March Biosciences’ MB-105 Receives the Regenerative Medicine Advanced Therapy Designation for R/R CD5+ T-Cell Lymphoma
Shots:
- The US FDA has granted RMAT designation to MB-105 for the treatment of r/r CD5-positive T-cell lymphoma
- Designation was based on the ongoing P-II trial, which showed clinical activity with a favorable safety profile; initial data to be presented at ASH’25, with additional updates expected in 2026
- March Bio will pursue clinical & commercial development of MB-105 outside the US while engaging regulators, incl. the US FDA, to define an efficient, expedited path forward as data mature
Ref: GlopbeNewsWire| Image: March Biosciences| Press Release
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