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Tyra Biosciences, Inc. (NASDAQ: TYRA) shares decreased in price Friday. The Carlsbad, Calif.-based Tyra, a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, announced today that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application for TYRA-300 allowing the company to proceed with a Phase 2 clinical trial of TYRA-300 in low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC).
This program will be led by newly appointed Dr. Erik Goluboff, SVP, Clinical Development of TYRA, who brings more than 30 years of experience as an academic urologic oncologist, principal investigator, practicing urologist and most recently Principal Medical Lead for GU/GI cancers at Genentech/Roche.
TYRA-300 is a potential first-in-class, investigational, oral, FGFR3-selective inhibitor designed to avoid the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while being agnostic for the FGFR3 gatekeeper mutations. FGFR3 is the most frequently altered gene in NMIBC, with 60-80% of IR NMIBC showing alterations. TYRA-300 is expected to be evaluated in three Phase 2 studies: SURF302 for IR NMIBC, BEACH301 for pediatric achondroplasia (ACH) and SURF301 for metastatic urothelial carcinoma (mUC).
TYRA shares fell 35 cents, or 2.2%, to $15.62.
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