regulatory
confidence high
sentiment positive
materiality 0.85
CRISPR Therapeutics' CASGEVY receives EU conditional approval for sickle cell disease and beta thalassemia
CRISPR Therapeutics AG
- European Commission granted conditional marketing authorization for CASGEVY (exa-cel).
- Indicated for patients 12+ with severe sickle cell disease or transfusion-dependent beta thalassemia.
- Eligible when HSCT is appropriate and no HLA-matched related donor is available.
- CMA valid for one year, renewable annually with ongoing data review.
- CASGEVY is a CRISPR/Cas9 gene-edited therapy jointly developed with Vertex.