Legend Biotech Corporation American Depositary Shares - LEGN STOCK NEWS

Legend Biotech (NASDAQ: LEGN) announced new results from the Phase 3 CARTITUDE-4 study showing CARVYKTI® achieved significantly higher minimal residual disease (MRD) negativity rates compared to standard therapies in multiple myeloma patients. 89% of evaluable patients achieved MRD negativity with CARVYKTI® after three-year follow-up, versus 38% for standard therapies.

The study evaluated 208 adults receiving CARVYKTI® versus 211 receiving standard therapies. 69% of MRD-evaluable patients achieved negativity by day 56, and sustained MRD-negative ≥CR of at least 12 months was achieved in 52% versus 10% in the standard care arm. CARVYKTI® is now commercially available in five countries and has been used by over 4,500 patients.

Legend Biotech (LEGN) reported Q3 2024 results with CARVYKTI® net trade sales of $286 million, showing 87.6% year-over-year and 53.2% quarter-over-quarter growth. The company initiated commercial production at its new Obelisc facility in Belgium and received multiple regulatory approvals, including China's NMPA approval for fourth-line plus multiple myeloma treatment. Financial highlights include collaboration revenue of $142.8 million, license revenue of $17.1 million, and a net loss of $125.3 million. With $1.2 billion in cash and equivalents, Legend expects financial runway into 2026, anticipating operating profit achievement.

Legend Biotech (NASDAQ: LEGN) has announced an upcoming investor event during the 66th ASH Annual Meeting in San Diego. The live webcast is scheduled for December 8, 2024, at 8:00 p.m. PT (11:00 p.m. ET). CEO Ying Huang and CMO Mythili Koneru will host expert clinicians to discuss updates from the CARTITUDE development program. Investors can access the webcast through a provided weblink or the company's website under Events and Presentation section.

Legend Biotech will present new minimal residual disease (MRD) negativity data from the Phase 3 CARTITUDE-4 trial at the 66th ASH Annual Meeting. The study evaluated CARVYKTI versus standard of care in lenalidomide-refractory multiple myeloma patients who received 1-3 prior therapies. The data shows significantly increased and sustained MRD negativity rates, supporting CARVYKTI as a transformative treatment option. CARVYKTI, the first BCMA-targeted CAR-T cell therapy approved for multiple myeloma after one prior line of therapy, is now available in five countries and has treated over 4,000 patients.

Legend Biotech (NASDAQ: LEGN) has appointed Alan Bash as President of CARVYKTI® in a newly created position. Bash will manage CARVYKTI's continued growth and oversee commercial, technical operations, and quality functions. The appointment follows CARVYKTI's recent FDA and European Commission approvals for label expansion. Bash brings extensive experience as former CEO of ZielBio and Checkmate Pharmaceuticals, plus a 23-year career at Bristol Myers Squibb where he led the U.S. launch of Opdivo® and expansion of other cancer treatments. CARVYKTI is currently the fastest launched CAR-T product on the market.

Legend Biotech (NASDAQ: LEGN) has announced it will host an investor conference call on Tuesday, November 12, 2024, at 8:00 am ET to discuss third-quarter 2024 financial results. Senior leadership will present the company's quarterly performance during the call. Investors can access the live audio webcast through a provided weblink, with a replay and earnings release available on the company's Investor Relations website approximately two hours after the call.

Legend Biotech (NASDAQ: LEGN) has announced plans to establish a new 31,000 square-foot state-of-the-art research and development facility in Philadelphia, Pennsylvania. This expansion aims to enhance Legend's cell therapy portfolio and expand its R&D capabilities as a global cell therapy leader. The facility, located at 2300 Market Street, is expected to be completed in the third quarter of 2025 and will eventually house 55 full-time employees.

This new site adds to Legend's existing global R&D organization, which includes over 350 employees worldwide. The company, with over 1,200 employees in the United States, views this expansion as an opportunity to join Philadelphia's growing biotech community, attract top talent, and strengthen partnerships with local research institutions.

Multiply Labs, a robotics company specializing in automated manufacturing systems for individualized drugs, has announced a collaboration with Legend Biotech (NASDAQ: LEGN). The partnership aims to apply advanced robotic technology to cell therapy manufacturing.

Multiply Labs' approach involves robotic systems that can operate various instruments already used in the cell and gene therapy industry, potentially enabling faster adoption of robotic technology. Legend Biotech will evaluate Multiply Labs' robotic technologies and secure priority access to these automated systems.

The collaboration's template is based on a peer-reviewed study published in Cytotherapy, which demonstrated statistical equivalence between manual and automated cell expansion processes. This initiative could lead to reduced labor costs and increased manufacturing throughput in the future.

Legend Biotech (NASDAQ: LEGN), a GenScript subsidiary, has received approval from China's NMPA for ciltacabtagene autoleucel (cilta-cel), a CAR-T therapy for relapsed or refractory multiple myeloma. This breakthrough treatment is approved for adult patients who have undergone at least three prior therapies. The approval is based on the CARTIFAN-1 clinical trial, which showed impressive results:

• 87.9% overall response rate
• 79.3% complete or stringent complete response
• 32.56 months median duration of response
• 30.13 months median progression-free survival

This milestone reinforces GenScript's commitment to innovation in cell therapy and strengthens its position in the biotech industry.