Tyra Biosciences Announces First Patient Dosed in SURF302 Phase 2 Study for Non-Muscle Invasive Bladder Cancer

Strategic Insights -

Tyra Biosciences, Inc. has announced the dosing of the first patient in the SURF302 Phase 2 clinical study for TYRA-300 in low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC). The study aims to evaluate the efficacy and safety of TYRA-300 in up to 90 participants at multiple sites in the United States.

Key Takeaways:

  • The SURF302 Phase 2 clinical study will evaluate the efficacy and safety of TYRA-300 in participants with FGFR3-altered low-grade, IR NMIBC.
  • The study will enroll up to 90 participants and will be conducted at multiple sites primarily in the United States.
  • Participants will be randomized to receive TYRA-300 at 50 mg or 60 mg once daily and will be evaluated for complete response rate, time to recurrence, median duration of response, recurrence-free survival, progression-free survival, and safety and tolerability.
  • The primary endpoint of the study is the complete response (CR) rate at three months.
  • 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.
  • The BEACH301 study is expected to start dosing in the second half of 2025.

Statistics:

  • Up to 90 participants will be enrolled in the SURF302 study.
  • The study will be conducted at multiple sites primarily in the United States.
  • The primary endpoint of the study is the complete response (CR) rate at three months.
  • 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.

Sources:

  • United States Securities and Exchange Commission (SEC), Washington, D.C. 20549.
  • FORM 8-K Current Report filed by Tyra Biosciences, Inc. on June 30, 2025.