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Investing.com — Applied Therapeutics (NASDAQ:APLT) dropped almost 17% on Monday after disclosing that the U.S. Food and Drug Administration has place a partial clinic hold on its ACTION-Kids study.
The FDA has requested additional technical information relating to ensuring that every patient has access to the drug’s benefits. The study is currently in the dose range finding segment, and the partial clinical hold does not introduce any disruption to ongoing treatment.
The ACTION-Galactosemia Kids pediatric registrational study of AT-007 for treatment of galactosemia is meant to evaluate safety, pharmacokinetics, and reduction in the toxic biomarker, galactitol. The study is comprised of a placebo-controlled dose range finding segment evaluating up to seven days of consecutive dosing to determine the optimal dose in children, followed by a placebo-controlled 90-day study evaluating safety and biomarker efficacy.
The company will work closely with the FDA to resume the study as soon as possible.
Shares are down by more than half since hitting a 2020 high in February.
Earlier this month, Applied Therapeutics reported a loss per share of $1.27, compared to the expected loss of 69 cents per share.
