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 (NASDAQ: LEGN) generates frequent news as a global cell therapy company focused on CAR‑T treatments for cancer. News coverage for Legend Biotech often centers on CARVYKTI® (ciltacabtagene autoleucel; cilta‑cel), its BCMA‑targeted CAR‑T cell therapy for relapsed or refractory multiple myeloma, as well as updates on its broader pipeline of cell therapy programs.
Investors and observers following LEGN news can expect regular announcements on clinical data from the CARTITUDE program in multiple myeloma, including long‑term progression‑free survival results and analyses of earlier‑line use. Company press releases also highlight presentations at major medical meetings such as the American Society of Hematology (ASH), the American Society of Clinical Oncology (ASCO), and the European Hematology Association (EHA), where Legend Biotech shares outcomes from CARVYKTI and investigational candidates like LUCAR‑G39D, LB2102, and LB1908.
Legend Biotech’s news flow includes regulatory milestones, such as FDA and European Commission label updates for CARVYKTI to incorporate overall survival data and new safety information. The company also reports on manufacturing and infrastructure developments, including expansion of its Raritan, New Jersey cell therapy facility and commercial production in Ghent, Belgium, which are intended to support growing global demand.
Quarterly earnings releases and related Form 6‑K filings provide financial updates on collaboration revenue from CARVYKTI, license revenue from agreements with partners, operating expenses, cash and time deposits, and progress toward profitability. Corporate news items may also cover executive appointments, participation in investor conferences, and strategic priorities outlined at healthcare investment events.
For users tracking LEGN, this news page offers a centralized view of Legend Biotech’s clinical, regulatory, manufacturing, and financial announcements, helping contextualize the company’s evolution in the cell therapy and oncology landscape.
Legend Biotech announces that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended the marketing authorization of CARVYKTI™ (ciltacabtagene autoleucel) for treating adults with relapsed and refractory multiple myeloma. This recommendation is pivotal for Legend Biotech as it hopes to gain EC approval, marking the company’s first EC-approved product. The therapy, developed in collaboration with Janssen Pharmaceutica, has shown promising results in the ongoing CARTITUDE-1 study. The FDA previously approved cilta-cel on February 28, 2022.
Janssen Pharmaceutical Companies announced a positive recommendation from the European Medicines Agency's CHMP for cilta-cel, a CAR-T therapy targeting relapsed and refractory multiple myeloma in adults with prior therapy failures. Cilta-cel, developed in collaboration with Legend Biotech, is supported by pivotal CARTITUDE-1 study data and aims to provide new treatment options for this challenging disease. The therapy received FDA approval in February 2022 and addresses an urgent need in multiple myeloma treatment.
Legend Biotech Corporation (NASDAQ: LEGN) has been awarded the Newcomer of the Year at the Foreign Investment Trophy ceremony by Flanders Investment & Trade in Belgium. The company received this recognition for its substantial investment in a cutting-edge manufacturing facility in Flanders, a collaboration with Janssen Pharmaceutica N.V. This facility will be the first dedicated cell therapy manufacturing site in the region and is designed to produce cilta-cel, a CAR-T therapy for multiple myeloma. The site is projected to be operational in 2023.
Legend Biotech announced the FDA approval of CARVYKTI™ (ciltacabtagene autoleucel) for treating adults with relapsed/refractory multiple myeloma after four prior therapies. The company reported unaudited Q4 2021 financial results, showing a revenue decrease to $39 million from $40.8 million in Q4 2020, while annual revenue rose to $89.8 million from $75.7 million. R&D expenses increased by 29% in Q4 and 35% for 2021, totaling $313.3 million. Net losses for Q4 and the full year were $88.3 million and $386.2 million, respectively, reflecting ongoing commercialization efforts.
Rocket Pharmaceuticals (NASDAQ: RCKT) has appointed Jessie Yeung as Vice President of Investor Relations and Corporate Finance. With over 15 years of experience, including a previous role at Legend Biotech (NASDAQ: LEGN), Yeung will lead investor relations and capital market strategies. CEO Gaurav Shah emphasized Yeung's expertise will enhance communication with investors as the company approaches significant milestones in gene therapy clinical programs.
Legend Biotech has received FDA approval for its first product, CARVYKTI™ (ciltacabtagene autoleucel), targeting adults with relapsed or refractory multiple myeloma who previously underwent four or more lines of therapy. Based on the pivotal CARTITUDE-1 study, CARVYKTI™ demonstrated a high overall response rate of 98%, with 78% achieving stringent complete response. The product will be available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). CEO Ying Huang considers this approval a significant milestone for the company, expected to fulfill an unmet need in the treatment of multiple myeloma.
Legend Biotech (NASDAQ: LEGN) announced preliminary, unaudited financial results for the year ended December 31, 2021. The company expects a loss of approximately US$365.3M to US$397.4M, with R&D expenses between US$297.9M and US$321.8M primarily due to investments in its lead candidate, cilta-cel. Additionally, a non-cash fair value loss of US$5.7M to US$6.4M is anticipated related to warrant liability changes. As of December 31, 2021, Legend Biotech reported around US$688.9M in cash and cash equivalents, emphasizing its financial stability despite significant expected losses.
Legend Biotech Corporation (NASDAQ: LEGN) announced that its Phase 1 clinical trial for LB1901, an investigational CAR-T therapy for relapsed T-cell lymphoma, has been placed on clinical hold by the U.S. FDA. This decision follows the company’s prior voluntary pause due to low CD4+ T-cell counts in the trial patient. Although the patient has not experienced any serious adverse events, the FDA will issue an official clinical hold letter by March 11, 2022. The company is committed to monitoring the patient while addressing the FDA's concerns.
Legend Biotech Corporation (NASDAQ: LEGN) has secured $50 million in milestone payments under its collaboration with Janssen Biotech for ciltacabtagene autoleucel (cilta-cel), a CAR-T therapy for multiple myeloma. The agreement, which grants Legend a 50-50 cost and profit share globally (70-30 in Greater China), has resulted in $250 million in total milestone payments so far. Cilta-cel, designated as a Breakthrough Therapy and Orphan Drug, is under regulatory review by the FDA and EMA for treating relapsed or refractory multiple myeloma.
iECURE has expanded its management team by appointing Mark Semanick as Vice President and Head of Technical Operations, effective January 31, 2022, and Brad Dickerson as Vice President of Project Management & Patient Advocacy, effective February 14, 2022. Both executives bring extensive experience in the biotech industry, particularly in rare diseases and gene therapies. CEO Joseph Truitt emphasized their importance in preparing for clinical trials and enhancing manufacturing capabilities as the company advances its gene editing therapies for monogenic liver disorders.