Immix Biopharma’s NXC-201 Receives FDA RMAT Designation For AL Amyloidosis

Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on cell therapies for AL amyloidosis and immune-mediated diseases. The firm recently announced that the U.S. FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its sterically-optimized CAR-T therapy. NXC-201 is a treatment for relapsed/refractory AL amyloidosis.

Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma, said, “Receipt of FDA RMAT designation underscores the strength of our NXC-201 data and the potential for NXC-201 to provide a new treatment option for patients with relapsed/refractory AL amyloidosis, where no drugs are FDA approved today.”

Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “We are also pleased to report that the pace of enrollment in NEXICART-2 has accelerated following successful completion of the safety run-in segment. We look forward to sharing further information on our progress, including an NEXICART-2 update in the first half of 2025.”

The RMAT designation process selects only limited applications since less than half of all submissions received approval in the past eight years. To qualify, therapies must be advanced regenerative medicines targeting severe conditions, showing preliminary clinical evidence of potential to treat, modify, reverse, or cure the disease. RMAT designation helps development by enabling early feedback with the FDA and additional discussions about surrogate markers, which leads to faster approval pathways.