Regulatory Strategy Shift for Iopofosine I-131:
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Biosciences announced a shift in regulatory strategy for iopofosine I-131, planning to pursue an accelerated approval pathway for Waldenstrom's Macroglobulinemia treatment.
- The decision was based on a subset analysis demonstrating iopofosine's potential efficacy in post-BTKi failure patients and having a minimum of 12 months of follow-up data.
Next-Generation Radiopharmaceutical Pipeline Progress:
- Cellectar is advancing CLR 125 and CLR 225 as promising candidates for Phase I trials in triple-negative breast cancer and pancreatic cancer, respectively.
- The progress is supported by strong preclinical results and the submission of Phase I protocols to the FDA.
Financial Position and Fundraising:
- Cellectar reported an ending cash position of
$11 million, including
$2.3 million raised from a June financing.
- The company has raised nearly
$10 million in recent financings to support clinical programs and regulatory milestones.
Operational Strengthening:
- Cellectar secured a long-term isotope supply agreement to support its clinical programs.
- The agreement enhances the company's operational foundation and ensures a stable supply of necessary isotopes for its therapies.
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