Why Applied Therapeutics Shares Are Falling Today

Applied Therapeutics APLT is trading significantly lower Monday after the company said it would not immediately submit a new drug application for its AT-007 for treatment of galactosemia.

The Galactosemia program had previously been discussed in the context of an NDA for accelerated approval based on reduction in galactitol, but the FDA has now indicated that clinical outcomes data will likely be required for approval.

The first assessment will be completed in the first quarter and then every 6 months after until the study reaches statistical significance.

"While disappointed by this change in direction by the FDA, we remain committed to bringing this important treatment to patients with Galactosemia," said Shoshana Shendelman, founder and CEO of Applied Therapeutics. "We will continue to work with the FDA to determine the most expeditious path forward to regulatory approval and will provide an update on timing and plans accordingly."

Applied Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need.

See Also: Why Nio Shares Are Rising Today

APLT Price Action: Applied Therapeutics has traded as high as $29.80 over a 52-week period. It's making new 52-week lows Monday.

The stock was down 30.4% at $6.23 at time of publication.