Tyra Biosciences Gets FDA Orphan Designation for TYRA-300 in Achondroplasia

By Colin Kellaher

Tyra Biosciences has won a key U.S. Food and Drug Administration designation for its lead precision-medicine program targeting the most common form of dwarfism.

The Carlsbad, Calif., clinical-stage biotechnology company on Tuesday said the FDA granted orphan-drug designation to TYRA-300 for the treatment of achondroplasia, which currently has limited therapeutic options.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing exclusivity period against competition.

Tyra said people living with achondroplasia may experience severe skeletal complications, including cranial and spinal stenosis, hydrocephalus and sleep apnea.

The company said it is on track to seek FDA approval of a Phase 2 study of TYRA-300 in pediatric achondroplasia in 2024.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

August 01, 2023 08:39 ET (12:39 GMT)

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