SOMERSET, N.J. / Apr 11, 2024 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, will host a conference call for investors at 8:00 am ET on Monday, May 13, 2024, to review first-quarter 2024 results. During the webcast and conference call, senior leaders will provide an overview of Legend Biotech’s performance for the quarter. Investors and other interested parties... Read More

New indication for this one-time infusion may provide patients with a treatment-free respite as early as first relapse SOMERSET, N.J. / Apr 05, 2024 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, announced today the U.S. Food and Drug Administration (FDA) has approved CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) for the treatment of patients with relapsed... Read More

SOMERSET, N.J. / Mar 19, 2024 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today released its inaugural Environmental, Social & Governance (ESG) report . The inaugural report provides an overview of Legend Biotech’s ESG program and reporting in alignment with the Sustainable Accounting Standards Board (“SASB”) Biotechnology and Pharmaceutical sector standards,... Read More

FDA ODAC votes 11 to 0 supporting favorable risk-benefit assessment of CARVYKTI based on results from the Phase 3 CARTITUDE-4 study SOMERSET, N.J. / Mar 15, 2024 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended CARVYKTI ® (ciltacabtagene... Read More

CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) net trade sales of approximately $159 million and $500 million for the fourth quarter and full year 2023, respectively CHMP recommended CARVYKTI ® label expansion in earlier lines of treatment for adult patients with relapsed and lenalidomide-refractory multiple myeloma. FDA ODAC to meet on March 15 to review data from the CARTITUDE-4 study supporting the use of cilta-cel in... Read More

CARVYKTI ® is the first CAR-T therapy for patients with relapsed and refractory multiple myeloma to receive a positive CHMP opinion for second line treatment SOMERSET, N.J. / Feb 23, 2024 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, announced today the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended... Read More

SOMERSET, N.J. / Feb 13, 2024 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing, and commercializing novel therapies to treat life-threatening diseases, will host a conference call for investors at 8:00 am ET on Monday, March 11, 2024, to review fourth-quarter and full-year 2023 results. During the webcast and conference call, executive... Read More

SOMERSET, N.J. / Jan 03, 2024 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing, and commercializing novel therapies to treat life-threatening diseases, closed its previously announced exclusive, worldwide license agreement with Novartis Pharma AG (Novartis) for certain Legend Biotech chimeric antigen receptor T-cell (CAR-T) cell therapies... Read More

SOMERSET, N.J. / Jan 02, 2024 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing, and commercializing novel therapies to treat life-threatening diseases, today announced its participation in the 42 nd annual J.P. Morgan Healthcare Conference in San Francisco, CA. Ying Huang, Ph.D., the company’s chief executive officer, will deliver the... Read More

In CARTITUDE-4, CARVYKTI® demonstrated clinically meaningful improvements in patient-reported outcomes when compared to standard of care The as-treated population in CARTITUDE-4 demonstrated strong rates of progression-free survival and overall response Longer-term data from CARTITUDE-2 showed deep and durable responses in earlier lines of treatment among patients in Cohort A and Cohort B SOMERSET, N.J. / Dec 11, 2023 /... Read More

Legend Biotech Corporation (the “Company” or Legend Biotech), through its wholly owned subsidiary, Legend Biotech Ireland Limited, entered into an exclusive, global license agreement with Novartis Pharma AG. The Company granted Novartis the rights to develop, manufacture and commercialize LB2102 ( NCT05680922 ) and other potential chimeric antigen receptor T-cell (CAR-T) therapies selectively targeting Delta-like ligand 3... Read More

The deal with Novartis seeks to advance Legend Biotech’s autologous CAR-T cell therapy candidate, LB2102, and other potential CAR-T cell therapies targeting Delta-like ligand protein 3 (DLL3), using the Novartis next-generation T-Charge™ CAR-T cell therapy platform Legend Biotech will receive a $100M upfront payment and will be eligible to receive potential milestone payments plus tiered royalties on net sales SOMERSET, N.J.... Read More

SOMERSET, N.J. / Nov 07, 2023 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, will host a conference call for investors at 8:00am Eastern Time on Monday, November 20, 2023, to review third-quarter results. Company executives will provide an overview of Legend Biotech’s... Read More

Two oral presentations and five poster presentations at ASH Annual Meeting exhibit new and updated data in the clinical development program for ciltacabtagene autoleucel (cilta-cel) Patient-reported outcomes (PROs) from the CARTITUDE-4 study of cilta-cel versus standard of care in patients with lenalidomide-refractory multiple myeloma after one to three lines of therapy will be presented Updated data from Cohorts A and B of... Read More

A supplemental Biologics License Application (sBLA) was submitted to the U.S. Food and Drug Administration (FDA) and a Type II Variation Application was submitted to the European Medicines Agency (EMA) by Janssen, seeking approval of CARVYKTI ® ( ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of patients with relapsed or refractory multiple myeloma The FDA set the Prescription Drug User Fee Act target date... Read More

