Vertex Unveils Positive CASGEVY Data in Children and Plans Global Submissions

Reuters
12/06
Vertex Unveils Positive CASGEVY Data in Children and Plans Global Submissions

Vertex Pharmaceuticals Incorporated has announced new clinical data on CASGEVY® (exagamglogene autotemcel) in children aged 5-11 years with severe sickle cell disease or transfusion-dependent beta thalassemia. The data, which were presented at the American Society of Hematology $(ASH)$ Annual Meeting, are the first-ever clinical results for any genetic therapy in this age group. The efficacy and safety outcomes in children aged 5-11 years were consistent with previously established data in patients aged 12 years and older. Vertex reported that enrollment and dosing for the 5-11 years cohort are complete, and the company plans to initiate global regulatory submissions, including a supplemental Biologics License Application in the U.S., in the first half of 2026. CASGEVY is currently approved for eligible patients aged 12 years and older in multiple countries.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Vertex Pharmaceuticals Incorporated published the original content used to generate this news brief via Business Wire (Ref. ID: 20251206256152) on December 06, 2025, and is solely responsible for the information contained therein.

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