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📣 What CLRB Says Is Next
coming months · “Sites are expected to begin opening in the coming months with first patient to be dosed in early 2027. § The Phase 3 study will be a comparator, randomized controlled study with approximately 100 WM patients per arm; full patient enrollment is projected within 18-24 months of the first patient admitted to the study. § The New Drug Application is planned for submission in mid-2027 under the FDA’s Accelerated Approval Program.”
Company press release, Aug 13, 2026 · SEC filing
mid-2027 · ““Most notably, we progressed our regulatory strategy for iopofosine I 131 in Waldenström macroglobulinemia, including initiation of site activation activities for our confirmatory Phase 3 trial, which is an important first step toward our accelerated approval application in the U.S., which we plan to submit in mid-2027.”
Company press release, Aug 13, 2026 · SEC filing
Quoted word for word from the company's press releases filed with the SEC. Timing is the company's own guidance, not a BioRadar estimate.
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Data: SEC EDGAR, FDA, ClinicalTrials.gov, Yahoo Finance • Informational purposes only, not investment advice. • All tracked stocks A–Z
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