Legend Biotech Corporation American Depositary Shares - LEGN STOCK NEWS

Legend Biotech Corporation (NASDAQ: LEGN) has received approval from Japan’s Ministry of Health for its CAR-T therapy, CARVYKTI™ (ciltacabtagene autoleucel), aimed at treating adults with relapsed or refractory multiple myeloma. This therapy is limited to patients with no history of CAR-positive T cell therapy and those who have undergone three or more treatment lines. The approval is based on promising data from the pivotal CARTITUDE-1 study, where 96.9% of non-Japanese patients showed a response, with 67% achieving a stringent complete response.

Legend Biotech Corporation (NASDAQ: LEGN) will host its in-person and virtual Research & Development Day on October 3, 2022, at 10:00 a.m. ET in New York City. The event aims to provide a comprehensive overview of the company's platforms and pipeline developments from its senior leadership team, including CEO Ying Huang and other key executives. A live webcast will be accessible, with a replay available within 24 hours post-event. Investors can register here.

Legend Biotech Corporation (NASDAQ: LEGN) announced participation in several key investor conferences: Citi's 17th Annual BioPharma Conference on September 7, 2022, Wells Fargo Healthcare Conference on September 8, 2022, and the Morgan Stanley Global Healthcare Conference on September 12, 2022, all featuring CEO Ying Huang, Ph.D. Additionally, the company will attend the Jefferies Cell and Genetic Medicine Summit on September 29-30, 2022. Legend Biotech focuses on developing innovative therapies for life-threatening diseases from its headquarters in Somerset, New Jersey.

Legend Biotech Corporation (NASDAQ: LEGN) reported preliminary, unaudited financial results for the six months ended June 30, 2022. The company anticipates a loss between US$196 million and US$228.9 million, primarily due to R&D investments in its lead product candidate, cilta-cel. An adjusted loss is expected between US$144.5 million and US$168.6 million. Additionally, a non-cash fair value loss of US$27.9 million to US$32.6 million from warrant liability changes is projected. As of June 30, 2022, cash and equivalents totaled approximately US$379.8 million.

Legend Biotech Corporation (NASDAQ: LEGN) announced the appointment of three new directors to its Board: Mr. Tomas Heyman (Class I), Dr. Fangliang "Frank" Zhang (Class II), and Dr. Li Mao (Class III). The Board emphasized that these individuals possess essential skills for executing the company’s long-term strategy. Sally Wang resigned as Chair but will continue as a director. Dr. Zhang has been elected Chairman of the Board. The changes aim to strengthen leadership as the company advances its development of innovative therapies.

Legend Biotech has announced an underwritten public offering of 8,140,000 American Depositary Shares (ADSs) at a price of $43.00 per ADS, aiming for approximately $350 million in total gross proceeds. The underwriters also hold a 30-day option to purchase an additional 1,221,000 ADSs. The offering is expected to close on July 29, 2022, pending customary conditions. Morgan Stanley, J.P. Morgan, Jefferies, and Evercore ISI are leading the offering. The ADSs are being sold under an effective shelf registration statement with the SEC.

Legend Biotech Corporation (NASDAQ: LEGN) plans to offer $250 million of American Depositary Shares (ADSs), each representing two ordinary shares, in an underwritten public offering. The company has also granted underwriters a 30-day option to purchase an additional $37.5 million of ADSs. The offering is subject to market conditions and does not guarantee completion. Morgan Stanley, J.P. Morgan, Jefferies, and Evercore ISI are the joint book-running managers. The ADSs will be offered under a previously filed effective shelf registration statement with the SEC.

Legend Biotech presented updated results from the CARTITUDE clinical program for cilta-cel at the ASCO 2022 meeting, showcasing a sustained 98% overall response rate in relapsed or refractory multiple myeloma patients after 28 months. Median progression-free and overall survival times remain unreached, highlighting long-term efficacy. The CARTITUDE-2 study supports the use of cilta-cel in earlier treatment lines, with 95% of patients achieving a complete response. Adverse events were consistent with previous findings, primarily hematologic.

Legend Biotech Corporation (NASDAQ: LEGN) has received FDA clearance for its investigational new drug (IND) application to evaluate LB1908 in a Phase 1 clinical trial targeting Claudin 18.2 in patients with advanced gastric, esophageal, or pancreatic cancers. The trial aims to assess safety, tolerability, and preliminary efficacy, focusing on patients expressing Claudin 18.2. This innovative CAR-T therapy represents a new treatment avenue for serious cancer types, which currently have low survival rates. An ongoing investigator-initiated trial in China is also evaluating LB1908.