Last mentioned: Mar 25, 2026
Potential EU Launch
Target window for commercial availability of iopofosine I 131 in Europe.
Target Commercialization
Anticipated EU launch for iopofosine I 131 treatment of WM.
EMA Submission
Planned filing of Conditional Marketing Authorization for iopofosine I 131.
EMA Submission
Target window for filing the CMA for iopofosine I 131 in the European Union.
CLR 125 Data
Expected early data readout from Phase 1b study in triple-negative breast cancer.
CLR 125 Data Readout
Expected early data from the Phase 1b study in Triple Negative Breast Cancer.
Phase III Initiation
First patient dosed at Peking Union Medical College Hospital in China.
Phase III Initiation
First patient dosed at Peking Union Medical College Hospital in China.
Financial Results
Company reports 2025 results and provides corporate update.
Annual Results Announcement
CEO James Caruso provides corporate updates and confirms regulatory timelines.
Regulatory Designations
FDA grants Fast Track and NMPA grants Breakthrough Therapy status.
Regulatory Designations
HMI-115 receives FDA Fast Track and NMPA Breakthrough Therapy designations.
Trial Expansion
Continued enrollment across global multicenter sites for the 24-week study.
Fiscal Year End
Cellectar completes a year of pipeline advancement and platform validation.
Fiscal Year End
Cellectar concludes a year focused on pipeline execution and supply chain strengthening.
Phase II Data Publication
Results showing efficacy without hormonal side effects published in The Lancet.
Phase II Completion
Global multicenter Phase II trial results published in The Lancet showing efficacy and safety.
Hope Medicine Inc. has initiated dosing in its Phase III clinical trial for HMI-115, a first-in-class non-hormonal monoclonal antibody for endometriosis. This milestone marks the first time a non-hormonal treatment for this condition has reached Phase III development globally, offering a potential alternative to traditional hormonal therapies.
Hope Medicine Inc. has initiated Phase III dosing for HMI-115, the first non-hormonal monoclonal antibody for endometriosis to reach this clinical stage. This milestone, supported by FDA Fast Track and NMPA Breakthrough designations, signals a potential shift away from traditional hormone-suppressing therapies in women's health.
Texas Governor Greg Abbott has launched a formal investigation into the safety and security of medical devices manufactured in China and used within the state's healthcare system. The move signals a growing trend of state-level scrutiny over international medical supply chains and potential vulnerabilities in critical healthcare infrastructure.
Cellectar Biosciences has confirmed its trajectory for a Q3 2026 regulatory submission to the EMA for its lead radiotherapeutic, iopofosine I 131. The company is simultaneously advancing its Phase 1b study of CLR 125 in triple-negative breast cancer, marking a significant expansion of its phospholipid drug conjugate platform.
Cellectar Biosciences has announced its 2025 year-end results, highlighting a strategic shift toward European commercialization for its lead radiotherapeutic, iopofosine I 131. The company remains on track for a Q3 2026 regulatory submission to the EMA, while simultaneously advancing its Phase 1b study for CLR 125 in triple-negative breast cancer.