secwatch.observer — SEC 8-K summary
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Issuer:     Cellectar Biosciences, Inc. (CLRB)
CIK:        0001279704
Form:       8-K
Filed at:   2025-01-14T23:59:59+00:00
Accession:  0001104659-25-003208
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Cellectar reports iopofosine 83.6% ORR in WM; plans confirmatory study for accelerated approval
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- Iopofosine I 131 achieved 83.6% ORR and 58.2% MRR in Phase 2 CLOVER-WaM for Waldenstrom's Macroglobulinemia; primary endpoint of 20% MRR exceeded.
- Company expects confirmatory randomized study (40-60 patients/arm) with FDA alignment in H1 2025; cash runway through Q4 2025.
- Advancing alpha-emitting PRC CLR 121225 into Phase 1/2a solid tumor studies; IND filing expected Q1 2025.
- Auger-emitting PRC CLR 121125 IND cleared; Phase 1b/2a dose finding study in triple-negative breast cancer planned.
- Company pursuing partnerships for iopofosine; presentation at Biotech Showcase on Jan 14, 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1279704/000110465925003208/0001104659-25-003208-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1279704/000110465925003208/tm253236d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-003208

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