Shares of Immix Biopharma Inc. (IMMX) are up nearly 20% at $6.65 in pre-market trade, following presentation of positive results of phase 2 portion of its NEXICART-2 trial in relapsed/refractory AL Amyloidosis at the American Society of Hematology 2025 Annual Meeting yesterday.
NEXICART-2 is a single-arm multi-site U.S. phase I/II clinical trial of NXC-201 in relapsed/refractory AL Amyloidosis. The primary endpoint of the phase I portion of the study is safety, and that of the phase II portion is efficacy.
AL amyloidosis is a rare and serious disease caused by abnormal plasma cells in the bone marrow that produce misfolded amyloid proteins. These proteins build up in vital organs, such as the heart, kidneys, and liver, leading to progressive, multi-organ damage. It is also associated with high mortality rates.
In the phase 2 portion, the results of which were presented yesterday, NXC-201 demonstrated a complete response (CR) rate of 75% by independent review committee. In four out of five pending patients, MRD negativity in bone marrow predicts future complete response, potentially increasing future CR rate to 95%, according to the company. (MRD negativity means no measurable residual disease).
Given that current therapies deliver complete response rates of 10% or below in relapsed/refractory AL amyloidosis (Zanwar et al., 2024), this level of response could represent a meaningful improvement and address a major unmet need.
The company anticipates a final data readout from the NEXICART-2 trial and plans to submit the BLA in 2026.
If approved, NXC-201 could become the first approved therapy in the challenging indication of relapsed/refractory AL Amyloidosis.
Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, "This exciting Phase 2 milestone brings us one step closer to delivering this promising therapy to patients upon planned BLA submission in 2026."
When we alerted readers to IMMX on September 11, 2025, it was trading around $2.20.
The stock closed Friday's (December 5, 2025) trading at $5.56, up 14.88 %.
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