---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-096928"
form_type: "8-K"
ticker: "CLRB"
cik: "0001279704"
company_name: "Cellectar Biosciences, Inc."
filed_at: "2025-10-06T23:59:59+00:00"
generated_at: "2026-05-17T04:33:05.947048+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-25-096928
- form_type: 8-K
- ticker: CLRB
- cik: 0001279704
- company_name: Cellectar Biosciences, Inc.
- filed_at: 2025-10-06T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1279704/000110465925096928/0001104659-25-096928-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1279704/000110465925096928/tm2528016d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-096928
- JSON: https://secwatch.observer/filing/0001104659-25-096928.json
- Plain text: https://secwatch.observer/filing/0001104659-25-096928.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.