(RTTNews) – Shares of Applied Therapeutics Inc. (APLT) are losing more than 17 percent or $4.99 in Monday’s morning trade at $24.25.
The company disclosed in a regulatory filing that on August 14, the U.S. Food and Drug Administration or FDA that placed a partial clinical hold on the ACTION-Kids Study and requested the company to provide additional technical information relating to ensuring that every patient in the study has access to the prospect of direct benefit of the drug. The company plans to submit the supporting technical information requested by the agency as soon as possible.
In June, Applied Therapeutics announced the initiation of the ACTION-Galactosemia Kids pediatric registrational study of AT-007 for treatment of galactosemia to evaluate safety, pharmacokinetics, and reduction in the toxic biomarker, galactito.
Applied Therapeutics has traded in a range of $9.01 to $57.39 in the past 52 weeks.
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