regulatory
confidence high
sentiment positive
materiality 0.55
Kiora Pharma receives EU orphan designation for KIO-301 in inherited retinal dystrophies
KIORA PHARMACEUTICALS INC
- EMA grants Orphan Medicinal Product Designation for KIO-301 in non-syndromic rod-dominant retinal dystrophies including retinitis pigmentosa.
- Provides at least 10 years of market exclusivity in Europe, reduced fees, centralized approval, and EMA scientific advice.
- KIO-301 already has US Orphan Drug Designation; Phase 2 ABACUS-2 trial expected to initiate later in 2024.
- KIO-301 is a small molecule photoswitch designed to restore light sensing in degenerated retinas, a non-gene therapy approach.
- Co-development and commercialization partner Théa Open Innovation covers ex-Asia territories.