Immix Biopharma surpasses 50% enrollment milestone in AL amyloidosis trial

Published 18/09/2025, 18:38
Immix Biopharma surpasses 50% enrollment milestone in AL amyloidosis trial

LOS ANGELES - Immix Biopharma, Inc. (NASDAQ:IMMX), a clinical-stage biotech company with a market capitalization of $64 million, announced Thursday that it has surpassed the 50% enrollment milestone in NEXICART-2, its clinical trial evaluating NXC-201 for relapsed/refractory AL amyloidosis.

The multi-site U.S. Phase 1/2 trial has a registrational design and is expected to enroll a total of 40 patients. Interim results from the study were presented at the American Society for Clinical Oncology (ASCO) annual meeting in 2025. According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt, though it is rapidly consuming cash reserves as it advances its clinical programs.

NXC-201 is a BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy that has received Regenerative Medicine Advanced Therapy designation from the FDA and Orphan Drug Designation from both U.S. and European regulators.

"Surpassing 50% enrollment in NEXICART-2 demonstrates the growing interest among relapsed/refractory AL amyloidosis clinicians and patients, where no drugs are FDA approved today," said Ilya Rachman, Chief Executive Officer of Immix Biopharma, in a press release statement.

AL amyloidosis is a condition caused by abnormal plasma cells that produce misfolded proteins, which build up in organs and can lead to heart and kidney failure. The U.S. prevalence of relapsed/refractory AL amyloidosis is estimated to be growing at 12% annually, reaching approximately 37,270 patients in 2025.

The company is continuing enrollment toward a planned Biologics License Application submission to the FDA. Trading at $2.13 per share, IMMX stock has experienced an 11.7% decline over the past week, though it remains up 10.1% over the last year. InvestingPro analysis indicates the stock is currently overvalued, with analysts setting an $8 price target. Subscribers can access 5 additional ProTips and comprehensive financial metrics to better evaluate IMMX’s investment potential.

In other recent news, Immix Biopharma, Inc. announced significant developments that are of interest to investors. The company reported that its NXC-201 CAR-T cell therapy has shown a favorable safety profile, with no neurotoxicity observed in patients with low-volume disease. This advancement is part of their ongoing NEXICART-2 clinical trial for relapsed/refractory AL amyloidosis, with plans to submit a Biologics License Application to the FDA. In addition, Immix Biopharma has received a strategic investment from Goose Capital, with Dr. Nancy T. Chang joining its Board of Directors. Dr. Chang brings extensive pharmaceutical development experience, having led the development of several FDA-approved medications at Tanox, Inc. Furthermore, Immix Biopharma plans to partner out its CAR-T therapy programs for diseases beyond its lead indication. In response to these developments, H.C. Wainwright raised its price target for Immix Biopharma to $8.00 from $7.00, maintaining a Buy rating on the stock. The firm highlighted the company’s accelerated progress in its U.S. NEXICART-2 clinical trial.

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