02.02.2024 01:23:55

Tyra : FDA Grants Rare Pediatric Disease Designation To TYRA-300 For Achondroplasia Treatment

(RTTNews) - The U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation to TYRA-300, an oral FGFR3 selective inhibitor, for the treatment of achondroplasia, Tyra Biosciences Inc. (TYRA) said in a statement on Friday.

TYRA closed Thursday's regular trading at $13.01 down $0.39 or 2.91%. But in the after-hours trading the stock gained $0.39 or 3.00%.

Achondroplasia is the most common form of dwarfism with limited therapeutic options. People living with achondroplasia may experience severe skeletal complications including foramen magnum and spinal stenosis, hydrocephalus and sleep apnea. A specific DNA mutation in FGFR3 causes an estimated 99% of achondroplasia.

Tyra Biosciences noted that it plans to submit an Investigational New Drug application or IND to the FDA in the second half of 2024 for the initiation of a randomized Phase 2 clinical trial evaluating multiple dose cohorts of TYRA-300 for children with achondroplasia.

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