other material
confidence high
sentiment positive
materiality 0.85
Sangamo: Phase 3 hemophilia A gene therapy succeeds; share authorization suit resolved
SANGAMO THERAPEUTICS, INC
- Phase 3 AFFINE trial met primary endpoint: mean ABRtotal reduced from 4.73 (prophylaxis) to 1.24 post infusion (p=0.004).
- 84% of participants (42/50) achieved FVIII activity >5% at Month 15; 88% had no treated bleeds.
- Safety: no FVIII inhibitors, no treatment-related malignancies; ALT elevations manageable with corticosteroids.
- Delaware Court validated share increase vote standard; Sangamo dismissed Section 205 application.