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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.
"We are grateful to FDA for recognizing NXC-201 as the only granted FDA Breakthrough Designation for a therapy in active development in relapsed/refractory AL Amyloidosis, where no approved therapies exist for patients today," said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, "We are looking forward to completing enrollment of NEXICART-2 with the goal of delivering this promising therapy to patients upon planned BLA submission this year."
About NEXICART-2
NEXICART-2 (NCT06097832) is an ongoing 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 expected to enroll 40 patients.
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 12% per year according to Staron, et al Blood Cancer Journal, to approximately 38,500 patients in 2026.
The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research.
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 completing enrollment of NEXICART-2; delivering this promising therapy to patients upon planned BLA submission this year; the growth in the number of patients in the U.S. with 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 enrollment will not be completed when anticipated, if completed at all; (ii) 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; (iii) the risk that Breakthrough Therapy designation will not expedite the development of NXC-201: (iv) 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, (ii) the risk that the Company may not be able to continue the NEXICART-2 multi-site U.S. Phase 1/2 clinical trial; (iii) the risk that the Company may not be able to advance to registration-enabling studies for CAR-T NXC-201 or other product candidates, (iv) that success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (v) that no drug product developed by the Company has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) 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 (vii) 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, 2025 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
