Los Angeles, CA, Oct. 06, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), the global leader in relapsed/refractory AL Amyloidosis, today announced that it will present a NXC-201 abstract at the upcoming American Society of Hematology (ASH) 67th Annual Meeting and Exposition to be held December 6-9, 2025, in Orlando, Florida. About AL AmyloidosisAL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that b ...

– On track for first FDA Biologics License Application (BLA) approved cell therapy in orphan indication relapsed/refractory AL Amyloidosis – Los Angeles, CA, Sept. 18, 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 50% enrollment milestone has already been surpassed in NEXICART-2, its relapsed/refractory AL Amyloidosis clini ...

Company Overview - Legend Biotech Corporation is a global leader in cell therapy with over 2,800 employees, making it the largest standalone cell therapy company [3] - The company is pioneering treatments that aim to transform cancer care, particularly through its CAR-T cell therapy [3] - CARVYKTI, a one-time treatment for relapsed or refractory multiple myeloma, is developed and marketed in collaboration with Johnson & Johnson [3] Upcoming Events - Ying Huang, Ph.D., the CEO of Legend Biotech, will participate in a fireside chat at the Morgan Stanley Global Healthcare Conference on September 9, 2025, at 4:05 p.m. ET [1] - The live webcast of the event will be accessible through the Investor Relations section of Legend's website, with a replay available approximately 48 hours after the event [2]

Core Viewpoint - Legend Biotech Corporation has appointed Carlos Santos as the new Chief Financial Officer, effective immediately, succeeding Jessie Yeung who served as interim CFO since January 2025 [1][2][3] Group 1: Leadership Changes - Carlos Santos brings extensive experience in financial operations across various regions including the US, Latin America, Europe, the Middle East, and Africa [2] - Santos previously held the position of CFO for US Oncology at AstraZeneca and has a decade-long tenure there, along with roles at Alcon and Intel Corporation [3][4] - The CEO of Legend Biotech, Ying Huang, expressed confidence in Santos's financial expertise to drive the success of the company's CAR-T cell therapy franchise, CARVYKTI, and achieve profitability by 2026 [3] Group 2: Company Overview - Legend Biotech is a leading company in cell therapy with over 2,800 employees and is recognized for its innovative CAR-T cell therapy, CARVYKTI, which targets relapsed or refractory multiple myeloma [5] - The company collaborates with Johnson & Johnson for the development and marketing of CARVYKTI and aims to expand patient access and therapeutic potential [5] - Legend Biotech is focused on building a comprehensive cell therapy company and driving future innovations across its pipeline [5]

Core Insights - Legend Biotech Corporation reported strong second quarter 2025 financial results, highlighting the success of CARVYKTI in treating relapsed and refractory multiple myeloma, with one-third of patients remaining progression-free for five years [2][6][10]. Financial Performance - CARVYKTI net trade sales reached approximately $439 million in Q2 2025, marking the strongest single period of sales for any CAR-T therapeutic to date [6][11]. - Total revenue for the three months ended June 30, 2025, was $255.1 million, compared to $186.5 million for the same period in 2024, reflecting a significant increase [15]. - Collaboration revenue increased to $219.7 million in Q2 2025 from $93.3 million in Q2 2024, driven by CARVYKTI sales [11][15]. - License revenue decreased to $35.3 million in Q2 2025 from $90.8 million in Q2 2024, primarily due to the timing of milestone achievements [11][15]. - Adjusted net income for Q2 2025 was $10.1 million, compared to an adjusted net loss of $2.5 million in Q2 2024 [11][26]. Regulatory Developments - The FDA removed Risk Evaluation and Mitigation Strategies (REMS) for CARVYKTI and updated product labeling to reduce certain monitoring requirements for patients [3]. Clinical Advancements - Over 7,500 patients have been treated with CARVYKTI to date, with positive long-term outcomes presented at the 2025 ASCO Annual Meeting [6][7]. - The CARTITUDE-1 study demonstrated that one-third of patients remained progression-free for five years, reinforcing the therapy's durability [2][6]. - New data from the Phase 3 CARTITUDE-4 study and preliminary results from LB2102 and LB1908 studies were also presented, showcasing ongoing innovation in the company's pipeline [7]. Cash Position - As of June 30, 2025, the company reported cash and cash equivalents of $1.0 billion, providing a financial runway into 2026 [6][11].

