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     233  0 Kommentare Immix Biopharma Awarded European Union Orphan Drug Designation for NXC-201 in Multiple Myeloma - Seite 2

    About Immix Biopharma, Inc.
    Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and other autoimmune diseases. Our lead cell therapy is FDA IND cleared next generation CAR-T NXC-201, currently being evaluated in our ongoing Phase 1b/2 NEXICART-1 (NCT04720313) clinical trial, initiated in February 2021. NXC-201 has the potential to be the world’s first “Single-Day CRS” CAR-T (CRS median onset day 1, median duration 1 day), enabling the potential for a faster return home for patients and supporting ongoing expansion into autoimmune indications. NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma, and ODD by the European Commission (EMA) in AL Amyloidosis. Learn more at www.immixbio.com and www.BeProactiveInAL.com.

    Forward Looking Statements
    This press release contains forward-looking statements regarding Immix Biopharma, Inc., including the potential benefits of our initial product candidates, CAR-T NXC-201 and IMX-110. Forward-looking statements 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 further data from the ongoing Phase 1b/2a clinical trials for CAR-T NXC-201 and IMX-110 will not be favorably consistent with the initial data initial data readouts, (ii) the risk that the Company may not be able to advance to registration-enabling studies for the CAR-T NXC-201 and IMX-110 product candidates, (iii) success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (iv) no drug product developed by the Company has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) 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 IMX-110, 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 29, 2024 and other periodic reports subsequently filed with the Securities and Exchange Commission. 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.

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    Immix Biopharma Awarded European Union Orphan Drug Designation for NXC-201 in Multiple Myeloma - Seite 2 European Orphan Drug Designation (“ODD”) qualifies NXC-201 for: 10 years of market exclusivity once authorized in the EUAccess to the EU centralized authorization procedureReduced fees for: EU protocol assistance, marketing authorization …