By Colin Kellaher

Applied Therapeutics Inc. on Monday said it is again delaying plans to seek U.S. Food and Drug Administration approval of its AT-007 drug candidate for the genetic disorder galactosemia.

The New York clinical-stage biopharmaceutical company said the FDA has now indicated that clinical-outcomes data will likely be required for approval.

Applied Therapeutics, which in September had said it was delaying filing a new-drug application until the fourth quarter because of study changes, on Monday said it is holding off on the submission pending further talks with the FDA.

Applied Therapeutics' continuing Phase 3 study is evaluating the impact of AT-007 treatment versus placebo on clinical outcomes over time, with assessments every six months. The company said the first assessment will be completed in the first quarter, and then every six months thereafter until the study reaches statistical significance.

The company said it had been discussing AT-007 in terms of accelerated approval with the FDA and that it is disappointed with what it called a change in direction by the agency. Applied Therapeutics said it plans to work with the FDA to determine the most expeditious path forward to regulatory approval.

There are currently no drugs approved for galactosemia, a rare inherited disorder that hinders the body's ability to process and produce energy from a sugar called galactose.

Trading in Applied Therapeutics was halted premarket Monday.

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

(END) Dow Jones Newswires

January 03, 2022 07:46 ET (12:46 GMT)

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