Legend Biotech Corp Stock Price, News & Analysis

Legend Biotech Corporation (NASDAQ: LEGN) announced the acceptance of its New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel) by China's NMPA. This application is based on the CARTIFAN-1 Phase 2 clinical study data, focusing on patients with relapsed or refractory multiple myeloma who have undergone multiple prior therapies. The study indicated significant efficacy and safety of cilta-cel, addressing a critical unmet medical need due to rising incidence rates of multiple myeloma in China. Cilta-cel is already approved in the U.S., Japan, and has conditional authorization in Europe.

Legend Biotech Corporation (NASDAQ: LEGN) has announced its participation in several upcoming investor conferences. The events include the BMO Biopharma Spotlight Series: Oncology Day on November 9, 2022, and the Cowen 6th Annual IO Next Summit on November 11, 2022, both featuring presentations by CEO Ying Huang, Ph.D. Further conferences will take place in Miami on November 14, London on November 17, and New York on November 29, culminating with the Evercore ISI 5th Annual HealthCONx Conference on November 30, 2022.

Legend Biotech Corporation (NASDAQ: LEGN) announced that seven studies on its CAR-T therapy, ciltacabtagene autoleucel (cilta-cel), have been accepted for presentation at the 64th American Society of Hematology (ASH) Annual Meeting. This includes data on sustained minimal residual disease negativity from the pivotal CARTITUDE-1 study and the first presentation of CARTIFAN-1 study results in heavily pretreated Chinese patients. Presentations will highlight ongoing clinical development and long-term follow-up data, reaffirming the potential of cilta-cel to significantly impact multiple myeloma treatment.

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.