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.
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.
Legend Biotech Corporation (NASDAQ: LEGN) announced preliminary financial results for the year ended December 31, 2020, projecting a loss of approximately US$292.2 million to US$324.9 million, with an adjusted loss of US$202.4 million to US$234.4 million. The losses primarily stem from substantial R&D expenses totaling US$220.7 million to US$255.6 million linked to its lead product candidate, cilta-cel. Additionally, a one-time non-cash fair value loss of about US$80 million was reported due to the conversion of Series A preferred shares. As of year-end, the company held roughly US$455.7 million in cash and equivalents.
Legend Biotech Corporation (NASDAQ: LEGN) has commenced the submission of a Biologics License Application (BLA) to the FDA for cilta-cel, a CAR-T therapy aimed at treating relapsed or refractory multiple myeloma. This initiative is rooted in the pivotal CARTITUDE-1 study, which demonstrated significant efficacy and safety. The collaboration with Janssen has also resulted in a $75M milestone payment due to the progress of cilta-cel. The FDA's previous Breakthrough Therapy Designation for cilta-cel underlines its potential impact in addressing unmet medical needs.
Legend Biotech Corporation (NASDAQ: LEGN) will participate virtually in the 39th Annual J.P. Morgan Healthcare Conference on January 11, 2021. CEO Ying Huang will provide updates on January 13, 2021, at 4:30 PM ET. The event will be accessible via a webcast available on their website. Legend Biotech focuses on developing novel cell therapies, particularly its lead candidate, ciltacabtagene autoleucel, targeting multiple myeloma, currently in registrational trials. The company employs over 800 staff across the globe.
Legend Biotech Corporation (NASDAQ: LEGN) has been added to the NASDAQ Biotechnology Index, effective December 21, 2020. This addition is part of the annual re-ranking, where 100 biotech stocks were included, while 16 were removed. The NASDAQ Biotechnology Index tracks biotechnology and pharmaceutical securities listed on NASDAQ, calculated using a modified capitalization-weighted methodology. Legend Biotech focuses on novel cell therapies for oncology, notably its lead candidate, ciltacabtagene autoleucel, for multiple myeloma, currently in registrational clinical trials.
Legend Biotech (NASDAQ: LEGN) has received FDA clearance for its Investigational New Drug (IND) application to evaluate LB1901, an autologous CAR-T therapy targeting relapsed or refractory T-cell lymphoma (TCL). This clearance allows the company to initiate a Phase 1 clinical study in the U.S., focusing on safety, tolerability, and the recommended Phase 2 dose. TCL represents a significant unmet medical need, with PTCL and CTCL often leading to poor survival rates. CEO Ying Huang emphasized the importance of this milestone for the company’s innovation in cell therapy.
Legend Biotech Corporation (NASDAQ: LEGN) announced encouraging results from the Phase 1b/2 CARTITUDE-1 study of ciltacabtagene autoleucel (cilta-cel) for relapsed or refractory multiple myeloma. With a median follow-up of 12.4 months, the overall response rate (ORR) reached 97%, with 67% achieving stringent complete response. The study included 97 patients with a history of extensive prior therapies. Safety data indicated manageable adverse events, with most being Grade 1/2. The findings suggest cilta-cel could be a transformative option for patients in need.