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

·1 min read
  • Applied Therapeutics Inc (NASDAQ: 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.

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