Tyra Biosciences Gets FDA Orphan Designation for TYRA-300 in Achondroplasia
01 Agosto 2023 - 2:54PM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 01, 2023 08:39 ET (12:39 GMT)
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