FDA Events for Immix Biopharma (IMMX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Immix Biopharma (IMMX).
Over the past two years, Immix Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
NXC-201. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
NXC-201 - FDA Regulatory Timeline and Events
NXC-201 is a drug developed by Immix Biopharma for the following indication: NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NXC-201
- Announced Date:
- July 7, 2025
- Indication:
- NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.
Announcement
Immix Biopharma, Inc. announced accelerated U.S. NEXICART-2 clinical trial progress in relapsed/refractory AL Amyloidosis.
AI Summary
Immix Biopharma, Inc. has announced accelerated progress in its U.S. NEXICART-2 clinical trial focused on treating relapsed/refractory AL Amyloidosis. The company expanded the trial’s national footprint to include 18 clinical sites. This rapid advancement is a promising step toward offering a cell therapy treatment for an underserved patient population, where no FDA-approved drugs currently exist. According to CEO Ilya Rachman, M.D., Ph.D., the progress is moving faster than expected, addressing a significant unmet need across the country. CFO Gabriel Morris added that the new sites help speed up the timeline toward submitting a Biologics License Application (BLA) for FDA approval. Interim trial results have been shared at recent medical meetings, underlining the potential of this advanced cell therapy in providing new hope for patients battling AL Amyloidosis.
Read Announcement- Drug:
- NXC-201
- Announced Date:
- June 3, 2025
- Indication:
- NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.
Announcement
Immix Biopharma, Inc. announced meeting its primary endpoint of complete response (CR) rate for cell therapy NXC-201 at an oral presentation of interim results at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025) in Chicago, Illinois.
AI Summary
Immix Biopharma recently presented promising interim results at ASCO 2025 in Chicago based on its U.S. multi-center NEXICART-2 Phase 1/2 trial of NXC-201. The cell therapy achieved a 70% complete response (CR) rate, meaning 7 out of 10 patients reached a complete remission, marking the trial’s primary endpoint. The encouraging findings include no recorded relapses and no significant safety concerns, including an absence of neurotoxicity. These outcomes highlight the potential of NXC-201 as a breakthrough treatment, especially since current options for relapsed/refractory AL Amyloidosis offer less than a 10% CR rate.
Following these results, Immix Biopharma is moving ahead with plans to file a Biologics License Application for FDA approval. A Key Opinion Leader event is scheduled to further discuss the significance of these findings, reinforcing the company’s progress toward addressing a critical unmet medical need in this challenging condition.
Read Announcement- Drug:
- NXC-201
- Announced Date:
- May 23, 2025
- Indication:
- NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.
Announcement
Immix Biopharma, Inc announced that 14 U.S. sites are actively enrolling in U.S. multi-site study NEXICART-2.
AI Summary
Immix Biopharma, Inc announced a significant milestone in its U.S. multi-site clinical trial NEXICART-2. The company reported that 14 U.S. sites are now actively enrolling patients for the study on its CAR-T cell therapy, NXC-201, targeting relapsed/refractory AL Amyloidosis. Notably, this update marks the addition of 10 new sites since the last report, reflecting growing national interest in advancing new treatment options for this serious condition.
With patient enrollment exceeding expectations, Immix Biopharma anticipates completing the NEXICART-2 trial ahead of schedule. This rapid enrollment and expansion across leading AL Amyloidosis centers underscore the commitment to fast-track innovative therapies that may offer improved outcomes for patients. The progress of the trial is seen as a promising step forward in addressing the urgent medical needs in the AL Amyloidosis community.
Read Announcement- Drug:
- NXC-201
- Announced Date:
- May 21, 2025
- Indication:
- NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.
Announcement
Immix Biopharma, Inc. announced that it will host a virtual Key Opinion Leader (KOL) event to discuss interim clinical data from the NEXICART-2 Phase 1/2 clinical trial of cell therapy NXC-201 in patients with relapsed/refractory AL Amyloidosis following its 2025 American Society of Clinical Oncology (ASCO) Oral Presentation in Chicago, IL.
