Roth Capital Remains Positive on Actinium Pharma (ATNM) as Iomab-B Gains Orphan Designation in Europe

Roth Capital affirms Actinium Pharmaceuticals (NYSE: ATNM) with a Buy rating and $5 price target after the company announced that the Company’s lead asset, Iomab-B, has been granted orphan designation in the European Union (EU) by the European Medicines Agency (EMA). Iomab-B is intended to be used, upon approval, in preparing patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are over the age of 55 for a bone marrow transplant (BMT).

Roth commented today, With U.S. and E.U. orphan designation in hand we believe that there will be greater regulatory interactions and attention given that will help guide Iomab-B studies and keep them on track. The lead focus for the company is Iomab-B in its ongoing Phase III SIERRA study in BMT conditioning, which should read out in 2H18. Enrollment of 150 patients is expected to be completed by the end of 2017. The amount of time required for the treatment compared to current conditioning regimens as well as the overall cost should be significantly reduced, if approved. Additionally, the SME status granted by the E.U. is somewhat analogous to Breakthrough Therapy designation and allows for enhanced regulatory support as well.

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