On June 30, 2025 Tyra Biosciences, Inc. (Tyra or the Company) reported the first patient has been dosed in the SURF302 Phase 2 clinical study of TYRA-300 in low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC) (Press release, Tyra Biosciences, JUN 30, 2025, View Source [SID1234654174]).

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SURF302 is an open-label Phase 2 clinical study evaluating the efficacy and safety of TYRA-300 in participants with FGFR3-altered low-grade, IR NMIBC. The study will enroll up to 90 participants at multiple sites primarily in the United States. Participants will be randomized initially to treatment with TYRA-300 at 50 mg once daily (QD) (Cohort 1) or treatment with TYRA-300 at 60 mg QD (Cohort 2). Following a review of efficacy and safety, an additional dosing cohort may be evaluated. The primary endpoint is complete response (CR) rate at three months. Secondary endpoints include time to recurrence, the median duration of response, recurrence free survival, progression free survival, safety and tolerability. The Company expects to report initial three-month CR data in the first half of 2026.

TYRA-300 will also be evaluated in pediatric achondroplasia in the BEACH301 Phase 2 study, which is open for enrollment and for which the Company now expects first child dosing in the second half of 2025.