APLT Applied Therapeutics Inc

By Colin Kellaher

Applied Therapeutics Inc. shares tumbled more than 25% in early trading Monday after the biopharmaceutical company reported further delays in its effort to seek U.S. Food and Drug Administration approval of its lead product candidate.

The New York company, which had been aiming to file its new drug application for AT-007 in the rare inherited disorder galactosemia by the end of last year, said it has put those plans on hold after the agency indicated that clinical outcomes data from an ongoing Phase 3 study will likely be required for approval.

Applied Therapeutics said it had previously been discussing the galactosemia program with the FDA in the context of the agency's accelerated approval program, which allows the use of surrogate endpoint and can considerably shorten the time required prior to receiving FDA approval for drugs that treat serious conditions and fill an unmet medical need.

The company said clinical outcomes in the Phase 3 study of AT-007 are assessed every six months, with the first assessment slated for completion in the first quarter. The assessments will continue every six months until the study reaches statistical significance.

Applied Therapeutics, which last year pushed its planned filing from the third quarter to the fourth quarter due to changes in the study, Monday said it was "disappointed by this change in direction by the FDA," and that it would work with the agency to determine the most expeditious path forward to approval of the drug.

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

Applied Therapeutics shares were recently changing hands at $6.65, down 25.7%, after hitting a 52-week low of $6 early in the session. The stock is more than 75% below the 52-week high of $29.80 it reached last February.

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

(END) Dow Jones Newswires

January 03, 2022 10:33 ET (15:33 GMT)

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