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 Corporation (NASDAQ: LEGN) has submitted a New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel) to the Japanese Ministry of Health, Labour and Welfare. This investigational CAR-T cell therapy targets B-cell maturation antigen (BCMA) for adults with relapsed or refractory multiple myeloma who have undergone at least three prior therapies. The NDA is based on the CARTITUDE-1 study results, and cilta-cel is under review by various global health authorities, including in the U.S. and Europe.
Legend Biotech reported its Q3 2021 financial results, showcasing a revenue increase to $16.9 million, up from $11.7 million in Q3 2020. Key developments include the completion of enrollment in the Phase 3 CARTITUDE-4 study for cilta-cel in multiple myeloma and the initiation of a Phase 1 trial for LB1901 targeting T-cell lymphoma. Despite these advancements, the company faced a net loss of $124.8 million for the quarter. The FDA extended the cilta-cel PDUFA target date to February 28, 2022, allowing additional review time. Upcoming data presentations are scheduled for the ASH Annual Meeting.
Legend Biotech Corporation (NASDAQ: LEGN) announced the acceptance of 12 studies for presentation at the 63rd American Society of Hematology Annual Meeting. Highlights include data from the CARTITUDE-1 study, which focuses on cilta-cel for treating relapsed/refractory multiple myeloma, showcasing its efficacy in high-risk patients. The first data from CARTITUDE-2 will also be revealed, along with promising preclinical results for the tri-specific VHH CAR-T (LCAR-AIO) therapy targeting B-cell malignancies. Key presentations will occur from December 11-14, 2021.
Legend Biotech Corporation announced an extension of the Prescription Drug User Fee Act (PDUFA) target date for its investigational CAR-T therapy, ciltacabtagene autoleucel (cilta-cel), to February 28, 2022. This decision by the FDA was made to review updated analytical methods submitted by Janssen Biotech, with whom Legend collaborates. The CEO expressed confidence in cilta-cel's potential for patients with relapsed and refractory multiple myeloma. Notably, no additional clinical data have been requested by the FDA.
Legend Biotech Corporation (NASDAQ: LEGN) will host its first Research & Development Day on October 18, starting at 10:00 a.m. (Eastern Time), at Andaz 5th Avenue, New York. The event will showcase updates on their advancing pipeline for hematological and oncological indications, including their BCMA clinical development program. Presentations will be made by senior leaders, including CEO Ying Huang and CSO Frank Fan. A live webcast will be available on the Legend Biotech website, with recordings accessible for six months.
Legend Biotech Corporation (NASDAQ: LEGN) has initiated a Phase 1 clinical trial for LB1901, an autologous CAR-T therapy targeting CD4 for adults with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL). The trial follows FDA approval of the Investigational New Drug (IND) application and is led by Dr. Swaminathan P. Iyer at The University of Texas MD Anderson Cancer Center. This open-label, multi-center study aims to assess the safety and optimal dosing of LB1901 for patients with unmet medical needs in these serious conditions.
Legend Biotech Corporation (NASDAQ: LEGN) announced its participation in the 19th Annual Morgan Stanley Virtual Global Healthcare Conference on September 10. CEO and CFO Ying Huang will represent the company at 8:45 a.m. Eastern Time. Investors can access the conference webcast on the Legend Biotech website. The company focuses on developing novel cell therapies for oncology, notably its lead candidate cilta-cel for multiple myeloma, currently in registrational clinical trials. With over 900 employees across the U.S., China, and Europe, Legend Biotech is poised to advance innovative treatments.
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.