iopofosine I 131

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Cellectar Biosciences and U.S.-based Nusano Enter Into Multi-Isotope Supply Agreement
Globenewswire· 2025-06-26 12:05
Core Insights - Cellectar Biosciences has signed a multi-year supply agreement with Nusano for iodine-125 and actinium-225, essential for its clinical studies and future commercial needs [1][2] - This partnership is crucial for advancing Cellectar's targeted radiotherapy programs, including CLR-125 for triple-negative breast cancer and CLR-225 for pancreatic cancer [2][5] - Nusano's next-generation production facility in Utah will produce these isotopes, addressing supply chain challenges and enabling innovation in cancer treatment [2][3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [4] - The company's product pipeline includes iopofosine I-131, CLR 121225, and CLR 121125, targeting various solid tumors with significant unmet needs [5][6] - Cellectar has received multiple designations from the FDA for its products, including Breakthrough Therapy Designation and Orphan Drug Designation [6] Industry Context - Nusano aims to stabilize the supply of medical radioisotopes, which are critically undersupplied in the market, and to support innovation across multiple industries [3] - The partnership between Cellectar and Nusano highlights the growing importance of reliable access to high-quality radioisotopes for advancing cancer therapies [2][3]
Cellectar Biosciences Submits Phase 1b Clinical Trial Protocol to US Food and Drug Administration for CLR 125 to Treat Triple-Negative Breast Cancer (TNBC)
Globenewswire· 2025-06-24 12:30
Good Tolerability and Robust Tumor Uptake were Observed in TNBC Animal Models Auger Emitters Offer the Potential Benefit of Enhanced Cytotoxicity, Safety and Ease-of-Use FLORHAM PARK, N.J., June 24, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (Nasdaq: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced that the company has submitted a protocol with the U.S. Food and Drug Administration (FDA) for a Phas ...
Cellectar Biosciences Announces One-for-Thirty Reverse Stock Split
GlobeNewswire News Room· 2025-06-18 20:30
FLORHAM PARK, N.J., June 18, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (Nasdaq: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced a one-for-thirty reverse stock split (the “Reverse Stock Split”) of the company’s common stock, par value $0.00001, which will become effective at 12:01 a.m. Eastern Time on Tuesday, June 24, 2025. The company’s common stock will continue to trade under its current tradi ...
Cellectar Biosciences Provides Update on CLOVER-2 Phase 1 Clinical Trial of Iopofosine I 131 in Pediatric Patients with Relapsed/Refractory High-Grade Glioma
Globenewswire· 2025-06-11 12:05
In Patients Receiving a Minimum of 55 mCi an Average 5.4 Months of PFS was Observed: Twice the Reported 2.25 MedianFLORHAM PARK, N.J., June 11, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced initial results as of June 10, 2025, from the CLOVER-2 Phase 1 clinical trial evaluating iopofosine I 131 in relapsed/refractory pediatric high-grade glioma ...
Cellectar Biosciences Enters into Common Stock Agreements to Raise $2.5 Million Priced at Market Under Nasdaq Rules
Globenewswire· 2025-06-05 13:00
FLORHAM PARK, N.J., June 05, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced the entry into definitive agreements to raise $2.5 million from the sale of shares of the company’s common stock priced at-market for Nasdaq purposes. The closing of the offering is expected to occur on or about June 6, 2025, subject to satisfaction of customary closing ...
Cellectar Granted U.S. FDA Breakthrough Therapy Designation for Iopofosine I 131 in Waldenstrom Macroglobulinemia (WM)
Globenewswire· 2025-06-04 12:05
Designation Supported by CLOVER WaM Phase 2 Study DataWhich Reported an 83.6% Overall Response Rate (ORR) Seeking Guidance from EMA to Determine if CLOVER WaM Phase 2 Data Meets Criteria to Apply for Fast-Track, Conditional Marketing Authorization, Answer Expected Late July FLORHAM PARK, N.J., June 04, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announ ...
Cellectar Biosciences Reports First Quarter 2025 Financial Results and Provides a Corporate Update
Globenewswire· 2025-05-13 11:05
Core Insights - Cellectar Biosciences is seeking conditional marketing approval from the European Medicines Agency (EMA) for its product Iopofosine I 131 based on the promising results from the CLOVER WaM Phase 2 study, which showed a major response rate of 59.0% for BTKi-treated patients [1][2] - The company has a pipeline of radiotherapeutic candidates, including alpha- and Auger-emitting radioconjugates, and is exploring various funding pathways to advance its assets [2][5] Corporate Update - Cellectar plans to present the Phase 2 CLOVER WaM clinical trial data to the EMA in Q2 2025 and expects a response regarding the regulatory pathway by the end of Q3 2025 [2] - The company is evaluating strategic alternatives, including mergers, acquisitions, and partnerships, with Oppenheimer & Co. Inc. serving as the exclusive financial advisor [5] Financial Highlights - As of March 31, 2025, Cellectar had cash and cash equivalents of $13.9 million, down from $23.3 million as of December 31, 2024 [5][14] - Research and Development (R&D) expenses for Q1 2025 were approximately $3.4 million, a decrease from $7.1 million in Q1 2024, primarily due to reduced patient follow-up activities [5][15] - General and Administrative (G&A) expenses for Q1 2025 were approximately $3.0 million, down from $4.9 million in the same period of 2024 [5][15] - The net loss for Q1 2025 was $6.6 million, or $0.14 per share, compared to a net loss of $26.6 million, or $0.91 per share, in Q1 2024 [5][16] Product Pipeline - The company's lead assets include Iopofosine I 131, CLR 121225 (an actinium-225 based program for solid tumors), and CLR 121125 (an iodine-125 Auger-emitting program) [8][9] - Iopofosine I 131 has received multiple designations from the FDA, including six Orphan Drug and two Fast Track Designations for various cancer indications [9]
Cellectar Announces Plan to Explore Strategic Alternatives
Globenewswire· 2025-04-30 12:05
Core Viewpoint - Cellectar Biosciences, Inc. is exploring a full range of strategic alternatives to enhance stockholder value, including potential mergers, acquisitions, partnerships, and licensing arrangements [1][2]. Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [4]. Product Pipeline - The company's lead product, iopofosine I 131, is designed for targeted delivery of iodine-131 and has been studied in Phase 2b trials for multiple myeloma and CNS lymphoma [5][6]. - Other significant assets include CLR 225, targeting solid tumors like pancreatic cancer, and CLR 125, aimed at triple negative breast, lung, and colorectal cancers [5]. Strategic Evaluation Process - The company has engaged Oppenheimer & Co. Inc. as its exclusive financial advisor to assist in evaluating strategic alternatives, with no set timetable for completion [1][3]. - There are no guarantees that any transaction will result from this evaluation process [3].