Cellectar's Iopofosine I-131 Granted FDA Breakthrough Therapy Designation For Relapsed/Refractory Waldenstrom Macroglobulinemia Based On CLOVER WaM Phase 2 Study Showing 83.6% Response Rate; EMA Guidance On Conditional Approval Pathway Expected By Late July

Designation Supported by CLOVER WaM Phase 2 Study Data

Which Reported an 83.6% Overall Response Rate (ORR)

Seeking Guidance from EMA to Determine if CLOVER WaM Phase 2 Data Meets Criteria to Apply for Fast-Track, Conditional Marketing Authorization, Answer Expected Late July

FLORHAM PARK, N.J., June 04, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ:CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for iopofosine I 131, a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy, for the treatment of relapsed/refractory Waldenstrom macroglobulinemia (r/r WM).

WM is the dominant subtype of lymphoplasmacytic lymphoma and remains incurable with available therapies according to the International Waldenstrom's Macroglobulinemia Foundation. Approved WM treatment options are limited, underscoring the need for new therapies with novel mechanisms of action.