Welcome to our dedicated page for Cellectar Biosciences news (Ticker: CLRB), a resource for investors and traders seeking the latest updates and insights on Cellectar Biosciences stock.
Cellectar Biosciences Inc. (NASDAQ: CLRB) is a clinical-stage biopharmaceutical company pioneering targeted cancer therapies through its proprietary Phospholipid Drug Conjugate™ platform. This centralized news resource provides investors and healthcare professionals with essential updates on clinical developments, regulatory milestones, and strategic partnerships.
Access real-time information about CLRB’s radiopharmaceutical pipeline, including lead candidate iopofosine I 131 for hematologic malignancies and emerging programs targeting solid tumors. Our news collection covers critical updates ranging from trial results to manufacturing advancements, all curated to support informed decision-making.
Key content areas include clinical trial progress, FDA designations, scientific presentations, and corporate collaborations. The platform serves as a reliable source for tracking the company’s mission to improve cancer treatment precision through its novel drug delivery technology.
Bookmark this page for continuous access to verified updates about Cellectar’s innovative oncology programs. Check regularly for new developments in targeted radiopharmaceuticals and PDC platform applications across therapeutic areas.
Cellectar (NASDAQ: CLRB) reported Q3 2025 results and a corporate update on Nov 13, 2025. Key clinical and regulatory progress includes SAWP/EMA advice confirming eligibility to seek a Conditional Marketing Authorization (CMA) for iopofosine I-131 in post-BTKi refractory Waldenstrom macroglobulinemia with a planned CMA submission in 2026, ongoing plans for an NDA to FDA for accelerated approval (subject to funding), and receipt of rare pediatric drug designation for inoperable relapsed/refractory pediatric high-grade glioma. The company initiated a Phase 1b CLR 125 study in TNBC and completed IND-enabling work for CLR 225 with an Ac-225 supply agreement. Financials: $12.6M cash at 9/30/25, net loss $4.4M for Q3, and recent fundraising of approximately $12.7M.
Cellectar Biosciences (NASDAQ: CLRB) will report third quarter financial results for the period ended September 30, 2025 and provide a corporate update on Thursday, November 13, 2025 at 8:30 a.m. Eastern Time.
The company will host a conference call and webcast for investors and analysts; a replay of the corporate presentation will be available in the Events section of the company’s Investor Relations website.
Cellectar Biosciences (NASDAQ: CLRB) announced on October 27, 2025 that the U.S. FDA granted Rare Pediatric Disease Designation for iopofosine I 131 in inoperable relapsed or refractory pediatric high-grade glioma (r/r pHGG).
Interim CLOVER-2 Phase 1b data presented at AACR showed that patients receiving a minimum total administered dose of 55 mCi (n=6) experienced average PFS 5.4 months and OS 8.6 months (ongoing). Three patients receiving ≥4 infusions showed average PFS 8.1 months and OS 11.5 months (ongoing), with two objective responses. No treatment-related deaths were reported; safety events were primarily hematologic and manageable.
Cellectar Biosciences (NASDAQ: CLRB) presented preclinical data for CLR 225 at the AACR Special Conference on Pancreatic Cancer Research (Sept 28–Oct 1, 2025). The poster reported that CLR 225, an actinium-based alpha-emitter, completed IND-enabling studies and showed meaningful inhibition of tumor growth or reduced tumor volume across three pancreatic ductal adenocarcinoma xenograft models (PANC-1, MIA PaCa-2, BxPC-3).
The program demonstrated predictable, linear biodistribution, was well tolerated in dosing studies with no body-weight loss, and showed no toxicities in GLP toxicity studies; the company retains the option to advance to a Phase 1 first-in-human study.
Cellectar Biosciences (NASDAQ:CLRB) announced agreements with institutional investors resulting in the immediate exercise of existing warrants and gross proceeds of approximately $5.8 million prior to placement agent fees and offering expenses. An aggregate of 1,048,094 existing warrants were exercised.
In the transactions, holders paid $5.25 per existing warrant and $0.125 per new warrant, receiving 1,048,094 Series I and 1,048,094 Series II new unregistered warrants exercisable at $6.00. Series I term: 5 years; Series II term: 18 months. Net proceeds will fund working capital, the Phase 1b CLR 121125 trial in triple-negative breast cancer, and preparation of a CMA filing with the European Medicines Agency. The company will file a registration statement covering resale of shares issuable upon exercise.
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.
FAQ
What is the current stock price of Cellectar Biosciences (CLRB)?
What is the market cap of Cellectar Biosciences (CLRB)?
