Legend Biotech Corporation American Depositary Shares - LEGN STOCK NEWS

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.

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 39^th 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.