuation. The small-cap Russell 2000 index was up 0.6%.
The massive losses came after Applied Therapeutics said it had received a letter from the Food and Drug Administration in which the agency declined to approve a drug to treat the metabolic disorder Classic Galactosemia. The company said the FDA had cited "deficiencies in the clinical application" of the drug, which it's marketing as govorestat.
Founder and CEO Shoshana Shendelman said she was "disappointed by the FDA's decision," adding that Applied Therapeutics would "work with the FDA to address the concerns" raised in its letter.
It looks like a crushing blow for the stock. As of Wednesday's close, shares in Applied Therapeutics were up 135% in 2024, but Friday's losses mean they're now trading in the red for the year.
Write to George Glover at george.glover@dowjones.com
This content was created by Barron's, which is operated by Dow Jones & Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal.
(END) Dow Jones Newswires
November 29, 2024 10:48 ET (15:48 GMT)
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