Welcome to our dedicated page for CELLECTAR BIOSC news (Ticker: CLRBZ), a resource for investors and traders seeking the latest updates and insights on CELLECTAR BIOSC stock.
The CLRBZ news page aggregates recent disclosures and media coverage related to Cellectar Biosciences, Inc., a late-stage clinical radiopharmaceutical and biotechnology company listed on NASDAQ under the symbol CLRB. Company communications describe Cellectar as focused on developing phospholipid-based targeted radiotherapeutics and radioconjugates for the treatment of cancer.
News items associated with CLRBZ and Cellectar typically cover updates on the company’s lead asset iopofosine I 131, an iodine-131 Phospholipid Drug Conjugate designed for hematologic and solid tumor cancers, as well as pipeline programs such as CLR 121125 (CLR 125), an iodine-125 Auger-emitting candidate for solid tumors, and CLR 121225 (CLR 225), an actinium-225 based candidate for pancreatic and other cancers. Coverage often includes clinical trial milestones, such as Phase 2b and Phase 1b study updates in Waldenstrom’s macroglobulinemia and pediatric high-grade glioma, and early-stage development plans in triple-negative breast cancer and pancreatic ductal adenocarcinoma.
Investors and observers can use this news feed to follow regulatory developments described by the company, including FDA designations like Breakthrough Therapy, Orphan Drug, Rare Pediatric Disease, and Fast Track, as well as EMA PRIME and orphan designations. Announcements may also highlight guidance from the European Medicines Agency’s Scientific Advice Working Party on potential Conditional Marketing Authorization pathways, along with information on isotope supply agreements and clinical research partnerships.
By reviewing the CLRBZ news page, readers can track how Cellectar characterizes progress across its PDC-based radiotherapeutic pipeline, including scientific presentations, preclinical data releases, financing transactions, and collaboration agreements that the company reports as supporting its oncology programs.
Cellectar Biosciences (NASDAQ: CLRB) announced that the EMA's Scientific Advice Working Party advised iopofosine I 131 meets eligibility requirements for a Conditional Marketing Authorization (CMA) filing in post-BTKi refractory Waldenstrom macroglobulinemia (WM). A CMA submission is expected in early 2026, with potential European approval and commercial launch across the EMA's 30 countries in 2027. Clinical data include a CLOVER WaM Phase 2 overall response rate of 83.6% and major response rate of 58.2%. Iopofosine holds PRIME designation from EMA and multiple FDA designations; the U.S. NDA depends on funding and a confirmatory trial.
Cellectar Biosciences (NASDAQ: CLRB) presented promising interim data from its CLOVER-2 Phase 1b study of iopofosine I 131 at the AACR Special Conference on Pediatric Cancer. The study evaluated the drug's effectiveness in treating relapsed/refractory pediatric high-grade glioma (r/r pHGG).
Key findings include: Patients receiving minimum 55 mCi dose (n=7) showed average PFS of 5.4 months and OS of 8.6 months, significantly exceeding historical medians of 2.25 and 5.6 months respectively. Patients receiving four or more infusions (n=3) demonstrated improved outcomes with 8.1 months PFS and 11.5 months OS. Two notable case studies showed remarkable results, including a patient achieving 50% tumor reduction and survival beyond 18 months.
The treatment was well-tolerated with manageable side effects, primarily hematologic in nature, with no cardiovascular, renal, liver toxicities, or treatment-related deaths reported.
Cellectar Biosciences (NASDAQ:CLRB) has partnered with Evestia Clinical to conduct a Phase 1b clinical trial for CLR 125, an iodine-125 Auger-emitting drug candidate targeting triple-negative breast cancer (TNBC). The trial is set to begin in Q4 2025 at Mayo Clinic, with Dr. Pooja Advani serving as lead investigator.
Evestia Clinical, recently merged with Atlantic Research Group (ARG), will provide comprehensive CRO services, leveraging their experience from over 300 oncology studies. CLR 125 is being developed to treat various solid tumors, including triple negative breast, lung, and colorectal cancers.
Cellectar Biosciences (NASDAQ:CLRB) has entered into a supply agreement with ITM Isotope Technologies Munich SE for Actinium-225 (Ac-225), a crucial isotope for targeted cancer therapies. The agreement will support the clinical development of Cellectar's CLR 121225, a Phase 1-ready compound for treating solid tumors, particularly pancreatic cancer.
