Immix Biopharma Announces Enrollment Completion of BLA-Enabling Relapsed/Refractory AL Amyloidosis Trial NEXICART-2, and Upcoming Milestones
Rhea-AI Summary
Immix Biopharma (NASDAQ:IMMX) announced completion of enrollment in its BLA‑enabling NEXICART‑2 trial for relapsed/refractory AL amyloidosis, meeting prior guidance. Topline NEXICART‑2 results are expected in Q3 2026, followed by a planned BLA submission and intended commercial launch.
The company also appointed Dr. Richard Graydon as Chief Medical Officer; Dr. Graydon has led new and supplemental drug and biologics applications at Merck and Johnson & Johnson for multiple approved therapies.
Positive
- NEXICART‑2 enrollment complete, meeting company guidance
- Topline results expected Q3 2026, enabling next regulatory steps
- BLA submission planned after topline readout, targeting commercial launch
- Experienced CMO hired (Dr. Richard Graydon) with BLA/NDA leadership at Merck and Johnson & Johnson
Negative
- Regulatory approval contingent on NEXICART‑2 topline results expected Q3 2026
- Commercial launch conditional on successful BLA review and approval
News Market Reaction – IMMX
In the Mar 30 session, IMMX gained 5.28%, reflecting a notable positive market reaction. Argus tracked a peak move of +6.2% during that session. Argus tracked a trough of -5.2% from its starting point during tracking. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 03 | Investor conferences | Neutral | -2.5% | Participation in March 2026 healthcare investor conferences and one-on-one meetings. |
| Jan 28 | Regulatory designation | Positive | +3.4% | FDA Breakthrough Therapy Designation for NXC-201 in relapsed/refractory AL amyloidosis. |
| Dec 09 | Equity financing close | Positive | +2.0% | Closing of upsized underwritten offering raising about $93.7M net for NXC-201 and corporate uses. |
| Dec 07 | Equity financing pricing | Positive | +10.6% | Pricing of upsized $100M offering of common stock and pre-funded warrants under S-3 shelf. |
| Dec 07 | Clinical data update | Positive | +10.6% | Positive Phase 2 NXC-201 ASH 2025 results with high CR and organ response rates. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent IMMX news—clinical progress, designations, and financings—has generally coincided with positive price reactions, indicating a history of constructive trading around value-adding milestones.
Over the last six months, IMMX has combined clinical progress in NXC-201 with significant financings. On Dec 7–9, 2025, positive Phase 2 AL amyloidosis data and a $100 million upsized offering drove gains of 10.61% and 1.97%. Breakthrough Therapy Designation on Jan 28, 2026 saw shares rise 3.37%. A March 10-K detailed continued losses but a strengthened balance sheet after late-2025 raises. Today’s enrollment-completion update and BLA timeline fit this pattern of advancing NXC-201 toward registration.
Key Terms
fda regulatory
biologics license applications regulatory
hematologist-oncologist medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
– Full enrollment of BLA-enabling trial complete, per prior guidance –
– Topline NEXICART-2 Results Expected Q3 2026, followed by BLA submission and planned commercial launch –
– Onboarded Chief Medical Officer, formerly of Merck and Johnson & Johnson for BLA submission –
LOS ANGELES, CA, March 30, 2026 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), the global leader in relapsed/refractory AL Amyloidosis, today announced that NEXICART-2 enrollment is complete, meeting Company guidance, with topline results expected in Q3 2026, followed by BLA submission and planned commercial launch.
“In AL Amyloidosis, the immune system produces toxic light chains that clog up the heart, kidney and liver, causing organ failure and death. In our trials, we have seen that one-and-done NXC-201 eliminates the source of these toxic light chains. If approved, NXC-201 would be the first FDA approved treatment for relapsed/refractory AL Amyloidosis,” said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “We are grateful to patients, families, caregivers, investigators, and credit our team’s tireless efforts. Building on our positive interim readout at ASH 2025, topline NEXICART-2 results are expected in Q3, driving BLA submission and planned commercial launch.”
In addition to meeting guidance for NEXICART-2 enrollment completion and announcing topline NEXICART-2 results expected Q3 2026, Immix has onboarded a commercial-experienced Chief Medical Officer, Richard Graydon, MD, PhD. Dr. Graydon is a board-certified hematologist-oncologist with over 20 years of experience in clinical development, most recently at Merck & Co. and Johnson & Johnson, where he led new and supplemental new drug applications and biologics license applications for 7 approved drugs including DARZALEX, CARVYKTI, KEYTRUDA, and IMBRUVICA. Dr. Graydon received his MD and PhD from Stanford University and trained at Harvard’s Massachusetts General Hospital.
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 40-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 the global leader in relapsed/refractory 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 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 topline NEXICART-2 results expected Q3 2026, followed by BLA submission and planned commercial launch; NXC-201 being the possible first FDA approved treatment for relapsed/refractory AL Amyloidosis; 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, ivi) that success in early phases of pre-clinical and clinicals trials do not ensure later 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
