James Shin

Leonid Timashev

Mitchell Kapoor

Yaron Werber

Ashwani Verma

George Farmer

Jessica Fye

Jonathan Miller

Justin Zelin

Kelly Shi

Sean McCutcheon

Vikram Purohit

Gena Wang

Konstantinos Biliouris

Kostas Biliouris

Rick Bienkowski

Dingding Shi

Gena Huidong Wang

Huidong Wang

Jeet Mukherjee

Prem Lachman

Terence Flynn

Umer Raffat

Ziyi Chen

- Legend Biotech Corporation announced on **October 10, 2025**, that the **U.S. Food and Drug Administration (FDA)** approved a label update for its CAR-T cell therapy, **CARVYKTI®**.  **[1801198_0001171843-25-006414_f6k_101025.htm:0]** 
- The label update includes **overall survival (OS) data** from the **Phase 3 CARTITUDE-4 study**, demonstrating a **statistically significant improvement in OS** for CARVYKTI in patients with relapsed, refractory multiple myeloma after one to three prior lines of therapy.  **[1801198_0001171843-25-006414_f6k_101025.htm:0]** 
- The updated label also adds **immune effector cell-associated enterocolitis (IEC-EC)** to Boxed Warnings and Warnings and Precautions, noting its potential for severe manifestations and **fatal outcomes**.  **[1801198_0001171843-25-006414_f6k_101025.htm:0]** 
- Additionally, **reactivation of John Cunningham (JC) virus**, leading to **progressive multifocal leukoencephalopathy (PML)**, was added to Warnings and Precautions and Postmarketing Experience, including cases with **fatal outcomes**.  **[1801198_0001171843-25-006414_f6k_101025.htm:0]**

Legend Biotech Announces FDA Approval for CARVYKTI Label Update with Overall Survival Data and Safety Warnings

- Legend Biotech Corporation announced preliminary net trade sales for its product **CARVYKTI®** for the quarter ended **September 30, 2025**.  **[1801198_0001171843-25-006413_f6k_101425.htm:1]** 
- CARVYKTI® generated approximately **$524 million** in net trade sales during this quarter.  **[1801198_0001171843-25-006413_f6k_101425.htm:1]** 
- The sales figure is based on information provided to Legend Biotech by Janssen and has not been independently verified or audited by Legend Biotech's independent registered public accountants.  **[1801198_0001171843-25-006413_f6k_101425.htm:1]**

Legend Biotech Announces Preliminary CARVYKTI Sales for Q3 2025

- On **October 6, 2025**, Legend Biotech USA Inc., a wholly-owned subsidiary of Legend Biotech Corporation, entered into a **Component and Product Supply Agreement** with Janssen Pharmaceuticals, Inc.  **[1801198_0001171843-25-006329_f6k_100725.htm:1]** 
- Under this agreement, Legend Biotech will **manufacture and supply** ciltacabtagene autoleucel (cilta-cel) for clinical and commercial use globally, excluding Greater China, from their GMP manufacturing facility in Raritan, New Jersey.  **[1801198_0001171843-25-006329_f6k_100725.htm:1]** 
- Janssen will pay Legend Biotech a transfer price based on total production costs plus a specified markup, with the **costs for commercial and clinical supply ultimately shared equally** by both companies as "Allowable Expenses" and "Development Costs" under their existing Collaboration Agreement.  **[1801198_0001171843-25-006329_f6k_100725.htm:1]** 
- This new agreement **supersedes** the Interim Product Supply Agreement signed by Legend Biotech and Janssen on February 28, 2022.  **[1801198_0001171843-25-006329_f6k_100725.htm:1]**

Legend Biotech USA Enters Supply Agreement with Janssen Pharmaceuticals

Legend Biotech (LEGN)