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LOS ANGELES - Immix Biopharma, Inc. (NASDAQ:IMMX), a clinical-stage biotech company with a market capitalization of $75.5 million, announced Friday that its sterically-optimized CAR-T cell therapy NXC-201 has demonstrated a favorable safety profile, with no neurotoxicity of any grade observed in low-volume disease patients to date. According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, though it is rapidly deploying capital for clinical development.
The company is advancing its NEXICART-2 clinical trial for relapsed/refractory AL amyloidosis, with the goal of submitting a Biologics License Application (BLA) to the FDA. If approved, NXC-201 would become the first approved cell therapy for this orphan indication. The stock has shown strong momentum, gaining over 23% year-to-date, with analysts setting a target price of $7.00, suggesting significant upside potential from the current price of $2.69.
Interim results from the NEXICART-2 trial were presented at the American Society for Clinical Oncology (ASCO) 2025 conference by Dr. Heather Landau of Memorial Sloan Kettering Cancer Center.
"We are singularly focused on completing NEXICART-2 for BLA submission, where we are accelerating progress," said Ilya Rachman, CEO of Immix Biopharma, in a press release statement.
NXC-201 has received both Regenerative Medicine Advanced Therapy designation and Orphan Drug Designation from the FDA. The European Medicines Agency has also granted it Orphan Drug Designation.
AL amyloidosis is caused by abnormal plasma cells producing misfolded proteins that accumulate in organs, leading to progressive damage and high mortality rates. According to the company, the U.S. prevalence of relapsed/refractory AL amyloidosis is growing at approximately 12% annually, reaching an estimated 33,277 patients in 2024.
The therapy is being evaluated in a U.S. multi-center study with a registrational design, suggesting the company intends to use the trial results to support regulatory approval. While InvestingPro analysis indicates the company’s overall financial health score is Fair at 2.3, subscribers can access 6 additional ProTips and comprehensive financial metrics to better evaluate the investment opportunity in this emerging biotech company.
In other recent news, Immix Biopharma, Inc. has reported significant developments in its NEXICART-2 clinical trial for the cell therapy candidate NXC-201, targeting relapsed/refractory AL amyloidosis. The trial, which has expanded to 18 sites across the United States, shows promising interim results with a 100% response rate among participants and a 70% complete response rate. The company plans to use these findings to support a future Biologics License Application submission, aiming for FDA approval. H.C. Wainwright has reiterated its Buy rating on Immix Biopharma, maintaining a price target of $7.00, citing the positive trial outcomes as a basis for their confidence. Additionally, Immix Biopharma has entered into an At The Market Offering Agreement with Citizens JMP Securities, LLC, allowing for the sale of shares of its common stock. The company’s NXC-201 has received both Regenerative Medicine Advanced Therapy designation and Orphan Drug Designation from the FDA and the European Medicines Agency. Immix Biopharma’s ongoing research and development efforts continue to attract attention from investors and industry observers. These developments reflect the company’s commitment to advancing treatment options for AL amyloidosis, a condition with significant unmet medical needs.
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