The partnership addresses the critical challenge of Ac-225 scarcity in radiopharmaceutical development. ITM, through its joint venture Actineer with Canadian Nuclear Laboratories, will provide Cellectar with medical-grade Ac-225. CLR 121225 has shown promising anti-tumor effects in preclinical studies, utilizing Cellectar's proprietary phospholipid ether (PLE) delivery platform for selective cancer cell targeting.
Cellectar Biosciences (NASDAQ: CLRB) announced its participation in the Oppenheimer 3rd Annual Targeted Radiopharmaceutical Therapies in Oncology Summit on September 11, 2025. The company will discuss several key developments:
The company awaits EMA's decision in late Q3/early Q4 2025 regarding a potential Conditional Marketing Authorization submission for iopofosine I 131 to treat Waldenstrom Macroglobulinemia (WM). Additionally, Cellectar plans to pursue FDA accelerated approval for the same treatment, supported by positive Phase 2b CLOVER WaM trial results.
Cellectar also plans to initiate a Phase 1b trial of CLR 125, their Auger-emitting radiopharmaceutical, for treating triple-negative breast cancer in Q4 2025. The company has secured long-term multi-isotope supply agreements for iodine-125 and actinium-225.
Cellectar Biosciences (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company, announced its participation in multiple medical meetings and industry conferences throughout September 2025. Chief Operating Officer Jarrod Longcor will present at five major events, including the ADC and Novel Conjugates Summit, BioProcess International, and specialized conferences focused on cancer research.
The company will showcase its proprietary Phospholipid Drug Conjugate™ (PDC) platform and discuss its product pipeline, including iopofosine I 131 and other radiopharmaceutical candidates. Notable presentations will cover pediatric brain tumors, pancreatic cancer research, and radiopharmaceutical manufacturing challenges.
Cellectar Biosciences (NASDAQ: CLRB) announced the acceptance of an abstract for poster presentation at the AACR Special Conference on Pancreatic Cancer Research in Boston from September 28-October 1, 2025. The presentation will showcase preclinical data for CLR 121225, the company's novel actinium-based radio conjugate alpha-emitter designed to treat hypoxic pancreatic ductal adenocarcinoma.
Chief Operating Officer Jarrod Longcor will present the poster titled "Targeting Lipid Rafts in Hypoxic Pancreatic Ductal Adenocarcinoma: Preclinical Evaluation of [225Ac]CLR 121225" on September 30. The company reports that preclinical studies have demonstrated promising activity, biodistribution, and uptake across multiple solid tumor animal models, with IND-enabling activities currently in progress.
Cellectar Biosciences (NASDAQ: CLRB) announced that it will present interim data from its CLOVER-2 Phase 1b clinical trial at the upcoming AACR Special Conference on Pediatric Cancer in Boston. The presentation will focus on the study of iopofosine I 131 in treating inoperable relapsed or refractory pediatric high-grade glioma (r/r pHGG).
The company's abstract has been selected for an oral presentation in a plenary session on September 26, 2025, followed by a 55-minute panel discussion. Chief Operating Officer Jarrod Longcor will present the interim findings, which the company reports as encouraging, suggesting potential clinical benefits for patients with limited treatment options.
Cellectar Biosciences (NASDAQ:CLRB) reported Q2 2025 financial results and provided significant updates on its radiopharmaceutical pipeline. The company plans to pursue an FDA NDA submission for iopofosine I 131 to treat Waldenstrom Macroglobulinemia (WM) under accelerated approval, subject to funding and confirmatory trial initiation. The drug received FDA Breakthrough Therapy Designation for WM treatment.
Key financial metrics include cash position of $11.0 million as of June 30, 2025, with an additional $5.8 million raised in July 2025. R&D expenses decreased to $2.4 million from $7.3 million year-over-year, while Q2 net loss was $5.4 million. The company expects current funding to support operations into Q2 2026.
In pediatric high-grade glioma trials, patients receiving minimum dosing showed 5.4 months progression-free survival and 8.6 months overall survival. The company plans to advance CLR 125 into Phase 1 TNBC trials by Q4 2025.
Cellectar Biosciences (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company specializing in cancer treatment drug development, has scheduled its second quarter 2025 financial results announcement and corporate update for August 14, 2025, at 8:30 AM ET.
The company will host a conference call accessible via toll-free number 1-800-717-1738 (Conference ID: 94699) and webcast. A replay of the presentation will be made available in the Events section of Cellectar's Investor Relations website.