EMA confirms iopofosine I 131 eligible for Conditional Marketing Authorization in post-BTKi WM

Cellectar Biosciences, Inc.

SAWP advised filing a CMA for iopofosine I 131 in post-BTKi refractory WM could be acceptable.
CMA submission planned for early 2026; potential commercial launch in up to 30 EMA countries by 2027.
CLOVER WaM Phase 2 study showed ORR 83.6%, MRR 58.2%; >70% patients were post-BTKi.
Company also pursuing US NDA under accelerated approval, contingent on funding for confirmatory study.
Estimated 35,000-45,000 WM patients in Europe with significant unmet need.

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