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Immix Biopharma's NXC-201 achieved a 70% complete response rate in its NEXICART-2 Phase 1/2 trial for relapsed/refractory AL Amyloidosis. The therapy demonstrated a strong safety profile with no neurotoxicity and improved cardiac and renal functions in all patients. Immix Biopharma plans to submit a Biologics License Application for FDA approval.

Immix Biopharma, Inc. (NASDAQ:IMMX) has reported promising results from its NEXICART-2 Phase 1/2 clinical trial of NXC-201, a cell therapy for relapsed/refractory AL amyloidosis. The trial, presented at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025), achieved a 70% complete response (CR) rate, surpassing the typical CR rate of less than 10% for existing treatments [1, 2].

NXC-201 demonstrated a strong safety profile, with no neurotoxicity and only low-grade cytokine release syndrome observed. The therapy also improved cardiac and renal functions in all patients, suggesting significant clinical benefits [1, 2].

Immix Biopharma plans to submit a Biologics License Application (BLA) for FDA approval following the successful trial results. The company is preparing for a Key Opinion Leader (KOL) event to discuss the implications of these findings on Tuesday, June 3, 2025, at 3:00 pm ET [1, 2].

The trial involved ten patients and met its primary endpoint with a CR rate of 70%. No relapses have been recorded to date, indicating the potential of NXC-201 as a viable treatment option for this severe condition. The results underscore the therapy's efficacy and safety profile, positioning it favorably in a market with limited FDA-approved agents [1, 2].

Investors and financial professionals should closely monitor Immix Biopharma's progress as it moves towards FDA approval and potential commercialization of NXC-201. The company's stock has seen recent insider and institutional activity, suggesting interest in the company's prospects [1, 2].

References:
[1] https://finance.yahoo.com/news/h-c-wainwright-reiterates-buy-203346352.html
[2] https://www.nasdaq.com/articles/immix-biopharma-reports-70-complete-response-rate-nxc-201-phase-1-2-al-amyloidosis-trial