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# Tyra Biosciences Gets Rare Pediatric Designation
- URL: https://www.fdaweb.com/tyra-biosciences-gets-rare-pediatric-designation/
- Published: 2024-02-02T12:00:00.000Z
- Updated: 2026-09-14T14:22:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156277

FDA has granted Tyra Biosciences a rare pediatric disease designation for TYRA-300, an oral FGFR3 selective inhibitor for treating achondroplasia, the most common form of dwarfism. “A specific DNA mutation in FGFR3 causes an estimated 99% of achondroplasia,” the company says. Tyra is planning to submit an IND in the second half of this year to begin a randomized Phase 2 clinical trial evaluating multiple dose cohorts of TYRA-300 for children with achondroplasia.TYRA-300 is also being evaluated in an oncology open label Phase 1/2 clinical study, SURF301, to determine the optimal dose for treating solid tumors, according to the company.