Tyra Biosciences Reports 79% ORR in Phase 2 SURF302 for Oral Dabogratinib in Bladder Cancer
TYRA sits 90% above its 52-week low of $11.703.
Summary
Tyra Biosciences reported positive Phase 2 SURF302 data for oral dabogratinib in bladder cancer, with 79% ORR at 60 mg QD and a clean safety profile, supporting a planned registrational adjuvant study in 2027.
Key Events · Product Development and Regulatory · TYRA
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Phase 2 SURF302 Efficacy Results
79% ORR (11/14) at 60 mg QD and 67% ORR (8/12) at 50 mg QD in FGFR3-altered LG IR NMIBC; 64% best overall complete response rate at 60 mg.
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Favorable Safety Profile
No Grade 4/5 TEAEs, no dose reductions or treatment-related discontinuations at 60 mg QD; Grade 3 treatment-related AEs in only 2 of 44 participants (4.5%).
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Dose Selection and Registrational Path
Exposure-response analysis supports 60 mg QD for adjuvant setting; company plans to engage health authorities on Phase 3 design and initiate registrational adjuvant study in 2027.
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SURF303 and BEACH301 Updates
First SURF303 patient (LG UTUC) achieved complete response at 3-month assessment; BEACH301 cleared fifth dose level with no safety signals in pediatric achondroplasia cohort.
Analysis · TYRA · Life Sciences
Tyra Biosciences announced initial Phase 2 SURF302 results showing a 79% overall response rate (11/14) at the 60 mg once-daily dose of oral dabogratinib in FGFR3-altered low-grade intermediate-risk non-muscle invasive bladder cancer. The safety profile was clean — no Grade 4/5 adverse events, no dose reductions or treatment-related discontinuations at the selected dose. This is clinical proof of concept for selective oral FGFR3 inhibition and de-risks the planned registrational adjuvant study expected to start in 2027. The company also reported a complete response in the first SURF303 patient and cleared the fifth dose level in the pediatric BEACH301 study. Against a $1.6 billion market cap, positive Phase 2 data in a >$5 billion market opportunity is a meaningful value inflection.
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At the time of this filing, TYRA was trading at $22.22 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.6B. The 52-week trading range was $11.70 to $40.65. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.