Applied Therapeutics Shares Rise 11% After Pre-NDA Meeting With FDA
September 06 2023 - 10:08AM
Dow Jones News
By Chris Wack
Applied Therapeutics shares were up 11% to $1.40 after the
company successfully completed a recent pre-New Drug Application
meeting with the U.S. Food and Drug Administration regarding its
govorestat Galactosemia program.
The stock hit its 52-week high of $2.18 on May 1, and is down 1%
in the past 12 months.
Based on discussions with the FDA, the biopharmaceutical company
believes it is aligned with the FDA and plans to submit an NDA for
govorestat for the treatment of Galactosemia in the fourth
quarter.
Applied Therapeutics said the FDA expressed its support for a
potential NDA based on the govorestat data generated to date in
Galactosemia, and provided constructive recommendations for
successful NDA acceptance and review.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
September 06, 2023 10:53 ET (14:53 GMT)
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