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 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.
Legend Biotech Corporation (NASDAQ: LEGN) has appointed Dr. Patrick Casey as an independent director to its Board of Directors. Dr. Casey's extensive expertise in scientific research, particularly in pharmacology and cancer biology, is seen as a significant addition to the board. His role is expected to bolster Legend Biotech's efforts in developing innovative cell therapies, particularly its lead product candidate, ciltacabtagene autoleucel, aimed at treating multiple myeloma. The appointment reflects the company's commitment to its pipeline development strategy.
Legend Biotech Corporation (NASDAQ: LEGN) is set to host a virtual Key Opinion Leader (KOL) event on December 7 at 7 pm ET. This event will showcase the latest data from the CARTITUDE-1 study (NCT03548207), focusing on ciltacabtagene autoleucel (cilta-cel), a CAR-T cell therapy for relapsed or refractory multiple myeloma. Presentations will include insights from experts in hematology and oncology, including Ying Huang, CEO, and leading medical professionals. Register and access the webcast at LegendBiotechASH2020.Convene.com.
Legend Biotech Corporation (NASDAQ: LEGN) announced the appointment of Dr. Li Zhu to its Board of Directors as a Class III director. Dr. Zhu's experience includes key roles at GenScript Biotech and Clontech Laboratories, enhancing the Board's strategic capabilities. Concurrently, Dr. Fangliang Zhang resigned effective November 22, 2020, due to ongoing legal issues in China, although no charges have been filed against him or Legend Biotech. The Board expressed gratitude for Dr. Zhang's contributions, while the company focuses on advancing its lead product candidate, ciltacabtagene autoleucel, for multiple myeloma.