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Immix Biopharma Announces Enrollment Completion of BLA-Enabling Relapsed/Refractory AL Amyloidosis Trial NEXICART-2, and Upcoming Milestones

  • Immix Biopharma completed full enrollment of the registrational NEXICART-2 trial for NXC-201 in relapsed/refractory AL Amyloidosis.
  • Topline results for NEXICART-2 are expected in Q3 2026, followed by a BLA submission & planned commercial launch.
  • Immix Biopharma onboarded Richard Graydon, MD, PhD, as Chief Medical Officer to lead the BLA submission; he previously led applications for seven approved drugs at Merck & Johnson & Johnson.
  • NEXICART-2 is a 40-patient Phase 2 multi-site U.S. study evaluating the sterically-optimized BCMA-targeted CAR-T therapy NXC-201.
  • NXC-201 has received Breakthrough Therapy Designation, Regenerative Medicine Advanced Therapy (RMAT), & Orphan Drug Designation from the FDA & EMA.
  • The U.S. patient population for relapsed/refractory AL Amyloidosis is estimated to reach approximately 38,500 in 2026.
  • If approved, NXC-201 would be the first FDA-approved treatment for relapsed/refractory AL Amyloidosis.