FDA requires additional Phase 3 trial for Iomab-B; SIERRA alone not adequate for BLA filing

Actinium Pharmaceuticals, Inc.

SIERRA met primary endpoint (dCR) with p<0.0001, but FDA now demands overall survival benefit in randomized head-to-head trial.
New trial required: Iomab-B plus Flu/TBI vs cyclophosphamide plus Flu/TBI; no crossover allowed (vs 60% crossover in SIERRA).
FDA suggests patient population could include all adult AML; specifics to be discussed in requested meeting.
Actinium will seek a strategic partner for Iomab-B in U.S. after FDA interactions; focus shifts to Actimab-A, Iomab-ACT, preclinical.
Management disappointed but will work with FDA; SIERRA supportive evidence for future BLA filing.

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