Cellectar Biosciences (CLRB) said Wednesday the US Food and Drug Administration has granted breakthrough therapy designation to its experimental cancer drug, iopofosine I 131, for the treatment of relapsed or refractory Waldenstrom macroglobulinemia, a rare and currently incurable form of lymphoma.
The company said the designation was based on results from a phase 2 trial, where the drug achieved an 83.6% overall response rate and a 58.2% major response rate, significantly exceeding its 20% target.
Cellectar said it also submitted a data package to the European Medicines Agency to determine whether it can pursue conditional marketing authorization in the EU, adding that a recommendation on whether to proceed with a full application is expected by late July 2025.
Shares of the company were up more than 43% in Wednesday's premarket activity.
Price: 0.40, Change: +0.12, Percent Change: +43.62
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.