Moleculin Biotech receives FDA feedback on pediatric study plan for Annamycin

Moleculin Biotech (MBRX) announced it has received a written response from the Office of Oncologic Diseases – Pediatric Oncology, of the U.S. Food and Drug Administration, FDA, regarding the Company’s Initial Pediatric Study Plan, iPSP, which was submitted after a June 2024 end-of-phase 1/2 meeting. The FDA has agreed to a single pediatric approval study in which Annamycin in combination with Cytarabine will be evaluated as second line therapy in pediatric patients with relapsed/refractory acute myeloid leukemia, R/R AML, a form of cancer. Enrollment and dosing are ongoing in the 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