regulatory
confidence high
sentiment positive
materiality 0.60
FDA grants Rare Pediatric Disease Designation to Tyra Biosciences' TYRA-300 for achondroplasia
Tyra Biosciences, Inc.
- FDA granted Rare Pediatric Disease Designation to TYRA-300, an oral FGFR3 inhibitor, for achondroplasia.
- If NDA approved, Tyra may receive a Priority Review Voucher (PRV) that can be sold or transferred.
- Company plans to submit IND in H2 2024 for a randomized Phase 2 trial in children with achondroplasia.
- RPD Designation is for diseases affecting <200,000 in US and primarily individuals under 18 years.