Applied Therapeutics Delays Plans to Seek FDA Approval of AT-007
January 03 2022 - 8:01AM
Dow Jones News
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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