Immix Biopharma Inc Stock Price, News & Analysis

Immix Biopharma (NASDAQ:IMMX) reported accelerated progress in its NEXICART-2 clinical trial for relapsed/refractory AL Amyloidosis. The trial has expanded to 18 clinical trial sites nationwide, marking significant advancement toward becoming the first FDA-approved cell therapy for this orphan indication.

The company presented interim results at ASCO 2025, with Dr. Heather Landau of Memorial Sloan Kettering Cancer Center leading the presentation. The expansion addresses an urgent unmet need, as currently there are no FDA-approved drugs for this condition.

Immix Biopharma (IMMX) participated in an exclusive FDA CEO Forum at FDA headquarters in Silver Spring, MD on June 5, 2025. The event, led by FDA Commissioner Marty A. Makary, M.D., M.P.H., aimed to gather input from biotech and pharmaceutical leaders on modernizing FDA's regulatory framework. The forum focused on supporting innovation and improving patient access to safe and effective therapies. Dr. Makary emphasized the importance of gathering feedback from industry leaders, while IMMX's CEO Dr. Ilya Rachman and CFO Gabriel Morris expressed appreciation for being selected alongside global pharmaceutical industry leaders to participate in this collaborative discussion.

Immix Biopharma (IMMX) announced positive interim results from its NEXICART-2 Phase 1/2 clinical trial of NXC-201 for relapsed/refractory AL Amyloidosis at ASCO 2025. The therapy met its primary endpoint with a remarkable 70% complete response rate (7/10 patients), significantly outperforming current treatments which typically achieve less than 10% CR. The remaining 3 patients showed bone marrow minimum residual disease negativity, suggesting potential future CRs. The trial demonstrated strong safety profile with no neurotoxicity, no relapses, and only low-grade cytokine release syndrome observed. Patients in the trial had received a median of 4 prior lines of therapy. Following treatment, all patients normalized pathological disease markers and showed cardiac and renal organ improvements. The company plans to submit a Biologics License Application (BLA) for FDA approval.

Immix Biopharma (IMMX) reports significant expansion of its NEXICART-2 clinical trial for relapsed/refractory AL Amyloidosis, with 14 U.S. sites now actively enrolling patients - adding 10 new sites since their last update. The company notes that patient enrollment is exceeding expectations and anticipates completing the trial ahead of schedule.

Additionally, Phase 1/2 interim readout data from the NEXICART-2 trial has been selected for oral presentation at ASCO 2025 (May 30 - June 3) in Chicago. The presentation will be delivered by Dr. Heather Landau, Director of Amyloidosis Program at Memorial Sloan-Kettering Cancer Center.

Immix Biopharma (IMMX) announced positive interim results from its NEXICART-2 Phase 1/2 clinical trial for NXC-201 in treating relapsed/refractory AL Amyloidosis. Key findings include a remarkable 71% complete response (CR) rate (5/7 patients), with the remaining 2 patients showing bone marrow minimum residual disease negativity. The trial demonstrated significant efficacy compared to current treatments, which typically show less than 10% CR rates. Notable safety outcomes include no neurotoxicity and only low-grade cytokine release syndrome lasting under 24 hours. The study involved patients with a median of 4 prior therapy lines (range: 2-9). Updated results will be presented at ASCO 2025 by Dr. Heather Landau of Memorial Sloan Kettering Cancer Center, followed by a KOL event discussing the findings.

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.