Tyra Biosciences reports early Phase 2 bladder cancer data for dabogratinib, 60 mg dose chosen
Tyra Biosciences reported initial Phase 2 SURF302 results for oral dabogratinib in FGFR3-altered low-grade intermediate-risk non-muscle invasive bladder cancer, as of an August 31, 2026 data cutoff. The company selected 60 mg once daily as the potential dose for a planned registrational adjuvant program, with a registrational study expected to start in 2027, subject to health authority feedback. Results are early, based on 26 evaluable participants, and the company notes they may change with further follow-up.
Key points
- SURF302 3-month overall response rate was 79% (11/14) at 60 mg once daily and 67% (8/12) at 50 mg once daily
- Grade 3 treatment-emergent adverse events occurred in 14% (3 of 22) at 60 mg and 9% (2 of 22) at 50 mg; no Grade 4 or 5 events were reported
- The company plans to meet health authorities on Phase 3 design and dose selection and expects to start a registrational adjuvant study in 2027
- Company estimates an IR NMIBC market opportunity of greater than $5 billion, based on third-party market research and assumptions
The filing
Written by AI on Nov 9, 2026, 11:45 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 09, 2026.
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