Legend Biotech Corp Stock Price, News & Analysis

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.

Legend Biotech Corporation (NASDAQ: LEGN) will participate in the 40th Annual J.P. Morgan Healthcare Conference virtually on Tuesday, January 11, 2022, at 2:15 p.m. ET. CEO Ying Huang will present, and the live webcast will be accessible on the Legend Biotech website. The company focuses on developing cell therapies targeting life-threatening diseases.

Notably, their lead product, ciltacabtagene autoleucel, is under regulatory review for treating multiple myeloma, with evaluations by the FDA and EMA ongoing.

Legend Biotech Corporation (NASDAQ: LEGN) announced the appointment of Dr. Ying Huang, CEO and CFO, to its Board of Directors as a Class I director. Dr. Huang, who has led the company since September 2020 and has extensive experience in biotech equity research, is expected to enhance the board's governance. The company is also focused on advancing its lead product candidate, ciltacabtagene autoleucel, for multiple myeloma treatment, which is under regulatory review by health authorities including the FDA and EMA.

Legend Biotech Corporation (NASDAQ: LEGN) has announced an underwritten public offering of 7,500,000 American depositary shares (ADSs) at $40.00 each, aiming for gross proceeds of approximately $300.0 million. An additional 1,125,000 ADSs may be purchased by underwriters within 30 days. The offering, set to close on December 20, 2021, is made under an effective shelf registration statement with the SEC. The proceeds are expected to bolster Legend Biotech's development of innovative cell therapies, including its lead candidate for multiple myeloma.

Legend Biotech Corporation (NASDAQ: LEGN) announced plans to offer $300 million of American Depositary Shares (ADSs), each representing two ordinary shares, in a public offering. Additionally, they may allow underwriters a 30-day option to purchase up to $45 million more in ADSs. The offering is contingent upon market conditions and will be conducted under a previously effective shelf registration statement with the SEC. Leading financial institutions, including Morgan Stanley and J.P. Morgan, are managing the offering.

Legend Biotech (NASDAQ: LEGN) presented new data from the CARTITUDE clinical development program for cilta-cel at the 2021 ASH Annual Meeting. Updated results from the CARTITUDE-1 study showed a 98% overall response rate and an 83% stringent complete response rate after nearly two years. The study also reported 61% progression-free and 74% overall survival rates at two years. The CARTITUDE-2 study results indicated a 95% overall response rate in patients with early relapse. Safety profiles remained manageable with no new adverse events reported.

Janssen Pharmaceutical Companies of Johnson & Johnson announced promising long-term results from the Phase 1b/2 CARTITUDE-1 study of ciltacabtagene autoleucel (cilta-cel) for relapsed/refractory multiple myeloma. At a median follow-up of 22 months, 83% of patients achieved a stringent complete response, while 92% of evaluable patients achieved minimal residual disease negativity. Median progression-free survival and overall survival were not reached, with two-year rates of 61% and 74%, respectively. The safety profile remained consistent, and no new safety signals were observed.

GenScript ProBio has inaugurated China's largest GMP plasmid manufacturing facility in Zhenjiang, Jiangsu Province, enhancing its service offerings for plasmids used in cell and gene therapy. The 6,400-square-meter plant significantly increases production capacity and positions the company as a leading Contract Development and Manufacturing Organization (CDMO). It provides comprehensive plasmid services from preclinical studies to commercial manufacturing, supporting mRNA vaccine development and clinical trial approvals globally, including in China and South Korea.

Legend Biotech Corporation (NASDAQ: LEGN) announced the submission of a New Drug Application (NDA) for its CAR-T cell therapy, ciltacabtagene autoleucel (cilta-cel), to Japan's Ministry of Health. This submission is based on pivotal data from the CARTITUDE-1 study targeting adults with relapsed or refractory multiple myeloma. Cilta-cel has received several designations, including Breakthrough Therapy Designation. The ongoing international regulatory review underscores its potential to address significant treatment gaps for patients with limited options.