Legend Biotech Corporation American Depositary Shares - LEGN STOCK NEWS

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.

The U.S. FDA has approved CARVYKTI™ (ciltacabtagene autoleucel) for treating adults with relapsed or refractory multiple myeloma, marking Legend Biotech's first product approval. The EC also granted conditional marketing authorization for the same indication. The company achieved a $50 million milestone from its collaboration with Janssen Biotech. For Q1 2022, Legend reported revenues of $40.8 million, up from $13.7 million YoY, primarily from milestone payments. However, R&D expenses rose to $81.3 million, leading to a net loss of $41.1 million.

Legend Biotech Corporation (NASDAQ: LEGN) will host an investor event on June 5, 2022, at 6 pm Central Time during the ASCO Annual Meeting. Dr. Sundar Jagannath from Mount Sinai will present new data from the CARTITUDE Clinical Development Program for cilta-cel, a CAR-T therapy targeting multiple myeloma. Investors can attend in person or virtually via Legend Biotech's website. The company focuses on innovative cell therapies for life-threatening diseases and aims to advance treatment options for patients globally.

Legend Biotech Corporation (NASDAQ: LEGN) announces that the European Commission has granted conditional marketing authorization for CARVYKTI® (ciltacabtagene autoleucel) to treat adults with relapsed and refractory multiple myeloma. This approval is based on the pivotal CARTITUDE-1 study, which demonstrated a remarkable 98% overall response rate. The therapy, developed in collaboration with Janssen Biotech, targets BCMA and is administered as a single infusion. This marks a significant milestone for the company in Europe.

Legend Biotech announced the presentation of pivotal long-term follow-up data from the CARTITUDE-1 study supporting the recent FDA approval of CARVYKTI™ (ciltacabtagene autoleucel) for multiple myeloma. At the ASCO and EHA 2022 meetings, the company will showcase updates from the CARTITUDE clinical development program, including results from Cohorts A and B of the CARTITUDE-2 study. These studies assess cilta-cel's efficacy in various treatment settings for relapsed or refractory multiple myeloma.

Legend Biotech Corporation has promoted Lori Macomber, CPA, to Chief Financial Officer (CFO), effective immediately. She takes over from Dr. Ying Huang, who remains the Chief Executive Officer. Lori has been with the company since September 2019, serving in various financial roles including Vice President of Finance. Recognized for her financial expertise, she aims to drive sustainable growth as the company transitions into a fully commercial organization. Legend Biotech continues to focus on developing advanced therapies for life-threatening diseases.

Legend Biotech Corporation (NASDAQ: LEGN) announced participation in several key investor conferences in May and June 2022. The first event is the Bank of America Securities 2022 Healthcare Conference, scheduled for May 11, 2022, at 5:20 PM PT in Las Vegas, with CEO Ying Huang presenting. This will be followed by the Jefferies Global Healthcare Conference on June 8, 2022, at 1:00 PM PT in New York, and the Goldman Sachs Annual Global Healthcare Conference on June 15, 2022, at 1:20 PM PT in California.

Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) reported a net loss of $43M, or $0.67 per share, for Q1 2022. The company holds $346.6M in cash, extending its operational runway into H1 2024. Key updates include the advancement of four clinical programs targeting Danon Disease, Fanconi Anemia, Leukocyte Adhesion Deficiency-I, and Pyruvate Kinase Deficiency, with data readouts expected throughout 2022. Significant leadership appointments were made, including Fady Malik, M.D., to the Board and Carlos Martin as Chief Commercial Officer. The company also anticipates AAV cGMP manufacturing readiness in Q2 2022.

Legend Biotech Corporation (NASDAQ: LEGN) announced a $50 million milestone achievement in its collaboration with Janssen Biotech for the CAR-T therapy, CARVYKTI™ (ciltacabtagene autoleucel), used to treat multiple myeloma. This brings total milestone payments received to $300 million under the agreement, which includes a 50-50 cost and profit-sharing model globally, except in Greater China, where Legend retains 70%. The FDA approved CARVYKTI™ for adult patients with relapsed or refractory multiple myeloma in February 2022.