U.S. FDA Breakthrough Therapy Designation for NXC-201, plus a $100 million dollar financing led by Morgan Stanley, position the company for the next phase of development.
IMMIX BIOPHARMA
(Nasdaq: IMMX)
The Global Leader in Relapsed/Refractory AL Amyloidosis
Immix Biopharma is working to overcome one of the most significant barriers to widespread CAR-T adoption: neurotoxicity. By addressing this challenge, ImmixBio aims to unlock access to CAR-T therapies in indications previously out of reach—beginning with AL Amyloidosis—and in settings where CAR-T was not previously feasible, such as the 95% of U.S. medical centers currently unable to administer these treatments.
Our Strategy Is To
Build on the proliferation of cell therapy expertise across the U.S. to deliver FDA approval submissions in AL amyloidosis and other serious diseases for NXC-201, our highly differentiated cell therapy candidate.
Demonstrate the power of overcoming neurotoxicity, divorcing the classical relationship between toxicity and efficacy.
Continue to expand into new indications and advance new cell therapies with similar transformative potential.
Download the Investor Presentation to learn more about our clinical
progress, technology, and strategic vision.
Key Reasons to Watch
Clinical momentum in the U.S.: NXC-201 is enrolling in the Phase 1/2 NEXICART-2 study across leading centers, including Memorial Sloan Kettering Cancer Center, with 18 active U.S. sites reported to date.
Strengthened balance sheet and validation: An upsized financing of roughly $100 million dollars led by Morgan Stanley provides capital for late-stage activities such as CMC, process validation, stability work, and pre-approval inspection readiness, while a tier-one lead can broaden institutional reach.
Clean neurological profile reported to date: Clinical updates cite no neurotoxicity to date, which supports continued enrollment and center expansion in a setting where neurologic events are closely watched.
Regulatory positioning: The FDA cleared the IND for NXC-201, enabling U.S. dosing, and the program holds RMAT and Orphan Drug designations that can support review efficiencies if safety and efficacy remain supportive.
Scientific leadership and platform: An expanded Scientific Advisory Board adds recognized experts from top institutions to guide development, and the N-GENIUS cell therapy platform is designed to support additional programs in serious diseases.
*NXC-201 is an investigational therapy. Safety and efficacy havenot been established.
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Immix Biopharma Receives U.S. FDA Breakthrough Therapy Designation for NXC-201
– Breakthrough Therapy Designation granted to NXC-201 based on positive NEXICART-2 Phase 2 interim clinical results, presented at the American Society of Hematology (ASH) 2025 annual meeting –
– Final data expected this year followed by planned BLA submission –
LOS ANGELES, CA, Jan. 28, 2026 (GLOBE NEWSWIRE) — Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or “IMMX”), the global leader in relapsed/refractory AL Amyloidosis, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.
Per FDA, Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.
The FDA Breakthrough Therapy designation is based on Phase 2 NXC-201 interim clinical results from the NEXICART-2 clinical trial, presented December 7, 2025 in an oral presentation at the American Society of Hematology (ASH) annual meeting in Orlando, FL.
About Immix Biopharma, Inc.
Ticker
IMMX
Market Cap
~450M
Shares Outstanding
~53M
Immix Biopharma, Inc. (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company focused on advancing innovative cell therapies. The company’s lead candidate, NXC-201, is a proprietary BCMA-targeted CAR-T therapy being evaluated for relapsed/refractory AL Amyloidosis.
NXC-201 is currently in a U.S.-based Phase 1b/2a study (NEXICART-2, NCT06097832), conducted at more than a dozen centers including Memorial Sloan Kettering Cancer Center. Initial clinical results were featured in an oral presentation at ASCO 2025 by Dr. Heather Landau of MSKCC.
The therapy has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA and Orphan Drug Designation (ODD) in both the United States and the European Union.
Market Opportunity
Relapsed/Refractory AL Amyloidosis:
No FDA-approved therapies currently available
Represents a significant unmet medical need
Estimated to be a $3B+ global market opportunity
Cell therapy may offer a new therapeutic pathway if proven safe and effective
What Is NXC-201 CAR-T Therapy?
An Investigational Approach to Cell-Based Immunotherapy
Our immune systems are designed to detect and eliminate harmful cells. However, certain diseases like AL Amyloidosis originate from the body’s own cells and may avoid detection by the immune system.
NXC-201 is an investigational BCMA-targeted CAR-T (chimeric antigen receptor T-cell) therapy designed to address this challenge. The therapy involves collecting a patient’s own T cells and genetically modifying them using proprietary technology developed by Immix Biopharma. These modified cells—NXC-201 CAR-T cells—are then reintroduced into the patient’s body, where they are intended to recognize and engage cells expressing BCMA, a protein found on certain diseased cells.
In a clinical trial setting, NXC-201 is being evaluated in patients with relapsed/refractory AL Amyloidosis. Preliminary data from early trial cohorts have shown encouraging signals, including an overall response rate (ORR) of up to 92% in patients with relapsed/refractory AL Amyloidosis. However, these results are from ongoing studies and may not predict outcomes in future participants.
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
18 Clinical Trial Sites Now Open!
72 patients dosed to date across NXC-201 studies
U.S. manufacturing successfully completed for multiple clinical batches
Clinical data presented at ASCO, ASH, IMS, and other global conferences
Advisory board includes experts from Memorial Sloan Kettering, Stanford, and Columbia
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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