Actinium (ATNM) Lags PRISM Pharma Index as Stock Falls Over 65%

The PRISM Emerging Pharmaceutical Index company, Actinium Pharmaceuticals, Inc. (ATNM) has traded down over 65% today after announcing that the FDA has their phase 3 trial of leukemia treatment is not enough for a BLA filing. The company will request a meeting with the FDA to further discuss more details on an additional trial and intends to seek a strategic partner for Iomab-B in the US once its meeting with the FDA is complete.

Sandesh Seth , Actinium’s Chairman and CEO, said, “We are disappointed that the positive results from the SIERRA trial are not deemed adequate by the FDA to support a BLA filing despite meeting the primary endpoint with statistical significance and producing positive efficacy and safety outcomes on several measures. SIERRA represented a first of its kind radiotherapeutic trial and demonstrated Actinium’s ability to execute seamlessly across manufacturing, supply chain, clinical development, and operations. We intend to leverage these capabilities as we continue to advance our highly differentiated antibody radiation conjugate pipeline for cell & gene therapy conditioning, hematology therapeutics and solid tumor candidates. We are committed to establishing the best development path forward for Iomab-B in the U.S. and finding a partner, while keeping internal resources and strategic priorities in focus.”