Cellectar reports Q3 2026 results, confirms 2027 timelines for iopofosine I 131
The company says it is still positioned to begin dosing in its Phase 3 WM trial in early 2027 and to file for accelerated approval with the FDA in the first half of that year.
Cellectar Biosciences reported financial results for the quarter ended September 30, 2026, and gave a corporate update on November 10, 2026. The company said it remains on schedule to begin treating the first patient in its Phase 3 confirmatory trial during the first quarter of 2027 and to file a New Drug Application with the FDA in the first half of 2027 seeking accelerated approval.1
That confirmatory study, aimed at Waldenström macroglobulinemia patients who have already had BTK inhibitor therapy, will be a randomized, comparator-controlled trial enrolling 100 patients per arm in the post-first-line, post-BTKi setting, with progression-free survival as the primary endpoint.1 Cellectar also moved forward on trial preparations, including activating its first clinical sites.1
Separately, the company began preparing a Phase 1b dosimetry trial of iopofosine I 131 across all WM treatment lines, a study requested by the FDA.1 That trial is expected to generate clinical activity data from 20 to 30 newly diagnosed and relapsed patients, which could support use in earlier lines of therapy.1
At the International Workshop for Waldenström Macroglobulinemia, Cellectar presented new subset data from patients treated with iopofosine I 131 right after BTKi therapy. Among 24 evaluable patients, overall response rate was 87.5%, major response rate was 79.2%, median duration of response was 16.0 months, treatment-free survival was 19.1 months, and clinical benefit rate was 100%, with treatment-emergent adverse events in fewer than 10% of patients and cytopenias the only Grade 3 or higher events.1 The company also plans to present three posters at ASH 2026 with updated 12-month CLOVER-WaM follow-up data, including the first detailed presentation of its Phase 3 trial design.1
On the CLR 125 program in triple-negative breast cancer, Cellectar said its dose-finding Phase 1b trial continues to enroll, with initial dosimetry and safety data expected in the fourth quarter of 2026.1
On finances, Cellectar reported cash and cash equivalents of $24.6 million as of September 30, 2026, up from $13.2 million at the end of 2025, reflecting about $31.7 million in net proceeds from a May 2026 offering.1 The company said this cash balance is expected to fund operations into the second quarter of 2027.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.