The United States Food and Drug Administration (FDA) has awarded the Rare Pediatric Disease Designation to TYRA-300, a drug specifically designed to inhibit FGFR3. This drug, produced by Tyra Biosciences Inc., is intended to treat achondroplasia, according to the company's recent announcement.
Tyra Biosciences, which saw its stock fall by 2.91% or $0.39 to close at $13.01 on Thursday, experience a slight surge in after-hour trading, gaining $0.39 or 3.00%.
Achondroplasia, a condition that represents the most prevalent form of dwarfism, currently offers limited therapy alternatives. Individuals suffering from this condition are prone to severe skeletal complications such as foramen magnum and spinal stenosis, hydrocephalus, and sleep apnea. Notably, 99% of achondroplasia cases can be linked to a particular DNA mutation in FGFR3.
The company also detailed its plans to forward an Investigational New Drug (IND) application to the FDA in the latter half of 2024. This seeks to start a randomized Phase 2 clinical trial that will evaluate the different dosage cohorts of TYRA-300 for children affected by achondroplasia.
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