What's Behind Cellectar Biosciences' Stock Surge? FDA Update Explained

Cellectar Biosciences, Inc. CLRB stock is trading higher on Wednesday.

As per data from Benzinga Pro, session volume stands at 361.96 million versus an average volume of 968.03k.

What Happened: The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation on Wednesday for the company’s iopofosine I 131, a potential first-in-class, novel cancer-targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy, for relapsed/refractory Waldenstrom macroglobulinemia (r/r WM).

Also Read: Cellectar Biosciences Stock Plunges As Cancer-Focused Cancer Firm Pursues Strategic Options

Why It Matters: WM is the dominant subtype of lymphoplasmacytic lymphoma.

Data from the Phase 2 CLOVER WaM study, including the overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2%, which exceeded the agreed-upon primary endpoint of a 20% MRR, were presented during the 66th Annual American Society of Hematology Conference in December 2024.

As previously announced, the FDA also granted iopofosine I 131 Fast Track Designation and Orphan Drug Designation.

The European Medicines Agency (EMA) granted Orphan Drug Designation to iopofosine I 131 for r/r WM and PRIME Designation for WM.

What’s Next: Separately, the company has provided the EMA with a data package that includes extensive supportive preclinical, regulatory, and manufacturing data and safety and efficacy data from the CLOVER WaM Phase 2b clinical trial.

The EMA will review the package to determine whether there is enough clinical evidence to address the required criteria for Cellectar to apply for a fast-track, conditional marketing authorization approval.

In late July 2025, the company expects a recommendation from the EMA on whether Cellectar should file a Medical Authorization Application.

Price Action: CLRB stock is trading higher by 57.9% to $0.43 at last check Wednesday.

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