Actinium Pharmaceuticals (ATNM) issued a regulatory update on the planned Biologics License Application filing for Iomab-B in patients with active relapsed or refractory acute myeloid leukemia. The company has concluded both clinical and Chemistry, Manufacturing and Controls interactions with the FDA regarding the BLA pathway for Iomab-B. The FDA has now determined that the analyses from the SIERRA trial do not adequately support a BLA filing for Iomab-B. The FDA has now determined that demonstrating an overall survival benefit in a randomized head-to-head trial is required for a BLA filing.
The FDA has advised Actinium to conduct a study to evaluate allogeneic bone marrow transplant using Iomab-B plus a reduced intensity conditioning regimen of fludarabine and total body irradiation versus allogeneic BMT using reduced intensity conditioning comprised of cyclophosphamide plus Flu/TBI, a difference from the SIERRA trial. Also, the proposed additional trial will not allow crossover, which was allowed in SIERRA.
Shares of Actinium Pharmaceuticals are down 64% in pre-market trade on Monday.
For More Such Health News, visit rttnews.com.
For comments and feedback contact: editorial@rttnews.com
Business News
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.