Actinium issued a press release on August 5, 2024, “announc[ing] a regulatory update on the Company’s planned Biologics License Application (‘BLA’) filing for Iomab-B in patients with active relapsed or refractory acute myeloid leukemia (‘r/r AML’).” The press release stated, in relevant part, that the U.S. Food And Drug Administration had “determined that the Phase 3 SIERRA trial is not adequate to support a BLA filing for Iomab-B despite its statistically significant primary endpoint[.]”

Following this news, Actinium’s stock price fell over 59% the same day.