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 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.
Legend Biotech Corporation (NASDAQ: LEGN) announced that the FDA has accepted the Biologics License Application for cilta-cel, a CAR-T therapy aimed at treating relapsed or refractory multiple myeloma, under priority review. The PDUFA target action date is set for November 29, 2021. Cilta-cel has previously received Breakthrough Therapy Designation, indicating significant potential benefits for patients. Ying Huang, CEO, emphasized the importance of this milestone as the company collaborates with Janssen Biotech to expedite this innovative treatment.