regulatory
confidence high
sentiment positive
materiality 0.75
CHMP positive opinion for CASGEVY conditional EU approval in sickle cell and beta thalassemia
CRISPR Therapeutics AG
- EMA's CHMP adopted positive opinion for conditional approval of CASGEVY (exagamglogene autotemcel) for severe sickle cell disease and transfusion-dependent beta thalassemia.
- CASGEVY is a CRISPR/Cas9 gene-edited therapy jointly developed by CRISPR Therapeutics and Vertex Pharmaceuticals.
- European Commission decision expected in February 2024; conditional marketing authorizations are valid one year, renewable annually.