Bernstein reveals top biotech picks that could change the market in 2025

In the United States on January 12, 2025, Cellectar Biosciences, a late-stage clinical biopharmaceutical company focused on cancer treatments, announced its plans to present its strategic initiatives for 2025. This announcement is set to take place at the Biotech Showcase, which runs from January 13-15, during the 43rd Annual JP Morgan Healthcare Conference in San Francisco. James Caruso, the president and CEO of Cellectar, is scheduled to provide a corporate update, which includes advancements in their key drug, Iopofosine I 131, used for treating relapsed/refractory Waldenstrom’s Macroglobulinemia. The recent oral presentation at the American Society of Hematology (ASH) 2024 conference revealed that Iopofosine I 131 achieved an impressive 83.6% overall response rate (ORR) and surpassed both primary and secondary efficacy endpoints in their Phase 2 CLOVER-WaM study. This positive data has provided Cellectar with a strong basis to pursue regulatory pathways, including a conditional market approval from the U.S. Food and Drug Administration, which they believe is feasible based on ongoing communications with the agency. Cellectar's strategy for 2025 also includes plans for future studies and drug applications. The company intends to conduct a confirmatory randomized controlled study with 40-60 patients per arm, aiming for full enrollment within 18 months. Moreover, Cellectar's lead radioconjugate PRC, CLR 121225, demonstrates potential in several solid tumor models. The firm is optimistic about new drug applications as it moves forward with these developments. They are also working to enhance their partnership opportunities in the wake of positive clinical results. Additionally, the company’s product pipeline is robust and includes Iopofosine I 131, expected to address significant unmet medical needs in oncology. They are preparing submissions related to the European Medicines Agency for marketing authorization as well. These developments aim to leverage results from clinical studies and comply with agency recommendations to strategize a pathway for global approvals, emphasizing Cellectar's commitment to addressing critical health challenges in cancer treatment.