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CLRB Cellectar Biosciences INC

Cellectar Biosciences Inc is a clinical-stage biopharmaceutical company. It is focused on the discovery, development, and commercialization of drugs for the treatment of cancer. The company's core objective is to leverage a proprietary phospholipid drug conjugate (PDC) delivery platform to develop PDCs that are designe…

Assets on file: iopofosine I 131

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January 2032

Jan 2032

~ Jan 2032

CLRBCellectar Biosciences INC NEW

iopofosine I 131: Phase 3 trial NCT07766421 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

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Decision-gradeMaterialNotableMinor

Aug 13, 2026

11:25 AM

CLRBCellectar Biosciences INC NEW

Cellectar plans NDA submission for iopofosine I 131 in r/r WM in mid-2027

The company initiated site activation for the confirmatory Phase 3 trial of iopofosine I 131 and announced plans to submit an NDA under the FDA’s Accelerated Approval Program in mid-2027. The filing will be supported by data from the CLOVER WaM Phase 2b study showing a 79.2% major response rate and 16-month median duration of response in relapsed/refractory Waldenström macroglobulinemia patients.

Application submittedSEC 8-K Open record

Nov 13, 2025

12:30 PM

CLRBCellectar Biosciences INC NEW

Cellectar receives RPDD for iopofosine I 131 in r/r pHGG

The company received Rare Pediatric Drug Designation for iopofosine I 131 in inoperable relapsed/refractory pediatric high-grade glioma. This designation adds to the existing six Orphan Drug, five Rare Pediatric Drug, and two Fast Track Designations already granted by the FDA for various cancer indications.

FDA designationSEC 8-K

Oct 6, 2025

11:15 AM

CLRBCellectar Biosciences INC NEW

Cellectar: EMA SAWP confirms CMA eligibility for iopofosine I 131 in WM

The SAWP advised that iopofosine I 131 meets eligibility requirements for a Conditional Marketing Authorization submission in the post-BTKi WM population. The company now plans to file the CMA application in early 2026, with potential European approval and launch in 2027.

EMA opinionSEC 8-K Open record