Moleculin Gets Positive FDA Feedback On Pediatric Study Plan For Annamycin In Children With R/R AML

(RTTNews) - Moleculin Biotech, Inc. (MBRX) Wednesday said it has received positive feedback from U.S. Food and Drug Administration (FDA) regarding the company's initial pediatric study plan for Annamycin in children with relapsed/refractory acute myeloid leukemia (R/R AML), submitted earlier.

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 R/R AML patients.

Moleculin intends to submit a revised study plan incorporating FDA's recommendations later this quarter. The company expects to initiate the pediatric study in the second half of 2027.

"Receiving this written feedback from FDA is a crucial step in the development of Annamycin for pediatric use and provides us with helpful insight as we continue to prepare for the launch of a pediatric trial, planned for the second half of 2027," said Walter Klemp, Chairman and CEO of Moleculin.

A Phase 3 study of Annamycin plus Cytarabine dubbed MIRACLE in adults with R/R AML is underway, with initial data readout expected in the second half of 2025.