Welcome to our dedicated page for Legend Biotech news (Ticker: LEGN), a resource for investors and traders seeking the latest updates and insights on Legend Biotech stock.
Legend Biotech Corporation reports news on cell therapy development and commercialization, centered on CARVYKTI® (ciltacabtagene autoleucel), a CAR-T therapy for relapsed or refractory multiple myeloma developed and marketed with Johnson & Johnson. Company updates commonly cover CARVYKTI sales trends, treatment-site expansion, manufacturing capacity, clinical and real-world data from the CARTITUDE program, and label or evidence developments tied to multiple myeloma care.
Legend Biotech news also follows its broader cell therapy pipeline, including allogeneic and in vivo CAR-T programs such as LUCAR-G39D in B-cell non-Hodgkin lymphoma. Recurring announcements include quarterly financial results, scientific-conference presentations, research and manufacturing priorities, advisory input, and corporate governance updates.
Janssen Pharmaceutical Companies of Johnson & Johnson announced promising long-term results from the Phase 1b/2 CARTITUDE-1 study of ciltacabtagene autoleucel (cilta-cel) for relapsed/refractory multiple myeloma. At a median follow-up of 22 months, 83% of patients achieved a stringent complete response, while 92% of evaluable patients achieved minimal residual disease negativity. Median progression-free survival and overall survival were not reached, with two-year rates of 61% and 74%, respectively. The safety profile remained consistent, and no new safety signals were observed.
GenScript ProBio has inaugurated China's largest GMP plasmid manufacturing facility in Zhenjiang, Jiangsu Province, enhancing its service offerings for plasmids used in cell and gene therapy. The 6,400-square-meter plant significantly increases production capacity and positions the company as a leading Contract Development and Manufacturing Organization (CDMO). It provides comprehensive plasmid services from preclinical studies to commercial manufacturing, supporting mRNA vaccine development and clinical trial approvals globally, including in China and South Korea.
Legend Biotech Corporation (NASDAQ: LEGN) announced the submission of a New Drug Application (NDA) for its CAR-T cell therapy, ciltacabtagene autoleucel (cilta-cel), to Japan's Ministry of Health. This submission is based on pivotal data from the CARTITUDE-1 study targeting adults with relapsed or refractory multiple myeloma. Cilta-cel has received several designations, including Breakthrough Therapy Designation. The ongoing international regulatory review underscores its potential to address significant treatment gaps for patients with limited options.
Legend Biotech Corporation (NASDAQ: LEGN) will host a hybrid event on Monday, December 13 at 8pm ET, featuring key opinion leaders in multiple myeloma. The meeting will present new data from the CARTITUDE Clinical Development Program focused on ciltacabtagene autoleucel (cilta-cel), an investigational CAR-T therapy for patients with relapsed/refractory multiple myeloma. This presentation follows the studies at the 63rd ASH Annual Meeting. Interested parties can access the event on the Legend Biotech website.
Legend Biotech Corporation (NASDAQ: LEGN) has submitted a New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel) to the Japanese Ministry of Health, Labour and Welfare. This investigational CAR-T cell therapy targets B-cell maturation antigen (BCMA) for adults with relapsed or refractory multiple myeloma who have undergone at least three prior therapies. The NDA is based on the CARTITUDE-1 study results, and cilta-cel is under review by various global health authorities, including in the U.S. and Europe.
Legend Biotech reported its Q3 2021 financial results, showcasing a revenue increase to $16.9 million, up from $11.7 million in Q3 2020. Key developments include the completion of enrollment in the Phase 3 CARTITUDE-4 study for cilta-cel in multiple myeloma and the initiation of a Phase 1 trial for LB1901 targeting T-cell lymphoma. Despite these advancements, the company faced a net loss of $124.8 million for the quarter. The FDA extended the cilta-cel PDUFA target date to February 28, 2022, allowing additional review time. Upcoming data presentations are scheduled for the ASH Annual Meeting.
Legend Biotech Corporation (NASDAQ: LEGN) announced the acceptance of 12 studies for presentation at the 63rd American Society of Hematology Annual Meeting. Highlights include data from the CARTITUDE-1 study, which focuses on cilta-cel for treating relapsed/refractory multiple myeloma, showcasing its efficacy in high-risk patients. The first data from CARTITUDE-2 will also be revealed, along with promising preclinical results for the tri-specific VHH CAR-T (LCAR-AIO) therapy targeting B-cell malignancies. Key presentations will occur from December 11-14, 2021.
Legend Biotech Corporation announced an extension of the Prescription Drug User Fee Act (PDUFA) target date for its investigational CAR-T therapy, ciltacabtagene autoleucel (cilta-cel), to February 28, 2022. This decision by the FDA was made to review updated analytical methods submitted by Janssen Biotech, with whom Legend collaborates. The CEO expressed confidence in cilta-cel's potential for patients with relapsed and refractory multiple myeloma. Notably, no additional clinical data have been requested by the FDA.
Legend Biotech Corporation (NASDAQ: LEGN) will host its first Research & Development Day on October 18, starting at 10:00 a.m. (Eastern Time), at Andaz 5th Avenue, New York. The event will showcase updates on their advancing pipeline for hematological and oncological indications, including their BCMA clinical development program. Presentations will be made by senior leaders, including CEO Ying Huang and CSO Frank Fan. A live webcast will be available on the Legend Biotech website, with recordings accessible for six months.
Legend Biotech Corporation (NASDAQ: LEGN) has initiated a Phase 1 clinical trial for LB1901, an autologous CAR-T therapy targeting CD4 for adults with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL). The trial follows FDA approval of the Investigational New Drug (IND) application and is led by Dr. Swaminathan P. Iyer at The University of Texas MD Anderson Cancer Center. This open-label, multi-center study aims to assess the safety and optimal dosing of LB1901 for patients with unmet medical needs in these serious conditions.