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The FDA has agreed to a single pediatric approval study in which the anamayicin in combination with sitearabin will be evaluated as the second row therapy in pediatric R/R AML patients.

Moleculin has intended to submit a revised study plan by incorporating the recommendations of the FDA in this quarter. The company is expected to start pediatric studies in the second half of 2027.

“Getting this written response from the FDA is an important step in the development of anamicin for the use of pediatrics and provides us a useful insight as we continue to prepare for the launch of the planned pediatric test planned for the second half of 2027,” said the chairman and CEO of Walter Claums.

A phase 3 study is underway in adults with R/R AML, a phase 3 study of the Miracles dubbed, in which the initial data is expected in the second half of the readout 2025.

The idea and opinion expressed here are the idea and opinion of the author and not necessarily Nasdac, Inc.