other material
confidence high
sentiment negative
materiality 0.75
Cellectar delays WM pivotal trial top-line data to H2 2023; pediatric glioma trial to start Q3
Cellectar Biosciences, Inc.
- Top-line data from WM CLOVER-WaM trial delayed to H2 2023; 2024 product launch still targeted.
- All 49 sites now active; enrollment accelerated after initial delays from site contracting and regulatory responses.
- Plans to initiate Phase 1b study in pediatric high-grade gliomas in Q3 2023, supported by $2M NCI grant.
- Iopofosine I 131 showed 100% ORR, 83.3% major response rate in Phase 2a WM study (6 patients).
- Fast Track Designation allows 6-month FDA review; platform expands to alpha-emitter, siRNA, and peptide payloads.