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) reported its 2021 Q2 financial results, highlighting progress in CAR-T therapy cilta-cel, with FDA and EMA applications accepted. Key results include:
- Q2 revenue of $20.2 million, a 74% increase year-over-year.
- Clinical trial data shows an 81% overall survival rate in relapsed/refractory multiple myeloma patients.
- Net loss decreased to $91.6 million ($0.33 per share) from $134.9 million ($0.63 per share) in Q2 2020.
The company anticipates significant advancements in the second half of 2021.
Legend Biotech (NASDAQ: LEGN) announced the establishment of a new manufacturing facility in Belgium, a joint venture with Janssen Pharmaceutica NV, to enhance global production of cell therapies. This facility will support the commercialization of cilta-cel, an investigational CAR-T therapy for multiple myeloma, currently under regulatory review in several regions, including the U.S. and Europe. The Belgium site aims to be operational by 2023, adding to existing facilities in China and the U.S., positioning Legend to leverage Belgium's talent and life sciences ecosystem.
Legend Biotech Corporation (NASDAQ: LEGN) announced new results for its investigational CAR-T therapy, ciltacabtagene autoleucel (cilta-cel), at the 2021 ASCO Annual Meeting and EHA Virtual Congress. In the CARTITUDE-1 study involving 97 patients with relapsed or refractory multiple myeloma, an overall response rate of 98% was reported, with 81% overall survival at 18 months. The therapy has shown manageable safety profiles, with prevalent adverse events being hematologic. A Biologics License Application for cilta-cel has been accepted by the FDA with a target action date of November 29, 2021.
Legend Biotech Corporation (NASDAQ: LEGN) announced that the FDA has accepted the Biologics License Application for cilta-cel, a CAR-T therapy aimed at treating relapsed or refractory multiple myeloma, under priority review. The PDUFA target action date is set for November 29, 2021. Cilta-cel has previously received Breakthrough Therapy Designation, indicating significant potential benefits for patients. Ying Huang, CEO, emphasized the importance of this milestone as the company collaborates with Janssen Biotech to expedite this innovative treatment.
Legend Biotech Corporation (NASDAQ: LEGN) has announced its participation in the Jefferies Virtual Healthcare Conference on June 3, 2021, at 9:30 am ET. Interested parties can access the webcast via the Legend Biotech website. This clinical-stage biopharmaceutical company focuses on developing novel cell therapies, particularly its lead candidate, cilta-cel, an investigational CAR-T therapy aimed at multiple myeloma patients. With over 800 employees globally, Legend Biotech is positioned to advance best-in-class cell therapies for oncology.
Legend Biotech Corporation (NASDAQ: LEGN) reported its Q1 2021 financial results, showing revenue of $13.7 million, up from $11.5 million in Q1 2020, largely due to milestone payments from Janssen. R&D expenses surged to $71.1 million, reflecting increased clinical trials. The net loss widened to $80.9 million, or $0.30 per share, compared to $44.2 million, or $0.22 per share in the prior year. Key milestones include the completion of the BLA and MAA for cilta-cel, aiming for approvals for multiple myeloma treatment. Cash and equivalents stood at approximately $412.3 million.
Legend Biotech (NASDAQ: LEGN) announced the acceptance of 15 abstracts for the upcoming 2021 ASCO and EHA meetings, featuring new data from the CARTITUDE clinical program for its CAR-T therapy, cilta-cel. Key presentations include updated efficacy and safety results from the CARTITUDE-1 study for relapsed/refractory multiple myeloma. The findings support regulatory filings by Legend's collaborator, Janssen. The company emphasizes its commitment to innovative treatments that aim to improve patient outcomes in multiple myeloma.
Legend Biotech Corporation (NASDAQ: LEGN) has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency for the approval of ciltacabtagene autoleucel (cilta-cel) as a treatment for relapsed and/or refractory multiple myeloma. This investigational CAR-T therapy is supported by positive results from the CARTITUDE-1 study, presented at the ASH 2020 Annual Meeting. The EMA granted accelerated assessment for the MAA, highlighting its public health significance. A Biologics License Application is also under review by the FDA.
Legend Biotech Corporation (NASDAQ: LEGN) reported its financial results for the year ending December 31, 2020, highlighting a revenue of $75.7 million, up from $57.3 million in 2019. Notably, the fourth quarter revenue increased to $40.8 million, primarily due to milestone payments from Janssen Biotech. However, the net loss for 2020 rose to $303.5 million, or $1.28 per share, compared to $133 million, or $0.66 per share, in 2019. The company anticipates significant milestones in its oncology pipeline, particularly for cilta-cel, amidst ongoing challenges from the COVID-19 pandemic.
Legend Biotech Corporation (NASDAQ: LEGN) will announce its fourth quarter and full-year 2020 financial results on March 18, 2021, before U.S. markets open. A conference call will follow at 8:00 am ET, accessible via telephone and webcast. The company focuses on developing novel cell therapies for oncology, particularly its lead product candidate, ciltacabtagene autoleucel, aimed at treating multiple myeloma. This investigational therapy is in registrational clinical trials, highlighting Legend Biotech's commitment to advancing innovative cancer treatments.
