- Legend Biotech Corporation LEGN has announced that the FDA accepted for priority review the marketing application submitted by Janssen Biotech Inc for ciltacabtagene autoleucel (cilta-cel) for relapsed/refractory multiple myeloma.
- Cilta-cel is an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy.
- The agency's target action date has been set for November 29.
- The submission is based on results from the pivotal Phase 1b/2 CARTITUDE-1 study, which evaluated the efficacy and safety of cilta-cel.
- Updated longer-term follow-up data will be featured at the upcoming American Society of Clinical Oncology Annual Meeting next month.
- Price Action: LEGN stock closed at $37.54 on Wednesday.
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