Immix Biopharma Announces 95% Complete Response Rate in Interim Update From relapsed/refractory AL Amyloidosis Clinical Trial NEXICART-2
Rhea-AI Summary
Immix Biopharma (IMMX) reported an interim update from its relapsed/refractory AL Amyloidosis trial NEXICART-2.
The NXC-201 therapy shows a 95% complete response (CR) rate (19/20 patients), with all CRs achieved within 1 year, no relapses among CR patients to date, and all later patients with available data MRD-negative at one month. A multi-center randomized Phase 3 in newly diagnosed patients is planned, with the next NEXICART-2 update expected in late September 2026 and 1-year follow-up data targeted by end of March 2027.
AI-generated analysis. Not financial advice.
Positive
- NEXICART-2 complete response rate 95% (19 of 20 patients)
- All complete responses achieved within 1 year of follow-up post-dosing
- No relapses observed so far among patients who reached complete response
- All later patients with available data are MRD-negative at one month
- Data support plan for multi-center randomized Phase 3 trial in newly diagnosed AL Amyloidosis
- Company expects 1-year follow-up data by March 2027 to support BLA submission and launch
Negative
- None.
News Market Reaction – IMMX
On the day this news was published, IMMX declined 3.02%, reflecting a moderate negative market reaction. Argus tracked a peak move of +6.5% during that session. Argus tracked a trough of -17.7% from its starting point during tracking. Our momentum scanner triggered 28 alerts that day, indicating elevated trading interest and price volatility. This price movement removed approximately $15M from the company's valuation, bringing the market cap to $486.44M at that time. Trading volume was very high at 4.5x the daily average, suggesting heavy selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
IMMX gained 0.9% while peers were mixed: ACET +7.03%, BYSI +11.2%, OSTX +2.23%, IGMS -2.31%, NRXP -1.66%. Moves appear stock-specific, not a broad sector rotation.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 07 | ASH 2025 Phase 2 data | Positive | +10.6% | Reported 75% CR rate with potential rise to 95% and strong safety profile. |
| Nov 03 | ASH oral selection | Positive | -4.2% | NEXICART-2 interim results selected for ASH 2025 oral presentation. |
| Sep 18 | Enrollment milestone | Positive | +6.6% | Surpassed 50% enrollment in NEXICART-2, advancing toward first cell therapy BLA. |
| Jul 07 | Trial acceleration | Positive | +2.8% | Reported accelerated NEXICART-2 progress and expansion to 18 trial sites. |
| Jun 03 | Primary endpoint met | Positive | -18.9% | Announced primary endpoint met with 70% CR rate and strong safety at ASCO. |
Clinical updates often led to strong but inconsistent reactions, with both sharp gains and notable selloffs on positive data.
Over the past year, IMMX has repeatedly highlighted progress in its NEXICART‑2 trial for NXC‑201 in relapsed/refractory AL amyloidosis. Clinical updates from Jun 03, 2025 through the ASH 2025 oral data on Dec 07, 2025 showed rising complete response rates, strong safety, and growing investigator interest. Price reactions ranged from a -18.85% drop on primary endpoint success to a 10.61% gain on ASH efficacy data, underscoring volatile, sometimes contrarian trading around similar clinical catalysts.
Historical Comparison
In the past year, IMMX released 5 NEXICART‑2 clinical updates with an average move of -0.61%, showing that even strong data often produced uneven trading responses.
Clinical updates show progression from early interim NEXICART‑2 data to ASCO and ASH 2025 results with rising CR rates and expanding trial scale, supporting the move toward registrational studies.
Regulatory & Risk Context
An effective Form S-3 shelf filed on Jan 09, 2026 allows Immix to issue up to $750,000,000 in various securities over time, with one recorded usage via a 424B5 prospectus. This structure gives the company significant flexibility to raise capital as NXC‑201 advances.
Market Pulse Summary
This announcement highlights a very high 95% complete response rate in 20 relapsed/refractory AL amyloidosis patients, with all CRs achieved within 1 year and no relapses reported to date. It extends a sequence of NEXICART‑2 updates that have previously driven volatile price moves. Investors may watch for the late September 2026 update, planned Phase 3 initiation, and the end‑March 2027 one‑year follow‑up data that management expects to support a BLA submission.
Key Terms
mrd-negative medical
complete response (cr) medical
al amyloidosis medical
phase 3 trial medical
bla submission regulatory
frontline therapy medical
organ failure medical
multi-center, randomized medical
AI-generated analysis. Not financial advice.
