Aug. 9 at 9:45 PM
$CLRB
The likelihood of Cellectar Biosciences securing FDA Accelerated Approval for its lead radiopharmaceutical, iopofosine I-131, in the second half of 2027 is high (estimated at 75%–85%).The Total Addressable Market (TAM) for the drug across its initial target indications is approximately
$2.1 billion annually, heavily driven by its lead indication in relapsed/refractory Waldenström’s Macroglobulinemia (r/r WM).
High Probability Regulatory CatalystsConfirmed Pathway: The FDA has explicitly confirmed an accelerated approval pathway using data from the Phase 2b CLOVER-WaM trial. The trial met its primary endpoints, boasting an 83.6% Overall Response Rate (ORR) and a 61.8% Major Response Rate (MRR).
