On March 30, 2026 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), the global leader in relapsed/refractory AL Amyloidosis, reported that NEXICART-2 enrollment is complete, meeting Company guidance, with topline results expected in Q3 2026, followed by BLA submission and planned commercial launch.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"In AL Amyloidosis, the immune system produces toxic light chains that clog up the heart, kidney and liver, causing organ failure and death. In our trials, we have seen that one-and-done NXC-201 eliminates the source of these toxic light chains. If approved, NXC-201 would be the first FDA approved treatment for relapsed/refractory AL Amyloidosis," said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, "We are grateful to patients, families, caregivers, investigators, and credit our team’s tireless efforts. Building on our positive interim readout at ASH (Free ASH Whitepaper) 2025, topline NEXICART-2 results are expected in Q3, driving BLA submission and planned commercial launch."
In addition to meeting guidance for NEXICART-2 enrollment completion and announcing topline NEXICART-2 results expected Q3 2026, Immix has onboarded a commercial-experienced Chief Medical Officer, Richard Graydon, MD, PhD. Dr. Graydon is a board-certified hematologist-oncologist with over 20 years of experience in clinical development, most recently at Merck & Co. and Johnson & Johnson, where he led new and supplemental new drug applications and biologics license applications for 7 approved drugs including DARZALEX, CARVYKTI, KEYTRUDA, and IMBRUVICA. Dr. Graydon received his MD and PhD from Stanford University and trained at Harvard’s Massachusetts General Hospital.
About NEXICART-2
NEXICART-2 (NCT06097832) is a multi-site U.S. Phase 2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis, with a registrational design. NEXICART-2 is a 40-patient study.
About AL Amyloidosis
AL amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead continuously produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death.
The number of patients in the U.S. with relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 38,500 patients in 2026.
The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research.
About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a "digital filter" that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA.
(Press release, Immix Biopharma, MAR 30, 2026, https://immixbio.com/immix-biopharma-announces-enrollment-completion-of-bla-enabling-relapsed-refractory-al-amyloidosis-trial-nexicart-2-and-upcoming-milestones/ [SID1234664021])