SOMERSET, N.J. / Aug 03, 2023 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, will host a conference call for investors at 8:00am Eastern Time on Tuesday, August 15, 2023 to review second-quarter results. Company executives will provide an overview of Legend Biotech’s... Read More

The application is supported by the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint of progression-free survival compared to standard regimens CARTITUDE-4 is the first randomized Phase 3 study investigating the efficacy and safety of cell therapy as early as after first relapse in multiple myeloma SOMERSET, N.J. / Jun 06, 2023 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN)... Read More

First analysis data from CARTITUDE-4 demonstrated a statistically significant improvement in progression-free survival, with a hazard ratio of 0.26 CARTITUDE-4 is the first randomized study investigating the efficacy of a cell therapy versus standard of care (DPd or PVd) as early as after first relapse in lenalidomide-refractory multiple myeloma Long-term results from CARTITUDE-1 and LEGEND-2 demonstrated sustained deep and... Read More

SOMERSET, N.J. / Jun 02, 2023 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced it will participate in the upcoming investor conferences: Event: Jefferies Healthcare Conference Location: New York, NY Fireside Chat Date & Time: Wednesday, June 7, 2023 at... Read More

The application to the European Medicines Agency is supported by data from the Phase 3 CARTITUDE-4 study, evaluating the safety and efficacy of cilta-cel in the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy SOMERSET, N.J. / May 25, 2023 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology... Read More

New and updated data from the CARTITUDE Clinical Development Program and LEGEND-2 study evaluating ciltacabtagene autoleucel (cilta-cel) will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association’s (EHA) 2023 Hybrid Congress $350 million in gross proceeds raised in a registered direct offering $212 million in gross proceeds raised from private placements... Read More

Eight presentations at ASCO and EHA 2023 Annual Meetings showcase continued leadership in CAR-T cell therapy research for patients with multiple myeloma across various clinical settings First analysis from the CARTITUDE-4 Phase 3 study in relapsed and lenalidomide-refractory multiple myeloma patients with one to three earlier lines of therapy to be presented as an oral presentation at ASCO and in a plenary session at EHA... Read More

SOMERSET, N.J. / May 11, 2023 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced it will participate in the 2023 RBC Capital Markets Global Healthcare Conference in New York City. Ying Huang, PhD, CEO of Legend Biotech, will participate in a fireside chat... Read More

SOMERSET, N.J. / May 08, 2023 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN) (“Legend Biotech”), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced that it has agreed to sell 5,468,750 American Depositary Shares (“ADSs”), each representing two ordinary shares of the Company, at a price of $64.00 per ADS, in a registered... Read More

SOMERSET, N.J. / Apr 11, 2023 / Business Wire / Legend Biotech Corporation (“Legend Biotech” or the “Company”) (NASDAQ: LEGN), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced the appointment of Mythili Koneru, M.D., Ph.D. as the Company’s Chief Medical Officer. In this role, Dr. Koneru will be responsible for overseeing the... Read More

SOMERSET, N.J. / Apr 03, 2023 / Business Wire / Legend Biotech Corporation (“Legend Biotech” or the “Company”) (NASDAQ: LEGN), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced the formation of a strategic advisory board and the appointments of Michel Vounatsos, former CEO of Biogen Inc., and John Maraganore, PhD, former CEO of... Read More

CARTITUDE-4, a Phase 3 study of CARVYKTI ® (ciltacabtagene autoleucel) meets primary endpoint at the study’s first pre-specified interim analysis FDA clearance of IND application for LB2102 in Extensive Stage Small Cell Lung Cancer (SCLC) CARVYKTI ® (ciltacabtagene autoleucel) receives approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with relapsed or refractory multiple... Read More

SOMERSET, N.J. / Feb 24, 2023 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced its participation in the upcoming investor conferences: Event: Cowen 43 rd Annual Healthcare Conference Location: Boston, MA Fireside Chat Date & Time: Tuesday, March 7, 2023... Read More

SOMERSET, N.J. / Feb 21, 2023 / Business Wire / Legend Biotech Corporation (“Legend Biotech” or the “Company”) (NASDAQ: LEGN), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced that it received notice from the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) on February 17, 2023 indicating that the Company has... Read More

SOMERSET, N.J. / Jan 27, 2023 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that CARTITUDE-4, the Phase 3 study evaluating CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed and lenalidomide-refractory... Read More

Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases today announced its participation in the 41st annual JP Morgan Healthcare Conference in San Francisco, CA. CEO Ying Huang, PhD will deliver the company presentation on Tuesday, January 10, 2023 at 2:15 pm (Pacific Time). About Legend... Read More

Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that China’s National Medical Products Administration (NMPA) has formally accepted its New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel). This submission is based on data from the confirmatory Phase 2... Read More