Articles from Legend Biotech Corporation

Legend Biotech Corporation (NASDAQLEGN) (Legend Biotech), a global leader in cell therapy, today announced that Ying Huang, Ph.D., the company’s Chief Executive Officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference in New York, NY on Thursday, June 6, 2024, at 10:30 a.m. ET.

Legend Biotech Corporation (NASDAQLEGN) (Legend Biotech), a global leader in cell therapy, announced today that new and updated data from the CARTITUDE clinical development program evaluating CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for patients with multiple myeloma will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2024 European Hematology Association’s (EHA) Hybrid Congress.

Legend Biotech Corporation (NASDAQLEGN) (Legend Biotech), a global leader in cell therapy, today reported its first quarter 2024 unaudited financial results and key corporate highlights.

Legend Biotech Corporation (NASDAQLEGN) (Legend Biotech), a global leader in cell therapy, announced today that the European Commission (EC) has granted approval of CARVYKTI® (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), have demonstrated disease progression on the last therapy and are refractory to lenalidomide.

Legend Biotech Corporation (NASDAQLEGN) (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.

Legend Biotech Corporation (NASDAQLEGN) (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 or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor (PI), and an immunomodulatory agent (IMiD), and are refractory to lenalidomide.1 CARVYKTI® is the first and only B-cell Maturation Antigen (BCMA) targeted therapy, including CAR-T therapies, bispecific antibodies, and antibody-drug conjugates (ADCs), approved starting in the second-line of treatment for patients with multiple myeloma.

Legend Biotech Corporation (NASDAQLEGN) (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, the Company’s ESG data collection and disclosure roadmap, and future growth areas in its ESG journey.

Legend Biotech Corporation (NASDAQLEGN) (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 autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and are refractory to lenalidomide. The positive recommendation follows the committee’s evaluation of efficacy and safety data from the Phase 3 CARTITUDE-4 study. The committee voted unanimously in favor of CARVYKTI (11 to 0) finding the risk-benefit assessment of cilta-cel for the proposed indication as favorable. A supplemental Biologics License Application (sBLA) supported by the CARTITUDE-4 study is currently under review by the FDA with a target Prescription Drug User Fee Act (PDUFA) date of April 5, 2024.

Legend Biotech Corporation (NASDAQLEGN) (Legend Biotech), a global leader in cell therapy, today reported its fourth quarter and full year 2023 unaudited financial results and key corporate highlights.

Legend Biotech Corporation (NASDAQLEGN) (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 expansion of the CARVYKTI® label to include adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide. The Type II variation application was submitted to the EMA by Janssen-Cilag International N.V., an affiliate of Janssen Biotech, Inc., Legend Biotech’s collaborator for the development and commercialization of CARVYKTI®. The positive opinion from the CHMP will now be reviewed by the European Commission which renders the final decision on approval.

Legend Biotech Corporation (NASDAQLEGN) (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.

Legend Biotech Corporation (NASDAQLEGN) (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 targeting Delta-like ligand protein 3 (DLL3), including Legend Biotech’s existing autologous CAR-T cell therapy candidate, LB2102 (NCT05680922).1 Under the terms of the license agreement, Legend Biotech will receive a $100 million upfront cash payment.

Legend Biotech Corporation (NASDAQLEGN) (Legend Biotech), a global biotechnology company developing, manufacturing, and commercializing novel therapies to treat life-threatening diseases, today announced its participation in the 42nd annual J.P. Morgan Healthcare Conference in San Francisco, CA. Ying Huang, Ph.D., the company’s chief executive officer, will deliver the company presentation on Tuesday, January 9, 2024, at 2:15 p.m. PT.

Legend Biotech Corporation (NASDAQLEGN) (Legend Biotech), a global biotechnology company developing, manufacturing, and commercializing novel therapies to treat life-threatening diseases, announced today patient-reported outcome (PRO) data from the Phase 3 CARTITUDE-4 study from an oral presentation at the 2023 American Society of Hematology (ASH) Annual Meeting (Abstract #1063). These data showed clinically meaningful improvement in health-related quality of life following a single CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) infusion in adults lenalidomide-refractory multiple myeloma (MM) who received one to three prior lines of therapy (LOT), compared to patients treated with the standard of care (SOC) treatment regimens of either pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).1 The PRO data also demonstrated meaningful reductions in disease-specific symptoms after a single infusion for patients in the CARVYKTI® arm, while patients in the SOC treatment arm trended toward worsening or lower degrees of improvement from baseline for most domains and symptoms.

