TYRA-300

H.C. Wainwright analyst Mitchell Kapoor reiterates a Buy rating for Tyra Bioscience, citing FDA clearance for TYRA-300 Phase 2 trial and promising clinical data in non-muscle-invasive bladder cancer, with a 12-month price target of $30 per share.

The FDA has cleared Tyra Biosciences' IND application for TYRA-300, allowing a Phase 2 trial in low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC).

The Food and Drug Administration (FDA) continues to oversee the approval process for new products, drugs, therapies, and treatments, with updates on applications, safety alerts, and more.

Tyra Biosciences reported positive interim Phase 1/2 data for TYRA-300 in metastatic urothelial cancer (mUC), with a 54.5% confirmed partial response rate in FGFR3+ patients.

A new multicenter Phase 1/2 clinical trial (SURF-301) is investigating TYRA-300, an oral FGFR inhibitor, in patients with advanced urothelial carcinoma harboring FGFR3 mutations. The study aims to determine the optimal dosing and safety profile of this targeted therapy, potentially offering a new treatment option for bladder cancer patients with specific genetic alterations.