08:12 AM EDT, 08/05/2024 (MT Newswires) -- Actinium Pharmaceuticals ( ATNM ) shares fell by more than 69% in premarket trading Monday after the company said that the Food and Drug Administration has determined that a phase 3 study of Iomab-B to treat refractory acute myeloid leukemia was not adequate to support a biologics license application.

Actinium said the FDA has now determined that demonstrating an overall survival benefit in a randomized head-to-head trial is required for a BLA filing.

"While this is not the outcome we expected, we will work with the FDA to further discuss specifics of the proposed randomized head-to-head clinical study to determine its strategic feasibility," Chief Medical Officer Avinash Desai said.

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