Immix Biopharma announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.

 “We are grateful to FDA for recognising NXC-201 as the only granted FDA Breakthrough Designation for a therapy in active development in relapsed/refractory AL Amyloidosis, where no approved therapies exist for patients today,” said Ilya Rachman, MD, PhD, Chief Executive Officer, Immix Biopharma.

The FDA Breakthrough Therapy designation is based on phase-II NXC-201 interim clinical results from the NEXICART-2 clinical trial, presented on 7 December, 2025 in an oral presentation at the American Society of Hematology (ASH) annual meeting in Orlando, FL.

Gabriel Morris, Chief Financial Officer, Immix Biopharma, added, “We are looking forward to completing enrollment of NEXICART-2 with the goal of delivering this promising therapy to patients upon planned BLA submission this year.”