Legend Biotech Corporation (NASDAQLEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today reported its unaudited financial results for the three and nine months ended September 30, 2023 and key corporate highlights.

Legend Biotech Corporation (NASDAQLEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that Legend Biotech Ireland Limited, a wholly owned subsidiary of Legend Biotech, has entered into an exclusive, global license agreement (License Agreement) with Novartis Pharma AG for certain Legend Biotech chimeric antigen receptor T-cell (CAR-T) cell therapies targeting DLL3, including its autologous CAR-T cell therapy candidate, LB2102 (NCT05680922).1 The License Agreement grants Novartis the exclusive worldwide rights to develop, manufacture and commercialize these cell therapies, and Novartis may apply its T-Charge™ platform to their manufacture.

Legend Biotech Corporation (NASDAQLEGN) (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 performance for the quarter.

Legend Biotech Corporation (“Legend Biotech” or the “Company”) (NASDAQLEGN), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced that two oral presentations and five poster presentations featuring new and updated data from the CARTITUDE clinical development program evaluating ciltacabtagene autoleucel (cilta-cel) will be presented at the 65th American Society of Hematology Annual Meeting and Exposition taking place in San Diego from December 9-12.

Legend Biotech Corporation (NASDAQLEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today reported its unaudited financial results for the three and six months ended June 30, 2023.

Legend Biotech Corporation (NASDAQLEGN) (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 performance for the quarter.

Legend Biotech Corporation (NASDAQLEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA). The sBLA seeks to expand the label for CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) to include the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.

Legend Biotech Corporation (NASDAQLEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that a Type II variation application was submitted to the European Medicines Agency (EMA) for CARVYKTI® based on data from the CARTITUDE-4 study (NCT04181827), which investigates the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received one to three prior lines of therapy. The submission was filed to the EMA by Janssen-Cilag International N.V., an affiliate of Janssen Biotech, Inc., Legend Biotech’s collaborator for the development and commercialization of cilta-cel.

Legend Biotech Corporation (NASDAQLEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today reported its first quarter 2023 unaudited financial results.

Legend Biotech Corporation (“Legend Biotech” or the “Company”) (NASDAQLEGN), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced that new and updated data from the CARTITUDE Clinical Development Program 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. Five-year follow-up data from Legend-2 (NCT03090659), an investigator-initiated trial that has been assessing a similar CAR construct since 2015, will also be presented at the meetings.

Legend Biotech Corporation (NASDAQLEGN) (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 on Wednesday, May 17, 2023 at 9:30 a.m. (Eastern Time).

Legend Biotech Corporation (NASDAQLEGN) (“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 direct offering. The gross proceeds of the offering are expected to be approximately $350 million, before offering expenses, which together with the Company’s existing cash and cash equivalents, will enable the Company to fund its planned operating expenses and capital expenditures through the fourth quarter of 2025. All ADSs to be sold in the offering will be sold by Legend Biotech. The offering is expected to close on or about May 10, 2023, subject to customary closing conditions.

Legend Biotech Corporation (NASDAQLEGN), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that seven company-sponsored studies were accepted for presentation at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans.

Legend Biotech Corporation (NASDAQLEGN), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved CARVYKTI™ (ciltacabtagene autoleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adults with relapsed or refractory multiple myeloma, limited to cases meeting both of the following conditions:

Legend Biotech Corporation (NASDAQLEGN) (Legend Biotech), a global, biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today in conjunction with an announcement to be issued by Legend Biotech’s majority shareholder, GenScript Biotech Corporation, pursuant to the rules of The Stock Exchange of Hong Kong Limited, announced preliminary, unaudited financial results for the six-months ended June 30, 2022.

