Tyra Biosciences receives FDA clearance for Phase 2 trial of TYRA-300 in achondroplasia

Tyra Biosciences, Inc.

FDA cleared IND for TYRA-300 Phase 2 trial (BEACH301) in children with achondroplasia ages 3-10.
BEACH301 is multicenter, open-label, dose-escalation/dose-expansion with two cohorts (naïve and prior therapy), up to 10 per dose level.
Primary endpoints: safety/tolerability and annualized growth velocity; secondary: height z-score, proportionality, PK.
First patient dosing expected Q1 2025; also plans IND for TYRA-300 in NMIBC by year-end 2024.

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