U.S. Food and Drug Administration

Company

Last mentioned: Mar 25, 2026

Timeline

  1. Potential EU Launch

    Target window for commercial availability of iopofosine I 131 in Europe.

  2. EMA Submission

    Planned filing of Conditional Marketing Authorization for iopofosine I 131.

  3. CLR 125 Data

    Expected early data readout from Phase 1b study in triple-negative breast cancer.

  4. Phase III Initiation

    First patient dosed at Peking Union Medical College Hospital in China.

  5. Financial Results

    Company reports 2025 results and provides corporate update.

  6. Regulatory Designations

    FDA grants Fast Track and NMPA grants Breakthrough Therapy status.

  7. Phase II Data Publication

    Results showing efficacy without hormonal side effects published in The Lancet.

  8. Fiscal Year End

    Cellectar completes a year of pipeline advancement and platform validation.

Stories mentioning U.S. Food and Drug Administration 2

market-trends Bullish

Cellectar Biosciences Targets 2027 EU Launch for Iopofosine I 131

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.

2 sources

About U.S. Food and Drug Administration coverage

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