Cellectar BioSciences Reports Q3 2025 Financial Results and Advances Oncology Pipeline

Reuters

2025/11/13

Cellectar BioSciences Reports Q3 2025 Financial Results and Advances Oncology Pipeline

Cellectar BioSciences Inc. reported its third quarter 2025 financial results and provided a corporate update. The company announced plans to submit a Conditional Marketing Approval application in Europe for iopofosine I 131 in refractory (post-BTKi) Waldenstrom's Macroglobulinemia in 2026, following guidance from the Scientific Advice Working Party of the European Medicines Agency. Cellectar also plans to submit a New Drug Application to the U.S. FDA for accelerated approval of iopofosine I 131 for Waldenstrom's Macroglobulinemia once a confirmatory trial is underway, contingent on sufficient funding. During the quarter, the company initiated a Phase 1b study of CLR 125 for triple-negative breast cancer and received Rare Pediatric Drug Designation for iopofosine I 131 in inoperable relapsed/refractory pediatric high-grade glioma. Additionally, Cellectar's early-stage asset, CLR 225, completed IND-enabling studies after demonstrating anti-tumor activity in pancreatic cancer models.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cellectar BioSciences Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9575106-en) on November 13, 2025, and is solely responsible for the information contained therein.

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The company announced plans to submit a Conditional Marketing Approval application in Europe for iopofosine I 131 in refractory (post-BTKi) Waldenstrom's Macroglobulinemia in 2026, following guidance from the Scientific Advice Working Party of the European Medicines Agency. Cellectar also plans to submit a New Drug Application to the U.S. FDA for accelerated approval of iopofosine I 131 for Waldenstrom's Macroglobulinemia once a confirmatory trial is underway, contingent on sufficient funding. During the quarter, the company initiated a Phase 1b study of CLR 125 for triple-negative breast cancer and received Rare Pediatric Drug Designation for iopofosine I 131 in inoperable relapsed/refractory pediatric high-grade glioma. 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ID: GNW9575106-en) on November 13, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251113:nNDL5l21ff:1","article_id":"2583567878","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2583567878","pubTimestamp":1763036426,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. 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The company announced plans to submit a Conditional Marketing Approval application in Europe for iopofosine I 131 in refractory (post-BTKi) Waldenstrom's Macroglobulinemia in 2026, following guidance from the Scientific Advice Working Party of the European Medicines Agency. Cellectar also plans to submit a New Drug Application to the U.S. FDA for accelerated approval of iopofosine I 131 for Waldenstrom's Macroglobulinemia once a confirmatory trial is underway, contingent on sufficient funding. During the quarter, the company initiated a Phase 1b study of CLR 125 for triple-negative breast cancer and received Rare Pediatric Drug Designation for iopofosine I 131 in inoperable relapsed/refractory pediatric high-grade glioma. Additionally, Cellectar's early-stage asset, CLR 225, completed IND-enabling studies after demonstrating anti-tumor activity in pancreatic cancer models.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cellectar BioSciences Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9575106-en) on November 13, 2025, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"dataReport,express","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}