TYRA - Tyra Biosciences gets FDA orphan drug designation for dwarfism therapy
2023-08-01 10:23:02 ET
Tyra Biosciences ( NASDAQ: TYRA ) said that the US Food and Drug Administration has granted orphan drug status to its lead drug candidate TYRA-300 in the treatment of achondroplasia, the most common form of dwarfism.
The biotech company said it is preparing to file with the FDA to begin a Phase 2 clinical study of product in children in 2024.
The FDA generally defines an orphan drug as a product addressing a condition that affects fewer than 200,000 people in the US. The designation makes the drug potentially eligible for up to seven years of market exclusivity, if it is approved.
The company is expected to release its quarterly earnings report later this week.
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Tyra Biosciences gets FDA orphan drug designation for dwarfism therapy