Strong efficacy and safety data de-risk dabogratinib's registrational path in NMIBC and support expansion into LG UTUC and achondroplasia. Monitor upcoming data from the 70 mg cohort, FDA interactions, and initiation of the Phase 3 adjuvant study in 2027. Positive readthrough for TYRA's FGFR3 franchise value.
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Executive Summary
Tyra Biosciences announced positive initial Phase 2 data for oral dabogratinib in FGFR3-altered low-grade intermediate-risk NMIBC, showing 79% ORR and 64% complete response rate at 60 mg QD with favorable safety (no Grade 4/5 AEs, no dose reductions). The company plans to initiate a registrational adjuvant study in 2027, targeting a >$5B market opportunity.
Key Facts
- SURF302 Phase 2 ORR 79% (11/14) at 60 mg QD at 3-month and best overall response; CR 64% (9/14) BOR
- No Grade 4 or 5 treatment-emergent adverse events; Grade 3 TEAEs in 14% at 60 mg; none at 60 mg were treatment-related
- Plans to complete 60 mg enrollment, initiate 70 mg cohort, engage health authorities on Phase 3 design, and start registrational adjuvant study in 2027
- SURF303 first LG UTUC patient achieved CR at 3 months with no TEAEs; BEACH301 cleared fifth dose level in achondroplasia cohort
- Estimated total market opportunity for IR NMIBC >$5 billion per third-party market research
Financial Impact
Market opportunity >$5 billion for IR NMIBC; no revenue or financial data reported
Risk Factors
- Initial clinical data may change as more patients are enrolled and follow-up matures
- Regulatory path and dose selection require alignment with FDA — no guarantee of approval
- Pre-revenue company with cash burn risk and potential future dilution
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 4 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-385886 |
| Document: 0001193125-26-385886-index-headers.html | 0001193125-26-385886 |
| Document: 0001193125-26-385886-index.html | 0001193125-26-385886 |
| Document: 0001193125-26-385886.txt | 0001193125-26-385886 |
Track record builds as more directional reports settle.
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Sep 14, 2026 18d ago | S-3ASR | $25.07 $25.65 | ▲ +2.31% | ▲ +2.21% | $20.50 (−18.21%) |
Sep 9, 2026 23d ago | 8-K | $22.01 $24.35 | ▲ +10.63% | ▲ +11.73% | $20.50 (−6.84%) |
Aug 4, 2026 8w ago | 424B5 | $25.71 $25.30 | ▲ +1.59% | ▲ +1.95% | $20.50 (+20.25%) |
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Apr 17, 2026 24w ago | 8-K | $35.56 $37.59 | ▲ +5.71% | ▲ +5.15% | $20.50 (−42.34%) |
Apr 13, 2026 24w ago | 144 | $35.27 $36.69 | ▲ +4.03% | ▲ +2.63% | $20.50 (−41.86%) |
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