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.
Overview of Legend Biotech Corp
Legend Biotech Corp (NASDAQ: LEGN) is a clinical-stage biopharmaceutical company dedicated to harnessing cutting-edge cell therapy and CAR-T immunotherapy technologies to revolutionize the treatment of cancer, particularly multiple myeloma and other oncology indications. With a robust pipeline of chimeric antigen receptor (CAR) product candidates, the company leverages advanced scientific research and decades of expertise in molecular biology and immunology to address previously unmet medical needs in oncology.
Core Business and Strategic Focus
The core business of Legend Biotech revolves around the discovery, development, and clinical application of next-generation cell therapies. The company utilizes its proprietary platforms to develop CAR-T cell therapies that are designed to target and eliminate malignant cells in patients with liquid and solid tumors. By focusing on cancers that have long been considered incurable, such as multiple myeloma, Legend Biotech aims to improve treatment outcomes and extend patient survival. The company generates revenue through strategic licensing and collaboration agreements, partnering with established industry players to expand the reach of its innovative therapies.
Research, Development, and Innovation
Legend Biotech is recognized for its commitment to research and development. The company operates multiple R&D sites around the globe, ensuring a diverse and comprehensive approach to clinical research. Its teams of immunologists and molecular biologists work collaboratively to fine-tune CAR-T cell constructs and other cell-based therapies. This rigorous R&D approach has resulted in a strong pipeline of product candidates that undergo extensive clinical trials, with several therapies demonstrating promising efficacy in early and advanced stages of clinical evaluation.
Technology Platform and Pipeline
The company’s technology platform is built on the complex science of cellular engineering, enabling the development of both autologous and allogeneic cell therapies. These therapies often involve the genetic modification of a patient’s own immune cells to enhance their ability to recognize and kill cancer cells. A key product in its portfolio is a BCMA-targeted CAR-T cell therapy, which has shown significant clinical potential in treating relapsed or refractory multiple myeloma. This approach not only refines the patient’s immune response but also opens avenues for additional therapeutic applications across various oncologic disorders.
Market Position and Collaborative Strength
Within the competitive landscape of biopharmaceutical innovation, Legend Biotech positions itself as a vital contributor to the next generation of cancer treatment. The company’s involvement in high-profile clinical trials and its collaboration with major industry partners underscore its authoritative presence in the field. Its licensing and collaboration agreements with renowned organizations further reinforce its scientific credibility and operational robustness, positioning the company as an important player in global oncology research and treatment development.
Pipeline and Clinical Impact
Legend Biotech’s pipeline reflects its dedication to transforming cancer treatment paradigms. The company’s clinical trials have evaluated the safety and efficacy of its CAR-T therapies among diverse patient groups. These studies are designed to demonstrate not only impressive clinical responses but also enhancements in overall survival and quality of life among patients with challenging oncologic diagnoses. By rigorously testing its product candidates in multiple clinical settings, Legend Biotech contributes valuable data to the scientific community and paves the way for the broader adoption of cell therapies in routine clinical practice.
Scientific Rigor and Regulatory Engagement
Undergirding its product development is a strong commitment to scientific rigor and regulatory compliance. Legend Biotech adheres to strict quality standards in the development and manufacturing of its therapies, ensuring both efficacy and patient safety. Its active engagement with regulatory bodies worldwide reflects a proactive approach to meeting global standards, thereby enhancing the trust of both patients and healthcare providers in its therapies.
Commitment to Advancing Oncology Treatment
At its core, Legend Biotech is driven by the vision of overcoming the long-standing challenges in cancer treatment. By advancing the science of cell therapies, the company seeks to offer novel, potentially transformative treatments that redefine the standard of care in oncology. Its comprehensive approach, which integrates innovative research, deep scientific expertise, and strategic collaborations, enables Legend Biotech to contribute meaningfully to the evolving landscape of immunotherapy and personalized medicine.
Key Highlights
- Innovative Cell Therapies: Focused on CAR-T cell therapies for addressing difficult-to-treat cancers, especially in the field of oncology.
- Advanced R&D: Multiple research centers globally support expansive R&D efforts and clinical trials.
- Collaborative Revenue Model: Strategic licensing and collaboration agreements enhance scientific advancement and market reach.
- Clinical Expertise: Demonstrated capabilities in conducting rigorous clinical trials and generating actionable clinical data.
- Regulatory Engagement: Active interactions with regulatory agencies ensure adherence to high quality and safety standards.
Conclusion
Legend Biotech Corp stands as a formidable entity in the field of biotechnology, focusing on the development of best-in-class immunotherapies. Through its innovative cell therapy platforms and robust clinical research programs, the company is committed to revolutionizing cancer treatment and improving patient outcomes in oncology. Its deep scientific expertise, combined with a strategic approach to R&D and global collaborations, solidifies its reputation as an authoritative and trustworthy source in the biopharmaceutical landscape.
Legend Biotech Corporation (NASDAQ: LEGN) announced that its Phase 1 clinical trial for LB1901, an investigational CAR-T therapy for relapsed T-cell lymphoma, has been placed on clinical hold by the U.S. FDA. This decision follows the company’s prior voluntary pause due to low CD4+ T-cell counts in the trial patient. Although the patient has not experienced any serious adverse events, the FDA will issue an official clinical hold letter by March 11, 2022. The company is committed to monitoring the patient while addressing the FDA's concerns.
Legend Biotech Corporation (NASDAQ: LEGN) has secured $50 million in milestone payments under its collaboration with Janssen Biotech for ciltacabtagene autoleucel (cilta-cel), a CAR-T therapy for multiple myeloma. The agreement, which grants Legend a 50-50 cost and profit share globally (70-30 in Greater China), has resulted in $250 million in total milestone payments so far. Cilta-cel, designated as a Breakthrough Therapy and Orphan Drug, is under regulatory review by the FDA and EMA for treating relapsed or refractory multiple myeloma.
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.
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