Cellectar Biosciences, Inc.

Cellectar Biosciences Reports Case Study Highlighting Complete Response Lasting More Than Eight Years in Heavily Pretreated DLBCL Patient Treated with Iopofosine I 131

Cellectar Biosciences reported a case study of a heavily pretreated double-hit DLBCL patient who achieved a complete response lasting more than eight years after a single 57.5 mCi dose of iopofosine I 131. The 53-year-old patient, after four prior therapy lines and a stem cell transplant, showed no disease progression and required no additional anticancer therapy as of May 2026, with expected hematologic toxicities that all resolved. Management said the findings validate the PDC platform alongside Phase 2b CLOVER WaM data, with the confirmatory Phase 3 in Waldenström macroglobulinemia expected to begin dosing in Q1 2027 and an accelerated approval submission to the FDA targeted for the first half of 2027. The case is a single-patient experience; findings will be submitted for journal publication or presentation at a medical meeting.

•5d ago

Cellectar Biosciences Presents Compelling Efficacy Data from Phase 2b CLOVER WaM Subset Analysis of Iopofosine I 131 in Patients Relapsed/Refractory to BTK Inhibitor Therapy at the International Workshop for Waldenström Macroglobulinemia

Cellectar presented Phase 2b CLOVER WaM subset data at the IWWM showing iopofosine I 131 achieved an 87.5% overall response rate, 79.2% major response rate, and 100% clinical benefit rate in 24 WM patients treated immediately after BTK inhibitor therapy. Median duration of response was 16.0 months with 19.1-month treatment-free survival, and treatment-emergent adverse events occurred in under 10% of patients despite 75% being BTKi refractory. The company is initiating a Phase 3 confirmatory trial with PFS as the primary endpoint, with first patient dosing expected in 1Q27 and an NDA for accelerated approval planned for submission in 1H27.

•17d ago

Cellectar Biosciences to Present Compelling Efficacy Data from Phase 2 CLOVER WaM Subset Analysis of Iopofosine I 131 in Patients Refractory/Resistant to BTK Inhibitor Therapy at International Workshop for Waldenström Macroglobulinemia

Cellectar Biosciences will present Phase 2 CLOVER-WaM subset data at the International Workshop for Waldenström Macroglobulinemia (Oct 14-16, Palm Springs) showing iopofosine I 131 achieved a 79.2% major response rate and 87.5% overall response rate in WM patients refractory/resistant to BTK inhibitor therapy. Duration of response exceeded 16 months in patients treated immediately post-BTKi after at least two prior lines of treatment — a heavily pretreated population with significant unmet need. Management reaffirmed plans to dose the confirmatory Phase 3 trial in early 2027 and file for U.S. accelerated approval in 1H27, with a potential approval by end of 2027 given Breakthrough Therapy Designation.

•1mo ago

Cellectar Biosciences Reports Second Quarter 2026 Financial Results and Provides Corporate Updates

Cellectar Biosciences reported Q2 2026 financial results with cash balance increasing to $34.0 million, extending the runway into Q2 2027 following a $35 million upfront raise in May. The net loss for the quarter was $6.9 million, or $0.57 per share, as R&D expenses increased to $4.6 million to support advancing clinical programs. Operationally, the company initiated site activation for the confirmatory Phase 3 trial of iopofosine I 131 in Waldenström macroglobulinemia, with an NDA submission planned for mid-2027. Recent ASCO data for the drug demonstrated an 87.5% overall response rate and 100% clinical benefit rate in a subset of patients. The company also dosed the first patients in a Phase 1b trial of CLR 125 for triple-negative breast cancer and published Phase 1 data in the journal Cancers. Management will host a webinar on its PDC platform on August 18.

•2mo ago

Cellectar Biosciences Announces Publication of Phase 1 Study of Iopofosine I 131 in Peer-Reviewed Journal Cancers

Cellectar Biosciences announced the publication of Phase 1 results for iopofosine I 131 in relapsed/refractory multiple myeloma within the peer-reviewed journal Cancers. The study of 31 heavily pretreated patients reported a manageable safety profile with primarily reversible hematologic toxicities and an overall response rate of 15.4%, with 84.6% of evaluable patients achieving stable disease or better. Based on the data, authors recommended a Phase 2 fractionated regimen of 15 mCi/m² on days 1 and 7, with management highlighting the drug's potential to address a broad range of B-cell malignancies.

•3mo ago

Cellectar Biosciences Reports Positive 12-Month Follow-Up Data from Phase 2b CLOVER WaM Study Demonstrating Durable Responses and Efficacy of Iopofosine I 131 in r/r Waldenström Macroglobulinemia

Cellectar Biosciences reported positive 12-month follow-up data from the Phase 2b CLOVER WaM study of iopofosine I 131 in relapsed or refractory Waldenström macroglobulinemia. The dataset, which meets FDA requests for accelerated approval, demonstrated an 83.6% overall response rate and a median duration of response of 17.8 months. Iopofosine showed strong efficacy in heavily pretreated BTKi-exposed and refractory patients, achieving a major response rate of approximately 64% with a median duration of response of 18.2 months. The safety profile was manageable with no significant bleeding events and low infection rates. The company plans to initiate a confirmatory randomized study in the fourth quarter of 2026 and will present full results at the upcoming ASCO Annual Meeting. This data supports the potential regulatory submission for accelerated approval in the U.S. and Europe.

•5mo ago

Cellectar Biosciences Announces Oversubscribed Financing Up to $140 Million

Cellectar Biosciences announced an oversubscribed financing of up to $140 million, led by Nantahala Capital, to fund the confirmatory study and NDA filing for Iopofosine I 131 in Waldenström Macroglobulinemia. The transaction consists of approximately $35 million in upfront proceeds and $105 million in milestone-based securities, with participation from institutional investors including Balyasny Asset Management and Janus Henderson Investors. Andrew Gu of Nantahala Capital will join the company's Board of Directors upon closing, marking a significant addition to corporate governance alongside the capital raise.

•5mo ago