Cellectar Advances Iopofosine I 131, Initiates TNBC Trial in 4Q25.

Cellectar Biosciences announced plans to pursue an accelerated approval with the US FDA for iopofosine I 131 as a treatment for Waldenstrom macroglobulinemia (WM). The company also highlighted continued progress with the European Medicines Agency regarding a potential conditional marketing authorization submission for the treatment. Additionally, Cellectar intends to advance its Auger-emitting radiopharmaceutical product candidate into a Phase 1b clinical trial for the treatment of triple-negative breast cancer in Q4 2025.

Cellectar Biosciences, Inc. (NASDAQ: CLRB) has announced significant progress in its efforts to secure regulatory approvals and advance its pipeline of targeted radiopharmaceutical therapies. The company plans to pursue an accelerated approval with the U.S. Food and Drug Administration (FDA) for iopofosine I 131 as a treatment for Waldenstrom macroglobulinemia (WM). Additionally, Cellectar is making progress with the European Medicines Agency (EMA) regarding a potential conditional marketing authorization (CMA) submission for the same treatment in the EU. Furthermore, the company intends to advance its Auger-emitting radiopharmaceutical product candidate, CLR 125, into a Phase 1b clinical trial for the treatment of triple-negative breast cancer (TNBC) in the fourth quarter of 2025.

According to Jim Caruso, president and CEO of Cellectar Biosciences, the company recently completed a meeting with the EMA and remains hopeful that the agency will recommend filing for a fast track, conditional marketing authorization approval. The decision from the EMA is expected in the late third quarter or early fourth quarter of 2025. Cellectar is also in active partnering discussions to secure additional capital to support global regulatory requirements and the potential worldwide marketing of iopofosine I 131 .

The company is also advancing its lead auger-emitting asset, CLR 125, into a Phase 1b trial for TNBC in Q4 2025. This trial is part of Cellectar's broader strategy to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop next-generation cancer cell-targeting treatments .

Cellectar Biosciences' product pipeline includes iopofosine I 131, a PDC designed to provide targeted delivery of iodine-131 (radioisotope); CLR 121225 (CLR 225), an actinium-225 based program targeted to several solid tumors with significant unmet need, such as pancreatic cancer; and CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeting other solid tumors, such as triple-negative breast, lung, and colorectal cancers .

The company's efforts to secure regulatory approvals and advance its pipeline are subject to various risks and uncertainties, including uncertainties related to regulatory pathways, ability to execute strategic alternatives, and ability to fund operations. A complete description of these risks and uncertainties is contained in the company's periodic reports filed with the Securities and Exchange Commission .

References:
https://www.globenewswire.com/news-release/2025/09/09/3146863/29076/en/Cellectar-Biosciences-to-Participate-at-Oppenheimer-3rd-Annual-Targeted-Radiopharmaceutical-Therapies-in-Oncology-Summit.html