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Moleculin Receives Positive FDA Feedback on Pediatric Study Plan for Annamycin in Children with R/R AML

Annamycin aims to eliminate cardiotoxicity associated with anthracyclines used to treat about 60% of all children with cancer  FDA recommends inclusion of patients as young as 6 months – younger than Moleculin had proposed – to be allowed in the pediatric clinical study Enrollment and dosing are ongoing in pivotal, adaptive design Phase 3 MIRACLE trial of Annamycin in adult patients with R/R AML; Initial data readout is on track for the second half of 2025 HOUSTON, June 18, 2025 (GLOBE NEWSWIRE) -- Moleculi ...