reports
Immix Biopharma Attends FDA CEO Forum in Washington DC
Immix Biopharma Attends FDA CEO Forum in Washington DC – Selected to Attend In-Person Event on June 5 led by FDA Commissioner Marty A. Makary, M.D., M.P.H. – LOS ANGELES, CA, June 06, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that it was selected by FDA, and attended, the FDA CEO forum led by FDA Commissioner Marty A. Makary, M.D., M.P.H. and team at FDA headquarters in Silver Spring, MD, on June 5, 2025....
Immix Biopharma Announces Primary Endpoint Met in positive NXC-201 Int...
Immix Biopharma Announces Primary Endpoint Met in positive NXC-201 Interim Results Presented at ASCO, Enabling Path to Best-in-Class Therapy for relapsed/refractory AL Amyloidosis Immix Biopharma today presented results at ASCO from its U.S. multi-center NEXICART-2 Phase 1/2 clinical trial of NXC-201, meeting its primary endpoint. – NXC-201 met primary endpoint with a complete response (CR) rate of 70% (7/10 patients) – – No relapses recorded to-date; no safety signals identified – – Immix plans Biologics License Application (BLA) for FDA approval – – Results were presented by Heather ...
Immix Biopharma Further Expands U.S. Clinical Sites for relapsed/refra...
Immix Biopharma Further Expands U.S. Clinical Sites for relapsed/refractory AL Amyloidosis Trial NEXICART-2 – Patient enrollment exceeding expectations – – 14 U.S. sites actively enrolling; 10 U.S. sites added since last update – – Anticipate completing NEXICART-2 clinical trial ahead of schedule – LOS ANGELES, CA, May 23, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or "IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that 14 U.S. sites are actively enroll...
Immix Biopharma Announces Positive Results for NXC-201 at ASCO Oral Pr...
Immix Biopharma Announces Positive Results for NXC-201 at ASCO Oral Presentation, Enabling Pathway to Best-in-Class Therapy for relapsed/refractory AL Amyloidosis Immix Biopharma today reported ASCO abstract results from its U.S. multi-center NEXICART-2 Phase 1/2 clinical trial of NXC-201 demonstrating strong efficacy and favorable safety. – NXC-201 demonstrated a complete response (CR) rate of 71% (5/7 patients) – – No relapses recorded to-date; no safety signals identified – – Updated results with a later data cutoff, including endpoint analysis, will be presented at ASCO by lead inves...
Immix Biopharma to Host KOL Event to Discuss NXC-201 Clinical Data Pre...
Immix Biopharma to Host KOL Event to Discuss NXC-201 Clinical Data Presented at ASCO 2025 in relapsed/refractory AL Amyloidosis – Virtual KOL Event Tuesday, June 3, 2025 3:00pm ET – – Attend the event here: – LOS ANGELES, CA, May 21, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that it will host a virtual Key Opinion Leader (KOL) event to discuss interim clinical data from the NEXICART-2 Phase 1/2 clinical t...
Immix Biopharma’s NXC-201 NEXICART-2 Clinical Trial Data Selected for ...
Immix Biopharma’s NXC-201 NEXICART-2 Clinical Trial Data Selected for Oral Presentation at ASCO 2025 — Oral presentation Tuesday, June 3, 2025 in Chicago — LOS ANGELES, April 23, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that Phase 1/2 interim readout data from its U.S. NXC-201 NEXICART-2 trial in relapsed/refractory AL Amyloidosis has been selected for oral presentation at the upcoming 2025 American Soci...
Immix Biopharma Receives FDA Regenerative Medicine Advanced Therapy (R...
Immix Biopharma Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for NXC-201, sterically-optimized CAR-T for relapsed/refractory AL Amyloidosis FDA RMAT designation follows positive proof-of-concept U.S. clinical data from the NXC-201 NEXICART-2 clinical trial in relapsed/refractory AL AmyloidosisRMAT designation potentially streamlines the path to market approval by allowing frequent interactions with FDA and routes to FDA Accelerated Approval and Priority ReviewEnrollment in NEXICART-2 study accelerating; next update planned for H1 2025 LOS ANGELES,CA, Feb. 10, 202...
Immix Biopharma Accelerates Enrollment in U.S. AL Amyloidosis Trial of...
Immix Biopharma Accelerates Enrollment in U.S. AL Amyloidosis Trial of NXC-201 CAR-T Successfully dosed 6 patients in safety run-in segment, now accelerating enrollmentPositive data from first four patients announced December 2024NXC-201 is the only one-time CAR-T therapy in development for AL AmyloidosisNext program update Q1 2025 AL Amyloidosis is a life-threatening disorder of plasma cells in the bone marrow affecting ~33,000 patients in the U.S. LOS ANGELES, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”, “IMMX”), a clinic...
Immix Biopharma Announces Positive U.S. Clinical Data From First Four ...
Immix Biopharma Announces Positive U.S. Clinical Data From First Four Patients in NEXICART-2 U.S. Trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory Light Chain (AL) Amyloidosis All four patients treated with NXC-201 normalized their disease markers within 30 days of dosing, of which, two are already classified as complete responders (CR), and the remaining two are bone marrow MRD negative (10-6); all patients remain in response as of the data cutoff of Nov 14, 2024Bone marrow MRD negativity predicts future CR; company believes remaining two patients could be confirmed as...
Journal of Clinical Oncology Publishes NXC-201 Positive Clinical Resul...