AI Summary
Immix Biopharma, Inc. announced it will hold a virtual Key Opinion Leader (KOL) event to discuss interim clinical data from its NEXICART-2 Phase 1/2 trial. The trial involves NXC-201, a cell therapy being tested in patients with relapsed or refractory AL Amyloidosis. This session comes after the company’s 2025 American Society of Clinical Oncology (ASCO) Oral Presentation in Chicago, IL. The event is scheduled for Tuesday, June 3, 2025, at 3:00 pm ET, featuring a live question-and-answer session. Key speakers include Heather Landau, MD of Memorial Sloan-Kettering Cancer Center, Shahzad Raza, MD of the Cleveland Clinic, and Jeffrey Zonder, MD of Karmanos Cancer Institute. They will share their clinical insights on the new therapy and discuss how it may change treatment options for AL Amyloidosis, offering valuable information for investors and stakeholders.
Read Announcement- Drug:
- NXC-201
- Announced Date:
- February 10, 2025
- Indication:
- NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.
Announcement
Immix Biopharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted RMAT designation to sterically-optimized CAR-T NXC-201 for the treatment of relapsed/refractory AL amyloidosis.
AI Summary
Immix Biopharma recently announced that the FDA has granted RMAT designation to its sterically-optimized CAR-T cell therapy, NXC-201, for treating relapsed/refractory AL amyloidosis. This designation is based on promising proof-of-concept U.S. clinical data from the NEXICART-2 trial, emphasizing NXC-201’s potential as a new treatment option in a field with no current FDA-approved drugs. The RMAT status allows for more frequent interactions with the FDA and can help speed up the path to market through mechanisms like Accelerated Approval and Priority Review. Additionally, the enrollment pace in the NEXICART-2 trial has increased, and Immix Biopharma plans to share further updates on its progress in the first half of 2025.
Read Announcement- Drug:
- NXC-201
- Announced Date:
- January 7, 2025
- Indication:
- NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.
Announcement
Immix Biopharma, Inc. announced successful completion of the six-patient Phase 1b safety run-in segment in the U.S.
AI Summary
Immix Biopharma, Inc. announced that it has successfully completed dosing all six patients in the Phase 1b safety run-in segment of its NEXICART-2 study in the U.S. The study is testing the CAR-T therapy NXC-201 for patients with relapsed/refractory AL Amyloidosis, a serious disease affecting thousands of people. Three patients received a dose of 150 million targeted cells and three received 450 million targeted cells. All participants completed their post-dosing safety evaluations, which demonstrates a good safety profile.
This milestone now paves the way for accelerated enrollment at U.S. study sites starting in January 2025. The progress of this trial moves the company closer to providing a potential new treatment option for AL Amyloidosis, emphasizing the promising role of NXC-201 as the only one-time CAR-T therapy currently under development for this condition.
Read Announcement- Drug:
- NXC-201
- Announced Date:
- December 19, 2024
- Indication:
- NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.
Announcement
Immix Biopharma, Inc. announced initial clinical data from the first four patients in the ongoing NEXICART-2 (NCT06097832) U.S.
AI Summary
Immix Biopharma, Inc. announced promising initial clinical data from the first four patients in its ongoing U.S. NEXICART-2 trial (NCT06097832) evaluating NXC-201, a CAR-T cell therapy for relapsed/refractory AL Amyloidosis. In the study, all four patients normalized their disease markers within 30 days after dosing. Two patients have already been classified as complete responders, while the other two are bone marrow MRD negative—indicating they could soon achieve complete response. The data, with a median follow-up of 85 days, show that NXC-201 led to rapid and deep responses, with some patients normalizing markers as early as seven days post-infusion. Immix Biopharma plans to continue enrolling patients and will provide further updates in the first half of 2025, as they further evaluate the therapy’s potential benefits for patients with preserved heart function.
Read Announcement- Drug:
- NXC-201
- Announced Date:
- December 16, 2024
- Indication:
- NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.
Announcement
Immix Biopharma, Inc. announced that the Journal of Clinical Oncology (JCO) published NXC-201 clinical results in relapsed/refractory AL Amyloidosis.
AI Summary
Immix Biopharma, Inc. announced that the Journal of Clinical Oncology published the promising clinical results of NXC-201, a new CAR-T therapy for relapsed/refractory AL Amyloidosis. In the ex-U.S. NEXICART-1 trial, 16 patients who previously underwent multiple treatment lines received NXC-201, resulting in a 75% complete response rate. The therapy produced rapid and deep responses even in frail, heavily pre-treated patients and showed a favorable safety profile with minimal adverse effects.
