FDA Determines That Actinium Pharmaceuticals' Phase 3 Sierra Trial Is Not Adequate To Support A BLA Filing For Iomab-B For Relapsed Or Refractory Acute Myeloid Leukemia, Despite Its Statistically Significant Primary Endpoint
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The FDA has determined that Actinium Pharmaceuticals' Phase 3 Sierra Trial is not adequate to support a BLA filing for Iomab-B for relapsed or refractory acute myeloid leukemia, despite achieving its primary endpoint. Actinium will need to conduct an additional head-to-head randomized clinical trial to demonstrate overall survival benefit. The company plans to request a meeting with the FDA to discuss the specifics and will seek a strategic partner for Iomab-B in the U.S. Actinium will also focus on developing Actimab-A, Iomab-ACT, and preclinical programs.
August 05, 2024 | 11:12 am
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The FDA has determined that Actinium Pharmaceuticals' Phase 3 Sierra Trial is not adequate to support a BLA filing for Iomab-B, requiring an additional trial. Actinium will seek a strategic partner and focus on other development programs.
The FDA's decision not to support a BLA filing for Iomab-B is a significant setback for Actinium Pharmaceuticals, likely leading to a negative short-term impact on the stock price. The need for an additional trial delays potential market entry and increases costs. However, the company's plan to seek a strategic partner and focus on other programs may mitigate some of the negative impact.
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