Journal of Clinical Oncology Publishes NXC-201 Positive Clinical Results in relapsed/refractory AL Amyloidosis Chimeric antigen receptor T-cell (CAR-T) cell therapy NXC-201 is a novel approach to treat relapsed/refractory AL Amyloidosis NXC-201 demonstrated compelling clinical activity, rapid and deep complete responses in frail and resistant relapsed/refractory AL Amyloidosis patients LOS ANGELES, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or “IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloido...
Immix Biopharma Announces 75% Complete Response Rate (n=16); 31.5 mont...
Immix Biopharma Announces 75% Complete Response Rate (n=16); 31.5 months Best Response Duration (ongoing) for CAR-T NXC-201 in Relapsed/Refractory AL Amyloidosis Patients at ASH 2024 75% (12/16) complete response (CR) rate observed in standard of care (Dara-CyBorD) relapsed/refractory AL Amyloidosis patients with median 4 lines of prior therapy in updated Phase 1/2 data as of December 9, 2024Best responder duration of response was 31.5 months with complete response ongoing as of December 9, 2024Conference call to discuss results Tuesday, December 10, 2024 4:30 p.m. ET at LOS ANGELES, C...
Immix Biopharma to Host Conference Call for Investors, Analysts and Me...
Immix Biopharma to Host Conference Call for Investors, Analysts and Members of the Media - Company management will provide an update on positive new developments regarding CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. Following management’s formal remarks, there will be a question-and-answer session. - Conference Call to be held Tuesday, December 10, 2024 at 4:30 p.m. Eastern Time - Interested parties can attend the conference call via Zoom using the following link: LOS ANGELES, CA, Dec. 09, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” ...
Immix Biopharma Presents Positive NXC-201 Clinical Data at 66th Americ...
Immix Biopharma Presents Positive NXC-201 Clinical Data at 66th American Society of Hematology (ASH) Annual Meeting in 16 Relapsed/Refractory AL Amyloidosis Patients 75% (12/16) complete response rate observed in relapsed/refractory AL Amyloidosis patients with median 4 prior lines of therapy Data will be presented on Monday, December 9, 2024 at 4:00 PM PT LOS ANGELES, Nov. 25, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and select immune-mediated...
- Sean Conroy
Immix Biopharma - US CAR-T trial progresses to dose expansion
Immix Biopharma’s US-based NEXICART-2 trial continues to make steady progress through the clinic, with the company reporting that the trial has advanced to the dose expansion level of 450m cells, after completing the 150m cell cohort. The Phase Ib/II trial is assessing Immix’s lead CAR-T asset NXC-201 as a first-in-class outpatient treatment for relapsed/ refractory amyloid light chain amyloidosis (r/r ALA). We highlight that both chosen doses in NEXICART-2 trial had elicited complete responses ...
Immix Biopharma Advances CAR-T NXC-201 to Expansion Cohort Dose Level ...
Immix Biopharma Advances CAR-T NXC-201 to Expansion Cohort Dose Level in U.S. AL Amyloidosis Trial NEXICART-2 Now dosing at dose expansion level of 450 million NXC-201 CAR+T cells. First cohort at 150 million CAR+T cells already successfully completed Each of these two doses have produced complete responses in prior clinical studiesLead site Memorial Sloan Kettering Cancer Center (MSKCC); 4 disclosed clinical sites so farNXC-201 is the only one-time CAR-T treatment option being studied for relapsed/refractory AL Amyloidosis in U.S. clinical trials AL Amyloidosis, a disorder of plas...
Immix Biopharma Announces Dr. Raymond Comenzo, Internationally Recogni...
Immix Biopharma Announces Dr. Raymond Comenzo, Internationally Recognized AL Amyloidosis Expert, Director of the Myeloma and Amyloid Program at Tufts Medical Center, Joins Scientific Advisory Board Dr. Comenzo was the senior author of the landmark Andromeda trial results published in the New England Journal of Medicine in 2021, resulting in the first FDA-approved therapy for AL amyloidosis Dr. Comenzo was the lead author on the landmark 2012 publication of consensus guidelines, including response criteria, for conduct and reporting of clinical trials in AL Amyloidosis ...
- Jonathan Moreland
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Immix Biopharma Expands U.S. Clinical Sites for relapsed/refractory AL...
Immix Biopharma Expands U.S. Clinical Sites for relapsed/refractory AL Amyloidosis Trial NEXICART-2 New Sites Expand Opportunities for Patient Access and Enrollment Clinical Trial Sites Added Include Cleveland Clinic, UC Davis, and Sutter Health Lead site Memorial Sloan Kettering Cancer Center (MSKCC) Data from ex-U.S. clinical trial reported at ASGCT 2024 showed a 92% overall response rate LOS ANGELES, CA, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us”, “IMMX”) (Nasdaq: IMMX), a clinical-stage biopharmaceutical company developing ce...
- Jonathan Moreland
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- Sean Conroy
Immix Biopharma - Full steam ahead with US CAR-T trial
Immix Biopharma’s second quarter was headlined by intensified clinical activity for lead CAR-T asset NXC-201 (targeting amyloid light chain amyloidosis, ALA), followed by commencement of patient dosing in the US-based NEXICART-2 trial in July 2024. With an 18- to 24-month timeline for full trial enrollment (planned n=40) and top-line data expected in Q2/Q326, we now anticipate a biological license application (BLA) to be filed in H127 (vs 2026 previously). In our view, the development path has b...
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