83.6% ORR and 61.8% MRR achieved in heavily pretreated population with median duration of response of 17.8 months
FDA-requested dataset with ≥12-month follow-up on all patients strengthens regulatory positioning for accelerated approval and supports initiation of confirmatory trial in 4Q26
Compelling efficacy observed in post-BTKi patients, including ~64% MRR and durable responses exceeding 18 months
Recently Announced Oversubscribed Financing of up to $140 Million with Leading Healthcare Institutional Investors Supports Confirmatory Study and NDA Filing for Accelerated Approval of Iopofosine I 131 in Waldenström Macroglobulinemia with the FDA
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