Tyra Bioscience Cleared by FDA to Conduct Phase 2 Study in Pediatric Achondroplasia

MT Newswires Live10-28

Tyra Bioscience (TYRA) said Monday that the US Food and Drug Administration cleared its Investigational New Drug application for TYRA-300 to treat children with achondroplasia.

The company said the clearance paves the way for a phase 2 study to assess the safety and tolerability of TYRA-300 as well as evaluate changes in annualized growth velocity to determine dosages in children with achondroplasia aged 3 to 10. The first participant is expected to be dosed in Q1 next year, the company added.

Tyra also said it is planning assessments of changes in the spine and quality of life measures. Achondroplasia is a common form of dwarfism affecting 1 in 15,000 to 40,000 children, according to Tyra.

Shares of the company were up more than 3% in recent Monday premarket activity.

Price: 22.77, Change: +0.84, Percent Change: +3.83

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