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LOS ANGELES - Immix Biopharma, Inc. (NASDAQ: IMMX), a clinical-stage biotechnology company with a current market capitalization of $72.48 million, has announced positive results from its Phase 1/2 NEXICART-2 clinical trial for NXC-201, a cell therapy targeting AL Amyloidosis. The trial met its primary endpoint with a complete response rate of 70%, with no relapses or safety concerns reported to date. According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, though it’s currently not profitable.
The interim results from the multi-center U.S. trial were presented by Heather Landau, MD, of Memorial Sloan Kettering Cancer Center at the American Society of Clinical Oncology Annual Meeting in Chicago, Illinois. The data cutoff for the presented results was April 11, 2025. The positive trial results have contributed to IMMX’s impressive 31.98% stock price increase over the past week. Want deeper insights? InvestingPro subscribers have access to over 10 additional key metrics and analysis tools.
NXC-201 demonstrated a complete response in 7 out of 10 patients, and the remaining 3 patients showed bone marrow minimum residual disease negativity, which may predict future complete responses. Following treatment, all patients normalized pathological disease markers and showed clinical improvements in cardiac and renal functions.
The current treatments for relapsed/refractory AL Amyloidosis typically yield less than a 10% complete response rate, highlighting a significant unmet medical need in this patient population.
Immix Biopharma plans to submit a Biologics License Application (BLA) for FDA approval based on these findings. The company’s CEO, Ilya Rachman, MD, PhD, expressed that the trial’s results underscore the potential of NXC-201 to become the first approved therapy for this challenging indication.
The NEXICART-2 trial aims to enroll 40 patients with preserved heart function who have not received prior BCMA-targeted therapy. The primary endpoint for the Phase 1 portion of the trial is safety, while the Phase 2 portion focuses on efficacy.
NXC-201 has been granted Regenerative Medicine Advanced Therapy (RMAT) by the FDA and Orphan Drug Designation in both the US and EU.
The press release also notes that the U.S. observed prevalence of relapsed/refractory AL Amyloidosis is increasing, and the Amyloidosis market is expected to grow to $6 billion by 2025. Wall Street analysts appear optimistic about IMMX’s potential, setting a target price of $7 per share. InvestingPro analysis indicates the stock is currently trading near its Fair Value, with additional financial health metrics available to subscribers.
This article is based on a press release statement from Immix Biopharma, Inc.
In other recent news, Immix Biopharma has made notable advancements in its NEXICART-2 clinical trial for AL Amyloidosis. The company has accelerated the trial’s enrollment, now actively engaging 14 U.S. sites, a significant increase from previous updates. Immix Biopharma reported promising interim results, revealing a complete response rate of 71% with no relapses, and a favorable safety profile for the NXC-201 therapy. Notably, the trial showed that all participants normalized pathological disease markers, with complete responses in 5 out of 7 patients. The therapy has been granted Regenerative Medicine Advanced Therapy and Orphan Drug Designation by the FDA and EMA, underscoring its potential impact. Safety assessments indicated no serious adverse events, only low-grade cytokine release syndrome lasting less than 24 hours. Detailed results are anticipated at the American Society of Clinical Oncology Annual Meeting in 2025, where Dr. Heather Landau will present further findings. Immix Biopharma’s progress highlights a significant development in addressing the unmet need for effective AL Amyloidosis treatments.
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