FDA agrees to single pediatric study for Moleculin's Annamycin in pediatric R/R AML

Moleculin Biotech, Inc.

FDA accepted single-arm pediatric approval study of AnnAraC as second-line therapy in R/R AML aged 6 months+.
FDA recommended including patients from 6 months (Moleculin proposed 2-16 years); no minimum count for 6mo-2yr.
FDA said comparable PK/safety data could allow efficacy extrapolation from adults; pediatric trial can start before full 2-year adult follow-up.
Company to submit revised iPSP later this quarter; expects to initiate pediatric study in H2 2027.
Pivotal Phase 3 MIRACLE adult trial enrollment ongoing; initial data readout on track for H2 2025.

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