On October 28, 2024, Tyra Biosciences announced that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application for TYRA-300. This clearance permits the company to proceed with a Phase 2 clinical trial, designated BEACH301, for TYRA-300 in children with achondroplasia.
TYRA-300 is an investigational, oral, FGFR3-selective inhibitor designed to avoid toxicities associated with inhibiting other FGFR isoforms. The company expects to dose the first child with achondroplasia in the BEACH301 study during the first quarter of 2025.
This regulatory milestone follows the FDA's previous grants of Orphan Drug Designation in July 2023 and Rare Pediatric Designation in January 2024 for TYRA-300 in achondroplasia. The BEACH301 study will evaluate safety, tolerability, and changes in annualized growth velocity in children aged 3 to 10 with achondroplasia.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.