Legend Biotech Corporation (NASDAQLEGN) (“Legend Biotech”), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced that it has priced an underwritten public offering of 8,140,000 American Depositary Shares (“ADSs”), each representing two ordinary shares, at a public offering price of $43.00 per ADS, for total gross proceeds of approximately $350 million. In addition, Legend Biotech has granted the underwriters a 30-day option to purchase up to an additional 1,221,000 ADSs at the public offering price, less underwriting discounts and commissions. All of the ADSs are being offered by Legend Biotech. The offering is expected to close on July 29, 2022, subject to customary closing conditions.

Legend Biotech Corporation (NASDAQLEGN) (“Legend Biotech”), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced that it intends to offer and sell $250 million of American Depositary Shares (“ADSs”), each representing two ordinary shares, in an underwritten public offering. All ADSs to be sold in the proposed offering will be offered by Legend Biotech. Legend Biotech also intends to grant the underwriters a 30-day option to purchase up to an additional $37.5 million of ADSs sold in the public offering at the public offering price, less underwriting discounts and commissions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed or the actual size or terms of the offering.

Legend Biotech Corporation (NASDAQLEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced the appointment of Guowei Fang, Ph.D., as Senior Vice President, Global Head of Research and Early Development.

Legend Biotech Corporation (NASDAQLEGN) (Legend Biotech), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, will virtually participate in the 40th Annual J.P. Morgan Healthcare Conference. Ying Huang, PhD, CEO and CFO of Legend Biotech, will deliver the company presentation on Tuesday, January 11, 2022 at 2:15 p.m. (Eastern Time).

Legend Biotech Corporation (NASDAQLEGN) (“Legend Biotech”), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, announced today that Dr. Ying Huang, Legend Biotech’s Chief Executive Officer and Chief Financial Officer, has been appointed as a director to Legend Biotech’s Board of Directors. Dr. Huang will serve as a Class I director.

Legend Biotech Corporation (NASDAQLEGN) (“Legend Biotech”), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced that it has priced an underwritten public offering of 7,500,000 American depositary shares (“ADSs”), each representing two ordinary shares, at a public offering price of $40.00 per ADS, for total gross proceeds of approximately $300.0 million. In addition, Legend Biotech has granted the underwriters a 30-day option to purchase up to an additional 1,125,000 ADSs at the public offering price, less underwriting discounts and commissions. All of the ADSs are being offered by Legend Biotech. The offering is expected to close on December 20, 2021, subject to customary closing conditions.

Legend Biotech Corporation (NASDAQLEGN) (“Legend Biotech”), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced that it intends to offer and sell $300.0 million of American Depositary Shares (“ADSs”), each representing two ordinary shares, in an underwritten public offering. All ADSs to be sold in the proposed offering will be offered by Legend Biotech. Legend Biotech also intends to grant the underwriters a 30-day option to purchase up to an additional $45.0 million of ADSs sold in the public offering at the public offering price, less underwriting discounts and commissions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed or the actual size or terms of the offering.

Legend Biotech Corporation (NASDAQLEGN), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, announced today the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) for ciltacabtagene autoleucel (cilta-cel) by its collaboration partner, Janssen Pharmaceutical K.K. (Janssen). Cilta-cel is an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR)-T cell therapy for the treatment of adults with relapsed or refractory multiple myeloma who have received at least three prior therapies, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 antibody.

Legend Biotech Corporation (NASDAQLEGN) (Legend Biotech), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, today announced that 12 company-sponsored studies were accepted for presentation at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition. These include two oral presentations and 10 poster presentations.

Legend Biotech Corporation (NASDAQLEGN) (“Legend Biotech”), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced it will present at the Jefferies Virtual Healthcare Conference on June 3, 2021 at 9:30 am ET. This webcast will be available to investors and other interested parties by accessing the Legend Biotech website at https://investors.legendbiotech.com

Legend Biotech Corporation (NASDAQLEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today reported its unaudited financial results for the first quarter of 2021.

Legend Biotech Corporation (NASDAQLEGN) (“Legend Biotech”), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, announced today the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of ciltacabtagene autoleucel (cilta-cel) for the treatment of patients with relapsed and/or refractory multiple myeloma.