These results mark a significant step for NXC-201 as a potential new treatment option for patients with relapsed/refractory AL Amyloidosis, a condition with limited treatment choices. With these encouraging findings published in JCO, Immix Biopharma is building on this success through further U.S. studies targeting patients with preserved heart function, aiming to confirm the long-term benefits and safety of NXC-201.
Read Announcement- Drug:
- NXC-201
- Announced Date:
- October 2, 2024
- Indication:
- NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.
Announcement
Immix Biopharma, Inc. announced advances in the NEXICART-2 clinical study of its CAR-T NXC-201 for relapsed/refractory AL Amyloidosis, a plasma cell disorder that leads to progressive damage to the heart, kidney and liver, which currently affects approximately 33,000 patients in the U.S. Immix Biopharma's sterically-optimized CAR-T NXC-201 is the only one-time CAR-T treatment option being studied for relapsed/refractory AL Amyloidosis in U.S. clinical trials.
AI Summary
Immix Biopharma, Inc. announced significant progress in its NEXICART-2 clinical study evaluating CAR-T therapy NXC-201 for relapsed/refractory AL Amyloidosis. This plasma cell disorder causes progressive damage to the heart, kidney, and liver and impacts approximately 33,000 patients in the U.S. The study, now advancing at a dose expansion level of 450 million CAR+T cells, follows an initial successful cohort at 150 million cells, where complete responses were observed in prior clinical studies. NXC-201 is currently the only one-time CAR-T treatment option being studied for relapsed/refractory AL Amyloidosis in U.S. clinical trials. Spearheaded at Memorial Sloan Kettering Cancer Center among other sites, the trial reflects strong investigator enthusiasm and a promising step forward toward a new treatment option for patients facing this significant unmet medical need.
Read Announcement- Drug:
- NXC-201
- Announced Date:
- August 28, 2024
- Indication:
- NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.
Announcement
Immix Biopharma, Inc. announced the addition of three additional clinical trial sites for its U.S. relapsed/refractory AL Amyloidosis clinical trial NEXICART-2.
AI Summary
Immix Biopharma, Inc. has expanded its U.S. clinical trial footprint for the relapsed/refractory AL Amyloidosis study NEXICART-2 by adding three new sites. The newly added centers are Cleveland Clinic, UC Davis, and Sutter Health, which will work alongside Memorial Sloan Kettering Cancer Center (MSKCC), the lead clinical site. This Phase 1b/2 trial focuses on evaluating the safety and efficacy of the CAR-T therapy NXC-201 in patients with AL Amyloidosis who have adequate cardiac function and have not been treated with BCMA-targeted therapy. The addition of these top-tier clinical sites is expected to increase patient access and enrollment opportunities while enhancing the quality of data collected. Immix Biopharma’s expanded network underscores its commitment to advancing treatment options for patients with this challenging condition.
Read Announcement- Drug:
- NXC-201
- Announced Date:
- July 25, 2024
- Indication:
- NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.
Announcement
Immix Biopharma, Inc. announced that the California Institute for Regenerative Medicine (CIRM) has awarded Immix Biopharma cell therapy division Nexcella an $8 million CLIN2 grant award to support clinical development of chimeric antigen receptor T-cell (CAR-T) therapy NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.
AI Summary
Immix Biopharma, Inc. announced that its cell therapy division, Nexcella, has been awarded an $8 million CLIN2 grant by the California Institute for Regenerative Medicine (CIRM). This funding is aimed at supporting the clinical development of their innovative chimeric antigen receptor T-cell (CAR-T) therapy, NXC-201, designed for patients with relapsed/refractory AL Amyloidosis. AL Amyloidosis is a rare disease with high unmet medical needs, as current treatment options often have severe side effects and limited long-term success. The grant from CIRM highlights the promise of NXC-201 as a one-time treatment that could potentially offer improved tolerability and sustained remissions for patients. Immix Biopharma plans to further evaluate the safety and efficacy of NXC-201 in ongoing clinical trials, building on positive preliminary data that supports its potential use in this difficult-to-treat condition.
Read Announcement- Drug:
- NXC-201
- Announced Date:
- July 8, 2024
- Indication:
- NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.
Announcement
Immix Biopharma, Inc announced that the 1st patient has been dosed at MSKCC in its U.S. NEXICART-2 trial with NXC-201, a sterically-optimized BCMA-targeted CAR-T cell therapy..
