secwatch.observer — SEC 8-K summary
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Issuer:     Cellectar Biosciences, Inc. (CLRB)
CIK:        0001279704
Form:       8-K
Filed at:   2025-10-06T23:59:59+00:00
Accession:  0001104659-25-096928
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1279704/000110465925096928/0001104659-25-096928-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1279704/000110465925096928/tm2528016d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-096928

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer