Immix Biopharma Receives U.S. FDA Breakthrough Therapy Designation for NXC-201

Core Insights - The FDA has granted Breakthrough Therapy Designation to NXC-201 for the treatment of relapsed/refractory AL Amyloidosis based on positive interim clinical results from the NEXICART-2 Phase 2 trial [1][3][4] Company Overview - Immix Biopharma, Inc. is recognized as the global leader in relapsed/refractory AL Amyloidosis, focusing on developing innovative therapies for this condition [9] - The company’s lead candidate, NXC-201, is a sterically-optimized BCMA-targeted CAR-T cell therapy designed to filter out non-specific activation and teach the immune system to eliminate toxic light chains [8][9] Clinical Development - NEXICART-2 is an ongoing multi-site U.S. Phase 2 clinical trial aimed at enrolling 40 patients to evaluate the efficacy of NXC-201 in relapsed/refractory AL Amyloidosis [5] - Final data from the NEXICART-2 trial is expected to be released this year, followed by a planned Biologics License Application (BLA) submission [1][4] Market Context - The number of patients in the U.S. with relapsed/refractory AL Amyloidosis is projected to grow at a rate of 12% per year, reaching approximately 38,500 patients by 2026 [6] - The AL Amyloidosis market was valued at $3.6 billion in 2017 and is anticipated to reach $6 billion by 2025 [7]