APLT - Applied Therapeutics to resume galactosemia study for AT-007

Applied Therapeutics (APLT) rose yesterday after the company announced that the FDA lifted hold for ACTION-Galactosemia Kids pediatric clinical study for AT-007.The company expects to immediately resume the study with a target of completing the enrollment within weeks, as patients who were already randomized in the trial will be eligible to return to the study.Two dose escalation and biomarker phases have now been combined into a single two-part study, and all participants who complete both studies will seamlessly continue into the long-term outcomes study without treatment interruption.Additionally, the dose-escalation portion of the study has been modified to ensure continuous drug treatment and participation throughout the study. Applied Therapeutics is targeting an NDA filing by Q3 2021.In August, the company announced that the FDA placed a partial clinical hold on its ACTION-Kids study that evaluated AT-007, an Aldose Reductase inhibitor, for the treatment of galactosemia.

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Applied Therapeutics to resume galactosemia study for AT-007