By Colin Kellaher

Applied Therapeutics shares rose sharply and hit a new 52-week high on Wednesday after the clinical-stage biopharmaceutical company reported a pair of regulatory advances for its lead product candidate.

Shares of the New York company were recently changing hands at $3.98, up 9.2%, after touching a 52-week high of $4.42 earlier in the session.

Applied said it filed last month for U.S. Food and Drug Administration approval of govorestat for the treatment of classic galactosemia, a rare genetic metabolic disease for which there is currently no available treatment.

The company also said the European Medicines Agency has validated and accepted for review its application seeking approval of the drug in the European Union.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

January 03, 2024 11:05 ET (16:05 GMT)

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