Actinium’s Radioconjugate Faces Setback as FDA Requests New Study

FDA Request:
The FDA has asked Actinium Pharmaceuticals to conduct a new study for their radioconjugate drug, Iomab-B, which is intended for treating blood cancer.

Drug Composition:
Iomab-B consists of an anti-CD45 antibody conjugated to a radioisotope, designed to target and destroy cancer cells.

Regulatory Impact:
The request for a new study has significantly impacted Actinium Pharmaceuticals, with shares dropping over 72% following the announcement.

Clinical Context:
The study aims to compare the efficacy of Iomab-B combined with a reduced intensity conditioning regimen for allogeneic bone marrow transplantation (BMT).

Industry Reaction:
The setback has prompted Actinium to consider pivoting their strategy, potentially including partnering with other companies to advance their radiotherapy program.