Materiality pending
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FDA found ATNM's SIERRA trial inadequate for BLA filing. Actinium must conduct a new head-to-head study as advised by the FDA. The SIERRA trial showed significant primary endpoint but failed overall survival. Control group crossover affected survival analysis, prompting the FDA's decision. ATNM stock fell 74% to $1.59 following the update.
- FDA found ATNM's SIERRA trial inadequate for BLA filing.
- Actinium must conduct a new head-to-head study as advised by the FDA.
- The SIERRA trial showed significant primary endpoint but failed overall survival.
- Control group crossover affected survival analysis, prompting the FDA's decision.
- ATNM stock fell 74% to $1.59 following the update.
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