Legend Biotech Corporation American Depositary Shares - LEGN STOCK NEWS

Legend Biotech announces that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended the marketing authorization of CARVYKTI™ (ciltacabtagene autoleucel) for treating adults with relapsed and refractory multiple myeloma. This recommendation is pivotal for Legend Biotech as it hopes to gain EC approval, marking the company’s first EC-approved product. The therapy, developed in collaboration with Janssen Pharmaceutica, has shown promising results in the ongoing CARTITUDE-1 study. The FDA previously approved cilta-cel on February 28, 2022.

Janssen Pharmaceutical Companies announced a positive recommendation from the European Medicines Agency's CHMP for cilta-cel, a CAR-T therapy targeting relapsed and refractory multiple myeloma in adults with prior therapy failures. Cilta-cel, developed in collaboration with Legend Biotech, is supported by pivotal CARTITUDE-1 study data and aims to provide new treatment options for this challenging disease. The therapy received FDA approval in February 2022 and addresses an urgent need in multiple myeloma treatment.

Legend Biotech Corporation (NASDAQ: LEGN) has been awarded the Newcomer of the Year at the Foreign Investment Trophy ceremony by Flanders Investment & Trade in Belgium. The company received this recognition for its substantial investment in a cutting-edge manufacturing facility in Flanders, a collaboration with Janssen Pharmaceutica N.V. This facility will be the first dedicated cell therapy manufacturing site in the region and is designed to produce cilta-cel, a CAR-T therapy for multiple myeloma. The site is projected to be operational in 2023.

Legend Biotech announced the FDA approval of CARVYKTI™ (ciltacabtagene autoleucel) for treating adults with relapsed/refractory multiple myeloma after four prior therapies. The company reported unaudited Q4 2021 financial results, showing a revenue decrease to $39 million from $40.8 million in Q4 2020, while annual revenue rose to $89.8 million from $75.7 million. R&D expenses increased by 29% in Q4 and 35% for 2021, totaling $313.3 million. Net losses for Q4 and the full year were $88.3 million and $386.2 million, respectively, reflecting ongoing commercialization efforts.

Rocket Pharmaceuticals (NASDAQ: RCKT) has appointed Jessie Yeung as Vice President of Investor Relations and Corporate Finance. With over 15 years of experience, including a previous role at Legend Biotech (NASDAQ: LEGN), Yeung will lead investor relations and capital market strategies. CEO Gaurav Shah emphasized Yeung's expertise will enhance communication with investors as the company approaches significant milestones in gene therapy clinical programs.

Legend Biotech has received FDA approval for its first product, CARVYKTI™ (ciltacabtagene autoleucel), targeting adults with relapsed or refractory multiple myeloma who previously underwent four or more lines of therapy. Based on the pivotal CARTITUDE-1 study, CARVYKTI™ demonstrated a high overall response rate of 98%, with 78% achieving stringent complete response. The product will be available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). CEO Ying Huang considers this approval a significant milestone for the company, expected to fulfill an unmet need in the treatment of multiple myeloma.

Legend Biotech (NASDAQ: LEGN) announced preliminary, unaudited financial results for the year ended December 31, 2021. The company expects a loss of approximately US$365.3M to US$397.4M, with R&D expenses between US$297.9M and US$321.8M primarily due to investments in its lead candidate, cilta-cel. Additionally, a non-cash fair value loss of US$5.7M to US$6.4M is anticipated related to warrant liability changes. As of December 31, 2021, Legend Biotech reported around US$688.9M in cash and cash equivalents, emphasizing its financial stability despite significant expected losses.

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.