Core Insights - Cellectar Biosciences, Inc. has announced a strategic update regarding its clinical development programs for its proprietary phospholipid ether drug conjugate platform targeting cancer [1] - The company is pursuing strategic options for the further development and commercialization of its product candidate, iopofosine I 131, following recent communications with the FDA [1][3] Group 1: Clinical Development and Regulatory Updates - The CLOVER-WaM study was conducted based on earlier FDA communications, indicating that positive results for major response rate (MRR) could support accelerated approval for iopofosine I 131 in treating Waldenstrom's macroglobulinemia (WM) [2] - A Type-C meeting with the FDA indicated that a submission for accelerated approval would need to be based on MRR data from CLOVER-WaM and enrollment in a randomized, controlled confirmatory study focused on progression-free survival (PFS) [3] Group 2: Strategic Focus and Resource Allocation - The company plans to concentrate its resources on targeting solid tumors by advancing its actinium-225-based program CLR 121225 and iodine-125 Auger-emitting program CLR 121125 into clinical trials [4] - Cellectar expects to file Investigational New Drug applications for both CLR-121225 and CLR-121125 in the first half of 2025, initiating Phase 1 clinical studies in solid tumor cancers [5] Group 3: Financial and Operational Adjustments - The company will reduce its headcount by approximately 60%, expected to be completed by the end of the fourth quarter of 2024, to extend its cash runway into the third quarter of 2025 [5] - Following these developments, CLRB stock has seen a significant decline of 73.40%, trading at $0.34 [6]
Cellectar Biosciences Stock Plunges As Cancer-Focused Cancer Firm Pursues Strategic Options