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 Corp (NASDAQ: LEGN) is a clinical-stage biopharmaceutical leader in developing CAR-T cell therapies for oncology, including multiple myeloma. This page serves as the definitive resource for tracking LEGN's corporate developments, research breakthroughs, and regulatory milestones.
Investors and industry professionals will find timely updates on clinical trial results, partnership announcements, and strategic initiatives driving innovation in cell therapy. The curated news collection provides transparent access to primary source materials while maintaining compliance with financial disclosure standards.
Key content categories include clinical trial updates, regulatory filings, research collaborations, and business development activities. Each news item is verified for accuracy and relevance to support informed decision-making.
Bookmark this page for direct access to Legend Biotech's official communications and expert analyses of their pioneering work in cancer immunotherapy. Regularly updated to reflect the latest advancements in CAR-T technology and oncology treatment development.
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.
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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.
Legend Biotech Corporation (NASDAQ: LEGN) announced its participation in the 19th Annual Morgan Stanley Virtual Global Healthcare Conference on September 10. CEO and CFO Ying Huang will represent the company at 8:45 a.m. Eastern Time. Investors can access the conference webcast on the Legend Biotech website. The company focuses on developing novel cell therapies for oncology, notably its lead candidate cilta-cel for multiple myeloma, currently in registrational clinical trials. With over 900 employees across the U.S., China, and Europe, Legend Biotech is poised to advance innovative treatments.
