Welcome to our dedicated page for Immix Biopharma news (Ticker: IMMX), a resource for investors and traders seeking the latest updates and insights on Immix Biopharma stock.
Immix Biopharma, Inc. (Nasdaq: IMMX) generates a steady flow of news as a clinical-stage biopharmaceutical company advancing cell therapies for relapsed/refractory AL amyloidosis and other serious diseases. The company describes itself as a global leader in this rare blood disorder, and its news coverage reflects progress in clinical development, regulatory interactions, capital formation and corporate governance.
Many Immix Biopharma news items focus on its lead BCMA-targeted CAR-T cell therapy, NXC-201, and the ongoing NEXICART-2 clinical trial in relapsed/refractory AL amyloidosis. Press releases highlight interim and Phase 2 results, including complete response rates, organ responses and safety observations, as well as the selection of NXC-201 data for oral presentations at major conferences such as ASH and ASCO. The company also reports on regulatory designations for NXC-201, including RMAT and Orphan Drug Designation from U.S. and European authorities.
Investors following IMMX news will also see announcements about equity financings, including registered underwritten offerings and private placements of common stock and warrants, together with stated uses of proceeds for NXC-201 development and general corporate purposes. Additional coverage includes board and management changes, such as the appointment of experienced biotechnology leaders to the board of directors and the addition of a Chief Commercial Officer to prepare for potential commercialization of NXC-201.
This news page aggregates company press releases and related updates so readers can track Immix Biopharma’s clinical milestones, financing activities, conference presentations and strategic appointments over time.
Immix Biopharma (IMMX) has announced a virtual Key Opinion Leader (KOL) event scheduled for June 3, 2025, at 3:00pm ET. The event will discuss interim clinical data from the NEXICART-2 Phase 1/2 clinical trial of their cell therapy NXC-201 in patients with relapsed/refractory AL Amyloidosis, following its presentation at the 2025 American Society of Clinical Oncology (ASCO) conference.
The event will feature prominent experts including Dr. Heather Landau from Memorial Sloan-Kettering Cancer Center, Dr. Shahzad Raza from Cleveland Clinic, and Dr. Jeffrey Zonder from Karmanos Cancer Institute. These specialists will share their clinical experience with NXC-201 and discuss the evolving treatment landscape for AL Amyloidosis. A live Q&A session will follow the presentation.
Immix Biopharma (IMMX) announced that Phase 1/2 interim data from its NXC-201 NEXICART-2 trial in relapsed/refractory AL Amyloidosis has been selected for oral presentation at ASCO 2025. The presentation, titled 'Safety and efficacy data from NEXICART-2, the first US trial of CAR-T in R/R light chain (AL) amyloidosis, NXC-201,' will be delivered by Dr. Heather Landau, Director of Amyloidosis Program at Memorial Sloan-Kettering Cancer Center.
The presentation is scheduled for Tuesday, June 3, 2025, between 9:45am and 12:45pm CDT in Chicago, as part of the Oral Abstract Session on Hematologic Malignancies—Plasma Cell Dyscrasia (Abstract #7508).
Immix Biopharma (NASDAQ: IMMX) has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for NXC-201, their sterically-optimized CAR-T therapy for relapsed/refractory AL Amyloidosis. This designation follows positive proof-of-concept U.S. clinical data from the NEXICART-2 trial.
The RMAT designation, granted to less than half of applications in the past eight years, potentially accelerates the path to market approval through frequent FDA interactions and routes to Accelerated Approval and Priority Review. NXC-201 is currently the only CAR-T therapy in development for AL Amyloidosis, addressing an area with no FDA-approved drugs.
The company reports accelerated enrollment in the NEXICART-2 study following successful completion of the safety run-in segment, with the next update planned for H1 2025.
Immix Biopharma (NASDAQ: IMMX) has successfully completed the six-patient Phase 1b safety run-in segment of its NEXICART-2 study for NXC-201, a CAR-T therapy targeting AL Amyloidosis. The trial, which evaluated three patients at 150 million CAR-T cells and three at 450 million cells, is now advancing to accelerated enrollment across U.S. study sites in January 2025.
