HOUSTON, June 18, 2025 - Moleculin Biotech, Inc., a late-stage pharmaceutical company focusing on difficult-to-treat cancers and viral infections, has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its Initial Pediatric Study Plan (iPSP) for Annamycin in combination with Cytarabine (AnnAraC) for pediatric patients with relapsed/refractory acute myeloid leukemia (R/R AML). The FDA has agreed to a single pediatric approval study and recommended the inclusion of patients as young as 6 months old, which is younger than Moleculin's original proposal. This study will evaluate the pharmacokinetics, efficacy, and safety of AnnAraC. Moleculin plans to update its iPSP and submit the revised plan later this quarter, with the pediatric clinical study anticipated to begin in the second half of 2027. Additionally, Annamycin has been granted Fast Track Status and Orphan Drug Designation by the FDA, and an Orphan Drug Designation by the European Medicines Agency for treating R/R AML.
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