– Of first 20 patients, all four MRD-negative patients have converted to complete response (CR) –
– CR rate now
– All CRs reached within 1 year of follow-up post-dosing –
– No relapses to-date observed for patients who have reached CR –
– All subsequently enrolled patients for whom MRD results are available are MRD-negative at one month –
– Next NEXICART-2 Update Expected Late September, 2026 –
LOS ANGELES, May 21, 2026 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a global leader in AL Amyloidosis, today announced that all four relapsed/refractory AL Amyloidosis MRD-negative patients presented at ASH 2025 have converted to complete response (CR). The NEXICART-2 CR rate is now
These results support the Company’s plan to initiate a multi-center, randomized Phase 3 trial in newly diagnosed AL Amyloidosis patients.
“Even in a heavily pretreated population of median 4 prior lines of therapy, we are pleased that NXC-201, as a 5th line of therapy, drives MRD-negativity, converting to durable CRs to-date, indicating that NXC-201 can eliminate the source of toxic light chains that clog up the heart, kidney and liver, causing organ failure and death in relapsed/refractory AL Amyloidosis. As a potential frontline therapy in AL Amyloidosis, we believe there’s potential to transform a usual 2-year treatment, into a one-and-done: NXC-201.” Gabriel Morris, President, Chief Financial Officer of Immix Biopharma, added, “We have observed the NEXICART-2 CR rate improving over time. In September 2026 we plan to present updated data from our ongoing NEXICART-2 trial. By end of March 2027, we expect to present 1-year follow-up data of enrolled patients, which we expect will drive BLA submission and commercial launch.”
About NEXICART-2
NEXICART-2 (NCT06097832) is a multi-site U.S. Phase 2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis, with a registrational design. NEXICART-2 is a 45-patient study.
About AL Amyloidosis
AL amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead continuously produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death.
The number of patients in the U.S. with relapsed/refractory AL Amyloidosis is estimated to be growing at
The Amyloidosis market was
About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a “digital filter” that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA.
About Immix Biopharma, Inc.
Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a global leader in AL Amyloidosis. AL Amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a “digital filter” that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT06097832), with a potentially registrational design. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA.
Forward Looking Statements
This press release contains forward-looking statements regarding Immix Biopharma, Inc., its results of operations, prospects, future business plans and operations and the matters discussed above, including, but not limited to, statements relating to upcoming NEXICART-2 results and our expectations surrounding the durability of clinical response, timing and expectations relating to our planned BLA submission and commercial launch thereafter, if approved; the size of the AL Amyloidosis market; the potential benefits of our product candidate CAR-T NXC-201 and the timing and results related to clinical trials. These statements involve risks and uncertainties, and actual results may differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements also include, but are not limited to, our plans, objectives, expectations and intentions and other statements that contain words such as “expects”, “contemplates”, “anticipates”, “plans”, “intends”, “believes”, “estimates”, “potential”, and variations of such words or similar expressions that convey the uncertainty of future events or outcomes, or that do not relate to historical matters. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the estimates for the number of patients in the U.S. with relapsed/refractory AL Amyloidosis and the market size reaching not being accurate; (ii) the risk that Breakthrough Therapy designation will not expedite the development of NXC-201; (iii) the risk that further data from the ongoing Phase 1/2 clinical trials for CAR-T NXC-201 will not be favorably consistent with the data readouts to date; (iv) the risk that the Company may not be able to continue the NEXICART-2 multi-site U.S. Phase 1/2 clinical trial; (v) the risk that the Company may not be able to advance to registration-enabling studies for CAR-T NXC-201 or other product candidates; (vi) that success in early phases of pre-clinical and clinicals trials do not ensure data from such clinical trials, or subsequent clinical trials will be successful; (vii) that no drug product developed by the Company has received FDA pre-market approval or otherwise been incorporated into a commercial drug product; (viii) the risk that the Company may not be able to obtain additional working capital with which to continue the clinical trials for CAR-T NXC-201, or advance to the initiation of registration-enabling studies, for such product candidates as and when needed and (ix) those other risks disclosed in the section “Risk Factors” included in the Company’s Annual Report on Form 10-K filed with the SEC on March 25, 2026, and other periodic or current reports subsequently filed with the Securities and Exchange Commission. These reports are available at www.sec.gov. Immix Biopharma cautions that the foregoing list of important factors is not complete. Immix Biopharma cautions readers not to place undue reliance on any forward-looking statements. Immix Biopharma does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.
Contacts
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
Company Contact
irteam@immixbio.com
