Tyra Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead precision medicine program, TYRA-300, for the treatment of achondroplasia. The FDA's Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended for treatment, diagnosis or prevention of rare diseases and conditions that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides certain benefits, including tax credits for qualified clinical trials andemption from certain user fees to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval. TYRA-300 is being evaluated in a multi-center, open label Phase 1/2 clinical study, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors).

In skeletal dysplasias, TYRA-300 has demonstrated positive preclinical results and the Company expects to submit an IND for the initiation of a Phase 2 clinical study in pediatric achondroplasia in 2024.