Core Insights - Immix Biopharma, Inc. has announced a class-leading safety profile for its CAR-T therapy NXC-201, with no neurotoxicity observed in low-volume disease to date, which supports potential future indication expansion [1][3] - The company is focused on completing the NEXICART-2 study for Biologics License Application (BLA) submission, aiming for FDA approval [2][3] - The U.S. prevalence of relapsed/refractory AL Amyloidosis is projected to grow at 12% annually, reaching approximately 33,277 patients by 2024, with the amyloidosis market expected to increase from $3.6 billion in 2017 to $6 billion by 2025 [5] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company developing cell therapies specifically for AL Amyloidosis and other serious diseases [3] - The lead candidate, NXC-201, is a sterically-optimized BCMA-targeted CAR-T cell therapy designed to filter out non-specific activation [3] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation (ODD) from both the FDA and EMA [3] Industry Context - AL Amyloidosis is caused by abnormal plasma cells producing misfolded amyloid proteins, leading to organ damage and high mortality rates [4] - The market for amyloidosis treatments is expected to grow significantly, indicating a rising demand for effective therapies [5]

Core Insights - Immix Biopharma is advancing its NEXICART-2 clinical trial for relapsed/refractory AL Amyloidosis, expanding to 18 sites in the U.S. [1][2] - The company is on track for the first Biologics License Application (BLA) for a cell therapy targeting an unaddressed orphan indication [1][2] - Interim results from the NEXICART-2 trial were presented at ASCO 2025, showcasing the progress of the therapy [1][2][3] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [3] - The lead candidate is NXC-201, a BCMA-targeted CAR-T cell therapy, currently evaluated in a multi-center study [3] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation (ODD) from the FDA and EMA [3] Market Context - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% annually, reaching approximately 33,277 patients by 2024 [5] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [5]

NXC-201 Platform and Clinical Trial - NXC-201 is a sterically-optimized CAR-T construct from the Immix N-GENIUS platform with a "digital filter" to reduce non-specific activation and enhance tolerability[6] - The company plans to submit a BLA for NXC-201[9] - The NEXICART-2 trial is a U S multi-center trial with registrational design for relapsed/refractory AL Amyloidosis with 40 patients enrolled[6,39] - Interim clinical data readout for the NEXICART-2 trial in relapsed/refractory AL Amyloidosis is expected in 2Q 2025[35] - Planned NEXICART-2 enrollment completion is expected in 4Q 2025 / 1Q 2026[35] AL Amyloidosis Market and NXC-201 Potential - The relapsed/refractory AL Amyloidosis target market has a U S patient prevalence of 34,600, representing a multi-billion dollar value[6] - There are currently no FDA-approved drugs for relapsed/refractory AL Amyloidosis[6,27] - Current standards of care induce a complete response in 0-10% of patients with relapsed/refractory AL Amyloidosis[19,21,27] - In the NEXICART-2 U S trial, 70% complete responses (CR) were observed in 7 out of 10 patients, with the remaining three being MRD-negative 10-6, predicting future CR[49] NXC-201 Safety and Tolerability - NXC-201 demonstrated no ICANS neurotoxicity in clinical trials[54] - NXC-201 has a median CRS duration of 1 day, which is 4-8x shorter than other CAR-T therapies[32]

Immix Biopharma, Inc. (IMMX) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.The power of a changin ...

Core Points - Immix Biopharma, Inc. was selected to attend an FDA CEO forum led by FDA Commissioner Marty A. Makary on June 5, 2025, focusing on modernizing the regulatory framework for biotechnology and pharmaceutical industries [1][2] - The forum aimed to gather input from industry leaders to enhance patient access to safe and effective therapies, with Immix Biopharma expressing alignment with the FDA's vision for an efficient regulatory environment [2] - Immix Biopharma is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis, with its lead candidate being NXC-201, a BCMA-targeted CAR-T cell therapy currently in a multi-center study [3] Company Overview - Immix Biopharma, Inc. (Nasdaq: IMMX) is focused on developing cell therapies for serious diseases, particularly AL Amyloidosis [3] - The lead candidate, NXC-201, is being evaluated in the NEXICART-2 study (NCT06097832) for relapsed/refractory AL Amyloidosis, with interim results presented at ASCO 2025 [3] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation (ODD) from the FDA and EMA [3]

Immix Biopharma (IMMX) Update / Briefing June 03, 2025 03:00 PM ET Speaker0 Thank you for joining us for this Key opinion leader event following ASCO twenty twenty five oral presentation of NXC two zero one Nexicar two trial interim results in relapsedrefractory AL amyloidosis that's just concluded. Here's the requisite disclaimers. And here's the agenda for today's event. First part will be led by doctor Raza who who'll share the unmet clinical need in relapsedrefractory AL amyloidosis and current treatmen ...

