Tyra Biosciences (TYRA) said Friday it obtained investigational new drug clearance from the US Food and Drug Administration for TYRA-300, moving to a phase 2 trial of the potential drug for non-muscle invasive bladder cancer.
The phase 2 SURF302 trial targets to enroll up to 90 participants at several sites mainly in the US. Patient dosing is expected to begin in Q2, followed by the initial three-month complete response data, which is the study's primary endpoint, the company said.
TYRA-300 is also set to be evaluated in other phase 2 studies -- BEACH301 for pediatric achondroplasia and SURF301 for metastatic urothelial carcinoma, the company added.
Shares of the company were down nearly 5% in recent trading.
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