Immix Biopharma Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for NXC-201, sterically-optimized CAR-T for relapsed/refractory AL Amyloidosis

LOS ANGELES,CA, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”, “IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL amyloidosis and select immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted RMAT designation to sterically-optimized CAR-T NXC-201 for the treatment of relapsed/refractory AL amyloidosis. As of June 2024 public information, FDA approved less than half of RMAT applications submitted to the agency during the last eight years. FDA RMAT designation requires that a drug is an advanced regenerative medicine, targets a serious condition, with the potential to treat, modify, reverse, or cure, and preliminary clinical evidence has indicated that the drug has the potential to address these unmet medical needs.