Cellectar Biosciences Inc. Soars on FDA Breakthrough Therapy Designation
In a significant development for Cellectar Biosciences Inc., the company’s stock experienced a remarkable surge following the announcement of a Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its drug candidate, Iopofosine I 131, aimed at treating Waldenstrom Macroglobulinemia (WM). This designation, granted on June 4, 2025, underscores the potential of Iopofosine I 131 to offer substantial improvements over existing therapies for this incurable cancer, which has limited treatment options.
The FDA’s Breakthrough Therapy Designation is reserved for drugs that demonstrate the potential to significantly improve upon existing therapies for serious or life-threatening conditions. This status is expected to expedite the development and review process, providing Cellectar with a more streamlined pathway to bring Iopofosine I 131 to market. The designation follows impressive Phase 2 clinical trial results, where Iopofosine I 131 achieved an overall response rate of 83.6% and a major response rate of 58.2%, both exceeding the initial target of 20%.
Cellectar’s stock, which closed at $0.26 on May 29, 2025, saw a dramatic increase, with reports indicating a peak rise of up to 147% on the day of the announcement. This surge reflects investor confidence in the company’s potential to capitalize on the accelerated approval process and the promising clinical outcomes of its lead drug candidate.
The Breakthrough Therapy Designation is not the only regulatory milestone for Iopofosine I 131. Cellectar has also secured multiple designations from both the FDA and the European Medicines Agency (EMA), further bolstering its prospects for a successful market entry. These regulatory achievements highlight the drug’s potential as a first-in-class treatment for WM, offering hope to patients with limited therapeutic options.
Cellectar Biosciences Inc., headquartered in Middleton, United States, operates within the Health Care sector, focusing on the Biotechnology industry. The company specializes in developing drugs for the treatment and diagnosis of various cancers, serving the medical, pharmaceutical, and healthcare industries. With a market capitalization of approximately $11.48 million as of the latest data, Cellectar’s breakthrough represents a pivotal moment in its journey to commercialize innovative cancer therapies.
The FDA’s endorsement of Iopofosine I 131 not only accelerates its path to market but also enhances Cellectar’s commercial prospects and potential for strategic partnerships. As the company moves forward, the Breakthrough Therapy Designation positions it as a key player in the biotechnology sector, with the potential to significantly impact the treatment landscape for Waldenstrom Macroglobulinemia and beyond.
For more information on Cellectar Biosciences Inc. and its offerings, interested parties can visit the company’s website at www.cellectar.com . The company continues to trade on the Nasdaq stock exchange, where it remains a focal point for investors seeking opportunities in the biotechnology and healthcare sectors.