Edward Tenthoff

Fanyi Zhong

Jeffrey Jones

Ahu Demir

Aydin Huseynov

Jonathan Aschoff

Ted Tenthoff

- Cellectar Biosciences announced that the European Medicines Agency (EMA) confirmed eligibility to file for Conditional Marketing Authorization (CMA) for **iopofosine I 131** as a treatment for **refractory (post-BTKi) Waldenstrom Macroglobulinemia (WM)**.  **[1279704_0001104659-25-096928_tm2528016d1_ex99-1.htm:0]** **[1279704_0001104659-25-096928_tm2528016d1_8k.htm:1]** **[1279704_0001104659-25-096928_tm2528016d1_ex99-1.htm:1]** 
- The submission for CMA is expected in **early 2026**, with potential European approval and commercial launch of iopofosine I 131 anticipated in **2027**.  **[1279704_0001104659-25-096928_tm2528016d1_ex99-1.htm:1]** 
- This initiative addresses a significant **unmet medical need** in Europe, where WM affects an estimated **35,000 to 45,000 patients**.  **[1279704_0001104659-25-096928_tm2528016d1_ex99-1.htm:1]** **[1279704_0001104659-25-096928_tm2528016d1_8k.htm:2]**

Cellectar Biosciences Announces EMA Eligibility for Conditional Marketing Authorization Filing

- Cellectar Biosciences announced that the European Medicines Agency's (EMA) Scientific Advice Working Party (SAWP) advised that a Conditional Marketing Authorization (CMA) filing for **iopofosine I 131** as a treatment for refractory (post-BTKi) Waldenstrom macroglobulinemia (WM) could be acceptable.  **[1279704_70b4257c57a04805b53c2313fdd2070d_0]** 
- The company expects to submit the CMA application in **early 2026**, with potential **European approval and commercial launch in 2027**.  **[1279704_70b4257c57a04805b53c2313fdd2070d_0]** 
- The CLOVER WaM Phase 2 study results demonstrated an **overall response rate (ORR) of 83.6%** and a **major response rate (MRR) of 58.2%** for iopofosine I 131.  **[1279704_70b4257c57a04805b53c2313fdd2070d_1]** 
- Iopofosine I 131 has been granted **PRIME designation** from the EMA, and Breakthrough Therapy, Fast Track, and Orphan Drug Designations from the U.S. FDA for r/r WM.  **[1279704_70b4257c57a04805b53c2313fdd2070d_0]** **[1279704_70b4257c57a04805b53c2313fdd2070d_1]** **[1279704_70b4257c57a04805b53c2313fdd2070d_2]**

Cellectar Biosciences (CLRB)