Immix Biopharma’s CAR-T Candidate NXC-201 Earns FDA Breakthrough Therapy Designation In Relapsed AL Amyloidosis

Immix Biopharma announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to NXC-201 for the treatment of relapsed or refractory AL amyloidosis, a serious and life-threatening plasma cell disorder with limited therapeutic options. The designation is intended to speed development and regulatory review for medicines that show early signs of providing meaningful clinical benefit over existing treatments.

According to the FDA, Breakthrough Therapy status is reserved for drugs targeting severe diseases for which preliminary clinical data suggest substantial improvement in important clinical endpoints. ImmixBio’s award reflects the agency’s view that NXC-201 may represent a significant advance for patients who have exhausted standard therapies.

“We are grateful to the 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 of Immix Biopharma. Gabriel Morris, Chief Financial Officer of 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.”

The decision is supported by interim Phase 2 results from the ongoing NEXICART-2 study, which Immix presented in December 2025 at the American Society of Haematology annual meeting in Orlando. The data highlighted the potential of NXC-201, a sterically optimised CAR-T therapy, in this hard-to-treat patient population.

NEXICART-2 is a multi-centre U.S. Phase 2 trial with a registrational design and plans to enrol about 40 patients with relapsed or refractory AL amyloidosis. The study continues to evaluate the therapy’s safety and efficacy as Immix advances the program toward possible regulatory submission.