Core Insights - Immix Biopharma's NXC-201 achieved a complete response (CR) rate of 70% in the NEXICART-2 Phase 1/2 clinical trial for relapsed/refractory AL Amyloidosis, meeting its primary endpoint [1][4][3] - The trial reported no relapses or safety signals to date, indicating a favorable safety profile for NXC-201 [1][4] - Immix plans to submit a Biologics License Application (BLA) to the FDA for NXC-201 following these promising results [1][3] Clinical Trial Details - The NEXICART-2 trial is a U.S. multi-site, single-arm study evaluating NXC-201 in patients with relapsed/refractory AL Amyloidosis, with a data cutoff of April 11, 2025 [1][3][7] - Prior to treatment, patients had a median of 4 lines of therapy, and all had organ involvement from the disease [4] - After treatment, all patients normalized pathological disease markers, with 70% achieving complete responses [4] Safety and Efficacy - No neurotoxicity was observed, and only low-grade cytokine release syndrome was reported [4][9] - The remaining 3 patients who did not achieve CR are minimum residual disease (MRD) negative, suggesting potential future CRs [4] Market Context - Current treatments for relapsed/refractory AL Amyloidosis have a CR rate of less than 10%, highlighting a significant unmet medical need [5] - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients by 2024 [11] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [11] Company Overview - Immix Biopharma is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [12] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation from both the FDA and EMA [9][12]

Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [7] - The lead candidate is NXC-201, a sterically-optimized BCMA-targeted CAR-T cell therapy, currently being evaluated in the NEXICART-2 study [4][7] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation (ODD) from both the FDA and EMA [4][7] Clinical Trial Updates - The NEXICART-2 clinical trial is actively enrolling patients, with 14 U.S. sites currently participating, an increase of 10 sites since the last update [1][2] - The company anticipates completing the NEXICART-2 clinical trial ahead of schedule due to robust enrollment and demand [2] - The trial aims to enroll 40 patients with preserved heart function who have not previously received BCMA-targeted therapy, focusing on safety and efficacy as primary endpoints [3] Market Insights - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% annually, reaching approximately 33,277 patients by 2024 [6] - The AL Amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [6] Upcoming Presentations - Phase 1/2 interim readout data from the NEXICART-2 trial will be presented at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago from May 30 to June 3, 2025 [2]

Core Insights - Immix Biopharma reported strong efficacy and favorable safety results for its NXC-201 therapy in the NEXICART-2 Phase 1/2 clinical trial for relapsed/refractory AL Amyloidosis, with a complete response (CR) rate of 71% [1][4][3] - The company has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for NXC-201, indicating significant progress towards regulatory approval [3][9] - The upcoming ASCO presentation on June 3, 2025, will provide updated results and further analysis of the trial data [5][2] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [12] - The lead candidate, NXC-201, is a BCMA-targeted CAR-T cell therapy that has shown promising results in initial studies [9][12] - The company aims to enroll 40 patients in the ongoing NEXICART-2 trial, which is designed to evaluate the safety and efficacy of NXC-201 [8] Clinical Trial Details - The NEXICART-2 trial is a U.S. multi-site, single-arm study assessing NXC-201 in patients with relapsed/refractory AL Amyloidosis [8] - Prior to treatment, patients had a median of 4 lines of therapy, and all had organ involvement due to the disease [4] - No relapses or significant safety signals have been reported to date, with only low-grade cytokine release syndrome observed [4][3] Market Context - The prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients in 2024 [11] - The AL Amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [11]

Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [12] - The lead candidate is NXC-201, a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy [12] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation (ODD) from both the FDA and EMA [9][12] Clinical Trials - The ongoing NEXICART-2 trial (NCT06097832) is a single-arm multi-site Phase 1/2 clinical trial evaluating NXC-201 in patients with relapsed/refractory AL Amyloidosis [8] - The trial aims to enroll 40 patients with preserved heart function and has safety as the primary endpoint for Phase 1 and efficacy for Phase 2 [8] - Initial data from the ex-U.S. study NEXICART-1 has shown high complete response rates in relapsed/refractory AL Amyloidosis [9] Market Insights - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients by 2024 [11] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [11] Key Opinion Leaders - A virtual KOL event is scheduled for June 3, 2025, featuring experts discussing interim clinical data from the NEXICART-2 trial [1][2] - Notable speakers include Dr. Heather Landau, Dr. Shahzad Raza, and Dr. Jeffrey Zonder, who will share their clinical experiences with NXC-201 [2][4][6][7]