According to the Complaint, Actinium Pharmaceuticals, Inc. is a late-stage biopharmaceutical company that is engaged in developing targeted radiotherapies, such as Iomab-B, to improve survival for people who have failed existing oncology therapies. This lawsuit was filed against Actinium and four individual Defendants.

Iomab-B is an induction-and-conditioning agent used before bone marrow transplants and has the potential to treat elderly relapsed or refractory acute myeloid leukemia. Actinium evaluated Iomab-B in the pivotal Phase 3 Sierra trial.

The Complaint alleges that, during the Class Period, Defendants made misleading statements and omissions regarding the Company’s business, financial condition, and prospects. Specifically, the Complaint alleges Defendants failed to disclose that: (1) the Company’s data from the Sierra Trial was unlikely to satisfy the FDA’s guidelines for the acceptance and approval of Iomab-B BLA; (2) the additional analyses, including long-term follow-ups that purportedly demonstrated a trend towards improved Overall Survival that the Company provided to the FDA in an attempt to mitigate Sierra’s poor OS data were unlikely to satisfy the FDA’s guidelines for the acceptance and approval of Iomab-B BLA; (3) as a result, the FDA would likely refuse to review the Iomab-B BLA or, if it did consider that BLA, that the application in its current form was unlikely to be approved; and (4), as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.