95% complete response rate reported in the first 20 NEXICART-2 patients, full 45-patient enrollment completed, and a $150 million financing position ImmX for its next clinical and regulatory milestones.
IMMIX BIOPHARMA
(Nasdaq: IMMX)
A Potential First-in-Class CAR-T Opportunity in Relapsed/Refractory AL Amyloidosis
Immix Biopharma is advancing NXC-201, an investigational, sterically optimized BCMA-targeted CAR-T therapy for relapsed/refractory AL amyloidosis. In the company’s May 2026 interim update, 19 of the first 20 NEXICART-2 patients had achieved a complete hematologic response, representing a reported 95% complete response rate. Enrollment of all 45 patients has been completed, with the next clinical update expected in late September 2026.
NXC-201 is investigational. Safety and efficacy have not been established, and results from an interim patient group may not predict final trial outcomes.
IMMX's Strategy Is To
Advance the fully enrolled NEXICART-2 study toward its next 45-patient clinical update and a planned Biologics License Application submission.
Evaluate whether NXC-201 can deliver deep hematologic responses with a tolerability profile suited to patients whose disease may already affect the heart, kidneys or liver.
Expand the NXC-201 opportunity through a planned frontline Phase 3 study and potential development in additional serious diseases.
Download the July 2026 investor presentation for updated NEXICART-2 clinical results, the 45-patient development timeline, the company’s planned regulatory pathway and its strategy for expanding NXC-201.
Key Reasons to Watch
*NXC-201 is an investigational therapy. Safety and efficacy havenot been established.
95% complete response rate reported: In the May 2026 interim update, 19 of the first 20 NEXICART-2 patients had achieved a complete hematologic response. All complete responses were reached within one year following dosing.
No reported relapses among complete responders as of the update: The company stated that no relapses had been observed among patients who had reached complete response as of May 21, 2026. Longer follow-up and results from the full study remain necessary.
The BLA-enabling study is fully enrolled: All 45 patients in NEXICART-2 were enrolled by March 2026, shifting the program from enrollment execution toward data maturation and regulatory preparation.
Next clinical update expected in late September 2026: ImmixBio plans to report an update covering all 45 enrolled NEXICART-2 patients.
Multiple FDA designations: NXC-201 has received Breakthrough Therapy, Regenerative Medicine Advanced Therapy and U.S. Orphan Drug designations, as well as Orphan Drug Designation in the European Union. These designations may facilitate regulatory interaction but do not assure approval.
Approximately $140.65 million in new net proceeds: ImmixBio closed a $150 million underwritten common-stock offering in May 2026, adding capital for clinical, manufacturing, regulatory and commercial-readiness activities.
Frontline development planned: The company is planning NEXICART-3, a randomized Phase 3 study of NXC-201 in newly diagnosed AL amyloidosis, with trial initiation targeted for the first half of 2027.
Fill Out The Form Below To Receive Our Latest Presentation Deck And Stay Up To Date on Immix Biopharma.
Immix Biopharma Reports 95% Complete Response Rate in Interim NEXICART-2 Update
– 19 of the first 20 patients achieved a complete hematologic response –
– All complete responses reached within one year following dosing –
– No relapses reported among complete responders as of the May 2026 update –
– Next 45-patient update expected in late September 2026 –
LOS ANGELES, May 21, 2026 — Immix Biopharma announced that all four previously MRD-negative patients presented at ASH 2025 had converted to complete response, bringing the reported NEXICART-2 complete response rate to 95%, or 19 of the first 20 patients. The company reported that all complete responses were reached within one year after dosing and that no relapses had been observed to date among patients who had reached complete response.
ImmixBio also reported that all subsequently enrolled patients with available MRD results were MRD-negative at one month. The next NEXICART-2 update is expected in late September 2026.
About Immix Biopharma, Inc.
Ticker
IMMX
Market Cap
~472M
Shares Outstanding
~55.4M
Immix Biopharma, Inc. (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company developing cell therapies for AL amyloidosis and other serious diseases. Its lead candidate, NXC-201, is an investigational, sterically optimized BCMA-targeted CAR-T therapy designed to eliminate the plasma cells responsible for producing toxic light chains.
NXC-201 is being evaluated in NEXICART-2, a U.S. multi-center Phase 1/2 study in relapsed/refractory AL amyloidosis. Enrollment of all 45 patients was completed in March 2026. In a May 2026 interim update, the company reported that 19 of the first 20 patients had achieved a complete hematologic response. The next update is expected in late September 2026.
NXC-201 has received Breakthrough Therapy Designation, Regenerative Medicine Advanced Therapy designation and Orphan Drug Designation from the FDA, along with Orphan Drug Designation in the European Union. NXC-201 has not been approved by the FDA or any other regulatory authority.
Significant Unmet Need in Relapsed/Refractory AL Amyloidosis
Relapsed/Refractory AL Amyloidosis:
No therapy is currently FDA approved specifically for relapsed/refractory AL amyloidosis.
The company estimates approximately 30,500 U.S. patients are living with relapsed/refractory disease.
Current off-label treatment approaches have produced low complete-response rates in cited retrospective datasets.
A one-time cell therapy capable of generating deep and durable responses could represent a meaningful new treatment option, if NXC-201 is ultimately proven safe and effective and receives regulatory approval.
ImmixBio estimates a potential U.S. annual commercial opportunity of approximately $1.7 billion, based on management assumptions regarding eligible patients and future pricing. Actual market size, treatment adoption and pricing may differ materially.
What Is NXC-201?
An Investigational, One-Time BCMA-Targeted CAR-T Therapy
AL amyloidosis begins when abnormal plasma cells produce misfolded light-chain proteins. These toxic proteins can accumulate in vital organs, including the heart, kidneys and liver, causing progressive organ damage.
NXC-201 is an investigational autologous CAR-T therapy. A patient’s T cells are collected and engineered to recognize BCMA, a protein expressed on the plasma cells responsible for producing the toxic light chains. The modified cells are then returned to the patient with the goal of eliminating the underlying source of disease.
NXC-201 incorporates a sterically optimized CAR design that the company describes as a “digital filter,” intended to reduce nonspecific activation while preserving anti-disease activity. That design hypothesis continues to be evaluated in clinical studies.
NXC-201 is an investigational product. It has not been approved by the FDA or any regulatory authority. Safety and efficacy have not been established.
Clinical Progress & Scientific Momentum
45 Patients Enrolled: Enrollment in NEXICART-2 completed in March 2026
95% Complete Response Rate
U.S. manufacturing successfully completed for multiple clinical batches
3 FDA Designations:
Breakthrough Therapy, RMAT and Orphan Drug Designations
$140.65M Net Proceeds
From the May 2026 underwritten offering
Discover Immix Biopharma’s progress and potential
Immix Biopharma is working to bring new hope to patients with serious and difficult-to-treat diseases through the development of NXC-201. Backed by regulatory designations, early clinical data, and a strong institutional network, the company is advancing one of the few clinical-stage CAR-T programs focused on AL Amyloidosis.
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