Actinium Pharmaceuticals Receives FDA Request For Additional Studies On Leukemia Treatment
Portfolio Pulse from Vandana Singh
Actinium Pharmaceuticals (NYSE:ATNM) received a request from the FDA for additional studies on its leukemia treatment, Iomab-B. The FDA found the Phase 3 SIERRA trial inadequate for a Biologics License Application (BLA) due to issues with the trial design, including high crossover rates. Actinium will need to conduct a new head-to-head study and is seeking a strategic partner for Iomab-B in the U.S. ATNM stock fell 74% to $1.59 following the news.
August 05, 2024 | 3:21 pm
News sentiment analysis
Sort by:
Ascending
NEGATIVE IMPACT
Actinium Pharmaceuticals must conduct additional studies for its leukemia treatment Iomab-B after the FDA found the Phase 3 SIERRA trial inadequate for a BLA. The stock fell 74% to $1.59.
The FDA's request for additional studies significantly delays the approval process for Iomab-B, impacting Actinium's potential revenue and market position. The stock's 74% drop reflects investor concerns over these delays and the additional costs associated with new trials.
CONFIDENCE 100
IMPORTANCE 100
RELEVANCE 100