Tyra Bioscience (TYRA) has released an update.
Tyra Biosciences, Inc. announced that the FDA has granted Rare Pediatric Disease Designation to their drug TYRA-300, a treatment for achondroplasia. This designation is for drugs addressing serious conditions affecting fewer than 200,000 people in the U.S., primarily children under 18. If TYRA-300’s New Drug Application is successful, Tyra may receive a Priority Review Voucher, which expedites future drug approvals. The company plans to submit an IND for a Phase 2 trial of TYRA-300 in the latter half of 2024.
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For a comprehensive understanding of the announcement, you can read the full document here.