Immix Biopharma (IMMX) announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to NXC-201 for the treatment of relapsed/refractory AL Amyloidosis. The FDA Breakthrough Therapy designation is based on Phase 2 NXC-201 interim clinical results from the NEXICART-2 clinical trial, presented December 7, 2025 in an oral presentation at the American Society of Hematology (ASH) annual meeting in Orlando, FL.
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