FDA granted RMAT designation to MB-105 for R/R CD5-positive TCL

“The FDA’s RMAT designation further validates MB-105’s potential to address a critical unmet medical need for patients with relapsed/refractory T-cell lymphoma, who face a median survival of only six months with current therapies,” said Sarah Hein, Co-Founder and Chief Executive Officer of March Biosciences. “We are encouraged by the responses observed to date and look forward to working closely with the FDA to advance MB-105 as efficiently as possible.”

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