Cellectar Biosciences to Present at Oppenheimer Summit, Highlights Progress with EMA and FDA for Iopofosine I 131 in Waldenstrom Macroglobulinemia, Plans to Initiate Phase 1b Clinical Trial for Auger-Emitting Radiopharmaceutical in TNBC.

Cellectar Biosciences will participate at Oppenheimer's 3rd Annual Targeted Radiopharmaceutical Therapies in Oncology Summit. The company is making progress with the European Medicines Agency for a potential Conditional Marketing Authorization submission for iopofosine I 131 to treat Waldenstrom Macroglobulinemia. They plan to pursue accelerated approval with the FDA and are advancing an Auger-emitting radiopharmaceutical product candidate into a Phase 1b clinical trial for triple-negative breast cancer in Q4 2025.

Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company, will participate in the upcoming Oppenheimer 3rd Annual Targeted Radiopharmaceutical Therapies in Oncology Summit on September 11, 2025, in New York City. The company will be meeting with investors to discuss its recent progress and future plans, including updates on its pipeline of cancer treatments.

Cellectar has made notable advancements with the European Medicines Agency (EMA) regarding a potential Conditional Marketing Authorization (CMA) submission for iopofosine I 131, a drug candidate designed to treat Waldenstrom Macroglobulinemia (WM). The company provided data from its Phase 2b CLOVER WaM clinical trial, which demonstrated a statistically significant major response rate and meaningful duration of response for patients with hematologic malignancies treated with iopofosine I 131. A final decision from the EMA on their recommendation for a CMA submission is expected in late 3Q25/Early 4Q25 .

Cellectar also plans to pursue an accelerated approval with the U.S. Food and Drug Administration (FDA) for iopofosine I 131 as a treatment for WM. The submission would be supported by data from the Phase 2b CLOVER WaM clinical trial, including the FDA-requested 12-month follow-up results and new subset analyses .

Additionally, Cellectar is advancing 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. CLR 125 is an iodine-125 Auger-emitting drug candidate targeting solid tumors such as TNBC, lung, and colorectal cancers .

The company's president and CEO, Jim Caruso, expressed optimism about the progress with the EMA and the potential for a fast track, conditional marketing authorization approval. He also highlighted the company's strong progress with its novel phospholipid drug conjugate pipeline and the planned Phase 1b trial for CLR 125 .

Cellectar Biosciences is focused on leveraging its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments. The company's product pipeline includes iopofosine I 131, CLR 225, and CLR 125, among other assets .

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