AI Summary
Immix Biopharma, Inc. announced that the first patient has been dosed at Memorial Sloan Kettering Cancer Center (MSKCC) in its U.S. NEXICART-2 trial. The trial is testing NXC-201, a sterically optimized BCMA-targeted CAR-T cell therapy, designed to treat relapsed/refractory AL Amyloidosis. Patients enrolled in this study must have adequate cardiac function and have not received prior BCMA-targeted treatments. The trial will help evaluate the safety and effectiveness of NXC-201 in a patient group with limited treatment options.
Positive results from the earlier ex-U.S. NEXICART-1 study, which reported a 92% overall response rate, have built excitement for NXC-201. Healthcare professionals are hopeful that this one-time CAR-T cell therapy could provide a new treatment option for AL Amyloidosis patients who have exhausted other therapies, marking an important step in advancing care for this challenging condition.
Read Announcement- Drug:
- NXC-201
- Announced Date:
- May 10, 2024
- Indication:
- NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.
Announcement
Immix Biopharma, Inc. announced new clinical data from its Phase 1b/2a NEXICART-1 (NCT04720313) study of novel, autologous, sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy, NXC-201, in patients with relapsed/refractory AL Amyloidosis (R/R ALA) in a late breaking oral presentation at the 27th Annual Meeting of The American Society of Gene and Cell Therapy (ASGCT) in Baltimore, MD. All patients were relapsed/refractory to standards-of-care Dara-CyBorD (daratumumab combined with cyclophosphamide, bortezomib, and dexamethasone).
Read Announcement- Drug:
- NXC-201
- Announced Date:
- April 29, 2024
- Indication:
- NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.
Announcement
Immix Biopharma, Inc. announced that the European Commission (EC) has granted orphan drug designation to NXC-201 for the treatment of multiple myeloma.
AI Summary
Immix Biopharma, Inc. announced a major development for its cell therapy candidate NXC-201, as the European Commission has granted it orphan drug designation for the treatment of multiple myeloma. This special status provides benefits such as 10 years of market exclusivity upon approval in the EU, access to the centralized authorization process, and reduced fees related to various regulatory procedures. These incentives aim to support the development of treatments for rare and underserved conditions.
The designation highlights the potential of NXC-201 to address the unmet needs of frail patients suffering from relapsed/refractory multiple myeloma. Company leaders noted that the favorable safety profile observed in the ongoing NEXICART-1 clinical trial underscores NXC-201’s promise as a valuable treatment option. This development reinforces the clinical potential of NXC-201 in a patient population with limited alternatives.
Read Announcement- Drug:
- NXC-201
- Announced Date:
- April 15, 2024
- Indication:
- NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis.
Announcement
Immix Biopharma announced that updated NXC-201 clinical data has been selected for presentation at the upcoming 27th Annual Meeting of The American Society of Gene & Cell Therapy (ASGCT) to be held in Baltimore May 7-11, 2024.
AI Summary
Immix Biopharma announced that updated clinical data for its next-generation CAR-T therapy, NXC-201, will be featured at the 27th Annual Meeting of The American Society of Gene & Cell Therapy (ASGCT) in Baltimore from May 7-11, 2024. This presentation will focus on the ongoing progress of NXC-201 in treating relapsed/refractory AL amyloidosis, a serious condition where abnormal plasma cells cause life-threatening organ damage. The clinical data, drawn from the ongoing NEXICART-1 Phase 1b/2a trial, highlights the potential of NXC-201 as a one-time treatment option for patients facing limited choices. Notably, the data aims to offer insight into the safety, dosing, and preliminary efficacy of this innovative CAR-T cell therapy, marking a significant advancement in treatment strategies for AL amyloidosis and showcasing Immix Biopharma’s commitment to pioneering cell therapy solutions.
Read Announcement
Immix Biopharma FDA Events - Frequently Asked Questions
As of now, Immix Biopharma (IMMX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Immix Biopharma (IMMX) has reported FDA regulatory activity for NXC-201.
The most recent FDA-related event for Immix Biopharma occurred on July 7, 2025, involving NXC-201. The update was categorized as "Provided Update," with the company reporting: "Immix Biopharma, Inc. announced accelerated U.S. NEXICART-2 clinical trial progress in relapsed/refractory AL Amyloidosis."
Currently, Immix Biopharma has one therapy (NXC-201) targeting the following condition: NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:IMMX) was last updated on 7/12/2025 by MarketBeat.com Staff
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