Cellectar's Iopofosine Shows 79.2% Major Response in BTKi-Refractory WM, Phase 3 and NDA Planned
CLRB is trading near its 52-week low of $1.8 (0.0% below the low).
Summary
Cellectar announced compelling efficacy data from a Phase 2 CLOVER WaM subset analysis of iopofosine I 131 in Waldenström Macroglobulinemia patients refractory/resistant to BTK inhibitor therapy. The data show a Major Response Rate of 79.2%, Overall Response Rate of 87.5%, and Duration of Response exceeding 16 months in this heavily pretreated population. The company plans to advance to a Phase 3 confirmatory trial in early 2027 and file an NDA for accelerated approval in 1H27, with potential approval by end of 2027 given Breakthrough Therapy Designation. This is the first disclosure of these specific efficacy numbers and the regulatory timeline, representing a significant positive development for a micro-cap biotech trading near its 52-week low. The data will be presented at IWWM on October 15, 2026.
At the time of this announcement, CLRB was trading at $1.80 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $17.3M. The 52-week trading range was $1.80 to $6.52. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.