Immix Biopharma Receives U.S. FDA Breakthrough Therapy Designation for NXC-201
Rhea-AI Summary
Immix Biopharma (NASDAQ: IMMX) announced that the U.S. FDA has granted Breakthrough Therapy Designation to NXC-201 for relapsed/refractory AL amyloidosis based on positive NEXICART-2 Phase 2 interim results presented at ASH on December 7, 2025. Final NEXICART-2 data are expected in 2026, with a planned BLA submission this year. Management said the designation recognizes NXC-201 as the only FDA breakthrough granted among therapies in active development for this indication and reiterated plans to complete enrollment and pursue regulatory filing.
Positive
- FDA Breakthrough Therapy designation for NXC-201
- Phase 2 interim NEXICART-2 results presented at ASH (Dec 7, 2025)
- Planned BLA submission in 2026 following final data
- Company aims to complete trial enrollment this year
Negative
- Key data are still interim, not final
- Breakthrough designation is not FDA approval and does not guarantee BLA success
News Market Reaction
On the day this news was published, IMMX gained 3.37%, reflecting a moderate positive market reaction. Argus tracked a peak move of +5.7% during that session. Argus tracked a trough of -10.9% from its starting point during tracking. Our momentum scanner triggered 18 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $10M to the company's valuation, bringing the market cap to $310M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
IMMX gained 10.2% while close peers showed mixed moves (e.g., BYSI +5.23%, NRXP +5.16%, ACET -1.61%, IGMS -2.31%, OSTX -1.36%). Momentum scanner only flagged ALGS at -5.08%, suggesting today’s move is stock-specific rather than a broad biotech rotation.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 09 | Equity financing close | Neutral | +7.3% | Closed upsized underwritten offering raising net proceeds of about $93.7M. |
| Dec 07 | Equity financing pricing | Neutral | +10.6% | Priced upsized $100M offering of common stock and pre-funded warrants. |
| Dec 07 | Clinical data update | Positive | +10.6% | Reported positive Phase 2 NXC-201 results at ASH 2025 with strong response rates. |
| Nov 12 | Executive appointment | Positive | +15.2% | Appointed Chief Commercial Officer to lead NXC-201 launch preparations. |
| Nov 03 | Conference selection | Positive | -4.2% | Announced NEXICART-2 data selected for an oral presentation at ASH 2025. |
Recent IMMX news has mostly seen positive alignment between constructive announcements and share price, with only one notable divergence on a positive clinical update.
Over the last few months, Immix Biopharma has advanced NXC-201 clinically and financially. Positive Phase 2 NEXICART-2 data at ASH 2025 on Dec 7, 2025 and selection for oral presentation previously coincided with double‑digit percentage gains. The company strengthened its balance sheet through an upsized $100M underwritten offering in early Dec 2025, which also saw favorable price reactions. Commercial readiness progressed with a Chief Commercial Officer appointment on Nov 12, 2025. Today’s Breakthrough Therapy Designation builds directly on that clinical and strategic trajectory.
Regulatory & Risk Context
An effective Form S-3 shelf filed on Jan 09, 2026 allows Immix Biopharma to offer up to $750,000,000 of securities over time, providing significant financing flexibility for NXC-201 and other programs but also creating capacity for future equity or mixed-security issuance.
Market Pulse Summary
This announcement grants NXC-201 FDA Breakthrough Therapy Designation in relapsed/refractory AL amyloidosis, building on prior positive Phase 2 NEXICART-2 data presented at ASH on December 7, 2025. It reinforces the path toward a planned BLA submission this year. Historically, IMMX has supported NXC-201 with both clinical progress and substantial financings, including access to a $750,000,000 shelf, so future updates on final data, regulatory timelines, and funding choices remain key watchpoints.
Key Terms
breakthrough therapy designation regulatory
bla submission regulatory
relapsed/refractory medical
al amyloidosis medical
AI-generated analysis. Not financial advice.
– 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
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 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
FAQ
What does the FDA Breakthrough Therapy designation mean for Immix Biopharma (IMMX)?
On what data did the FDA grant Breakthrough Therapy to NXC-201 (IMMX)?
When does Immix Biopharma (IMMX) expect to submit a BLA for NXC-201?
How might the Breakthrough designation affect NXC-201's development timeline for IMMX?
Did Immix Biopharma (IMMX) present NEXICART-2 data publicly before the designation?
