RegulatoryCompany release

Cellectar targets Phase 3 start in Q1 2027 and FDA accelerated approval filing in 1H 2027

🇺🇸 Cellectar Biosciences, Inc. (CLRB) · Tue 10 Nov 2026

The company reported Q3 2026 results for iopofosine I 131 in Waldenström macroglobulinemia, citing an 87.5% response rate in patients treated directly after BTK inhibitor therapy.

Cellectar Biosciences said on 10 November 2026 that it plans to dose the first patient in a confirmatory Phase 3 trial of iopofosine I 131 in the first quarter of 2027. The drug is being developed for relapsed or refractory Waldenström macroglobulinemia.

The company also intends to submit a New Drug Application to the US Food and Drug Administration in the first half of 2027, seeking accelerated approval. Accelerated approval is a US pathway that allows earlier authorisation on the basis of a surrogate or intermediate endpoint, with confirmatory evidence required afterwards.

Cellectar highlighted subgroup data from its Phase 2b CLOVER-WaM trial. In patients treated immediately after BTK inhibitor therapy, the overall response rate was 87.5%. The summary provided does not give the size of the subgroup or further efficacy and safety details.

The company has begun preparing a Phase 1b dosimetry trial that the FDA requested. Cellectar reported cash of $24.6 million, which it expects to fund operations into the second quarter of 2027.

What it means for your team

  • Regulatory teams should note the stated timeline: Phase 3 first-patient dosing in Q1 2027 and an NDA submission for accelerated approval in 1H 2027.
  • The FDA-requested Phase 1b dosimetry trial indicates that radiation dosimetry data are part of the regulator's expectations for this radiopharmaceutical.
  • Market-access and competitive-intelligence teams should treat the 87.5% response rate as a subgroup finding in patients treated directly after BTK inhibitors, not as a result for the whole trial population.
  • The cash runway into Q2 2027 is close to the planned filing window, so financing and timeline risks are worth monitoring.

Company's press release (SEC filing): Cellectar Biosciences, Inc. ↗

Article written by VigiEye from the official source (Cellectar Biosciences, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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