Company Overview - Legend Biotech Corporation is a global leader in cell therapy with over 2,600 employees, making it the largest standalone cell therapy company [3] - The company is pioneering treatments that aim to revolutionize cancer care, particularly through its CAR-T cell therapy, CARVYKTI, which is a one-time treatment for relapsed or refractory multiple myeloma [3] - Legend Biotech collaborates with Johnson & Johnson for the development and marketing of CARVYKTI and is focused on maximizing patient access and therapeutic potential [3] Upcoming Events - Legend Biotech will host a conference call for investors on August 11, 2025, at 8:00 am ET to review its second-quarter 2025 results [1] - Senior leaders will provide an overview of the company's performance during the quarter [1] - A replay of the webcast and earnings news release will be available approximately two hours after the call concludes [2]

Company Overview - Arcellx, Inc. (NASDAQ: ACLX) is advancing its lead CAR-T cell therapy, anitocabtagene Autoleucel (anito-cel), aimed at treating patients with relapsed/refractory multiple myeloma (r/r MM) [2] Industry Insights - The article highlights the importance of deep-dive analysis in the pharmaceutical sector, particularly for investors interested in biotech companies [2]

Core Insights - Anixa Biosciences has initiated dosing for the first patient in the fourth dosage cohort of its Phase 1 clinical trial for CAR-T therapy targeting recurrent ovarian cancer, marking a significant advancement in the study [1][2] - The fourth cohort will receive a dose of three million CAR-positive cells per kilogram, which is thirty times higher than the initial cohort dose, indicating a strategic escalation in dosage to assess safety and efficacy [2][4] Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a specific emphasis on ovarian cancer immunotherapy developed in collaboration with Moffitt Cancer Center [4] - The company's CAR-T technology targets the follicle-stimulating hormone receptor (FSHR), which is exclusively expressed on ovarian cells and certain cancer cells, positioning it uniquely in the oncology landscape [3][4] - Anixa's business model involves partnerships with leading research institutions, allowing for the exploration of emerging technologies in cancer treatment [4]

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]

Core Insights - Legend Biotech Corporation announced long-term results from the CARTITUDE-1 study, showing that 33% of heavily pretreated relapsed/refractory multiple myeloma patients remained progression-free for five years after a single infusion of CARVYKTI [1][4][6] Group 1: Study Results - In the CARTITUDE-1 study, at a median follow-up of 61.3 months, patients treated with CARVYKTI demonstrated a median overall survival (OS) of 60.7 months [4] - Among 97 patients, 32 (33%) remained progression-free for five years or more without further myeloma treatment [4][6] - A subset analysis of 12 patients who underwent minimal residual disease assessments showed all remained progression-free and MRD-negative for five years [3] Group 2: Safety and Efficacy - Safety signals were consistent with the known profile of CARVYKTI, with no new movement or neurocognitive treatment-emergent adverse events reported [5] - Two new cases of second primary malignancies were reported, both solid tumors [5] - The CARTITUDE-4 study indicated that CARVYKTI improved progression-free survival (PFS) and overall survival (OS) compared to standard therapies in high-risk subgroups [7][9] Group 3: Future Developments - Ongoing Phase 1 studies of LB1908 and LB2102 in gastroesophageal and lung cancers, respectively, show promising early results, indicating potential for next-generation cell therapies [8][11] - Legend Biotech entered an exclusive global license agreement with Novartis for certain CAR-T cell therapies targeting DLL3, including LB2102 [15][17]