Applied Therapeutics Stock Drops On Delayed NDA Submission For Its Lead Candidate

Applied Therapeutics Inc APLT has reported initial biomarker data from the pediatric ACTION-Galactosemia Kids study and baseline analysis of the 47 children enrolled in the study.
Related Content: FDA Fast Track Review For AT-007 In Rare Metabolic Disorder.
Galactosemia is a condition in which the body cannot use (metabolize) the simple sugar galactose.
Pharmacokinetic analysis of AT-007 plasma drug levels at day 30 revealed that dosing could be further optimized by adjusting dose based on weight rather than age.
The Company expects to present additional biomarker data at the optimized drug levels. Due to the changes, the Company now plans to submit a US marketing application in Q4 of 2021, against Q3 of 2021.
Biomarker results demonstrate a substantial reduction in plasma galactitol of approximately 35% after 30 days of treatment, which was statistically significant vs. placebo.
AT-007 was safe and well-tolerated in children of all ages (2-17). Additionally, analysis of the 47 children in the ACTION-Galactosemia Kids study demonstrated a clear correlation between baseline galactitol level and baseline clinical, functional outcomes.
Complete data will be presented at a future medical conference.
Price Action: APLT shares are down 1.90% at $15.01 during the market session on the last check Thursday.