The NEXICART-2 study consists of two segments: the completed six-patient safety run-in and a 34-patient dose expansion segment. NXC-201 is currently the only CAR-T therapy in development for AL Amyloidosis, a life-threatening disorder affecting approximately 33,000 patients in the U.S. The company previously announced positive data from the first four patients in December 2024 and expects to provide the next program update in Q1 2025.
Immix Biopharma (IMMX) reported positive initial clinical data from the first four patients in its NEXICART-2 U.S. trial of NXC-201 CAR-T therapy for relapsed/refractory AL Amyloidosis. All four patients normalized their disease markers within 30 days of treatment, with two achieving complete response (CR) and two showing bone marrow MRD negativity. The trial, which began enrollment in June 2024, is the only ongoing CAR-T clinical trial for AL Amyloidosis in the United States.
Patients received either 150 million (three patients) or 450 million (one patient) CAR+T cells. The treatment showed favorable tolerability with no severe adverse events, cytokine-release syndrome, and no neurotoxicity. The company plans to continue enrollment with interim data expected in Q2/Q3 2025 and final topline results in Q2/Q3 2026.
Immix Biopharma (IMMX) announced the publication of positive clinical results for its CAR-T cell therapy NXC-201 in the Journal of Clinical Oncology. The study, conducted outside the U.S., involved 16 patients with relapsed/refractory AL Amyloidosis who had received a median of 4 prior treatments. The therapy demonstrated a 75% complete response rate (12/16 patients) and showed a favorable safety profile in frail patients.
The company is currently conducting a U.S. trial focusing on patients with preserved heart function, excluding those with pre-existing heart failure. The U.S. multi-site trial, which began in mid-2024, is currently dosing at the expansion cohort level. Notably, there are currently no FDA-approved drugs for relapsed/refractory AL Amyloidosis.
Immix Biopharma (IMMX) has presented updated Phase 1/2 clinical data for NXC-201 in treating relapsed/refractory AL Amyloidosis at ASH 2024. The study showed a 75% complete response rate (12/16 patients) with a median of 4 prior therapy lines. The best responder maintained a complete response for 31.5 months ongoing.
Key results from 16 patients include: 94% overall response rate, 62% organ response rate, and favorable safety profile with no ICANS events. Patient characteristics showed 81% had cardiac involvement, 38% had NYHA stage 3/4 heart failure, and 31% had Mayo stage 3 AL amyloidosis. The treatment demonstrated manageable cytokine release syndrome with a median duration of 2 days.
Immix Biopharma (IMMX) has announced a conference call scheduled for Tuesday, December 10, 2024, at 4:30 p.m. Eastern Time. The call will feature company management providing updates on positive new developments regarding CAR-T NXC-201 in relapsed/refractory AL Amyloidosis.
The clinical-stage biopharmaceutical company, which focuses on developing cell therapies for AL Amyloidosis and select immune-mediated diseases, will host the call via Zoom. Following management's formal presentation, attendees will have the opportunity to participate in a question-and-answer session.
Immix Biopharma (IMMX) announced positive clinical data for NXC-201 in treating relapsed/refractory AL Amyloidosis patients, achieving a 75% complete response rate (12/16 patients) with median 4 prior lines of therapy. The data will be presented at the 66th American Society of Hematology (ASH) Annual Meeting in San Diego on December 9, 2024. NXC-201 is highlighted as the only CAR-T therapy in development for this condition, demonstrating promising results in this underserved patient population.
Immix Biopharma (IMMX) has advanced its CAR-T therapy NXC-201 to the expansion cohort dose level in the U.S. NEXICART-2 trial for AL Amyloidosis. The study is now dosing at 450 million NXC-201 CAR+T cells, following successful completion of the first cohort at 150 million cells. Both doses have previously produced complete responses in clinical studies.
NXC-201 is the only one-time CAR-T treatment being studied for relapsed/refractory AL Amyloidosis in U.S. clinical trials. The NEXICART-2 study, led by Memorial Sloan Kettering Cancer Center, aims to evaluate the safety and efficacy of NXC-201 in patients with adequate cardiac function who haven't received prior BCMA-targeted therapy.
Previous data from an ex-US study showed a 92% overall response rate and a 28.0 month duration of response. AL Amyloidosis, affecting approximately 33,000 patients in the U.S., currently has no FDA-approved drugs for relapsed/refractory cases.