Tyra Bioscience Gains Pediatric Disease Designation for Achondroplasia Drug Amid FDA Voucher Uncertainty

Tyra Bioscience, Inc (TYRA) has disclosed a new risk, in the Regulation category.

Tyra Bioscience, Inc. has achieved a rare pediatric disease designation for its drug TYRA-300, aimed at treating achondroplasia, yet this does not ensure the receipt of a coveted FDA priority review voucher upon the drug’s approval. The FDA’s stringent criteria for voucher eligibility entail that even if TYRA-300 secures approval, it might be disqualified for reasons such as previous approval of active ingredients or lack of pediatric-focused clinical data. Moreover, looming legislative deadlines pose an additional risk, with the program set to sunset after September 30, 2024, potentially leaving Tyra Bioscience with limited time to capitalize on the designation and secure the voucher, which can significantly expedite the review process for subsequent products.

The average TYRA stock price target is $22.75, implying 30.97% upside potential.

To learn more about Tyra Bioscience, Inc’s risk factors, click here.