Tyra Biosciences, Inc. (NASDAQ:TYRA) reported initial Phase 2 SURF302 results on September 9 for dabogratinib, an investigational oral FGFR3 inhibitor. The study enrolled patients with FGFR3-altered low-grade, intermediate-risk non-muscle-invasive bladder cancer.
At the August 31, 2026 cutoff, 14 participants receiving 60 mg once daily had received treatment and completed at least the three-month disease assessment, qualifying for the efficacy analysis. The safety group at this dose included 22 participants. The three-month objective response rate (ORR), including complete and partial responses, was 79%, or 11 of 14 participants. The three-month complete response (CR) rate, the trial’s primary endpoint, was 57%, or eight of 14 participants.
Bull Case
For Tyra Biosciences, Inc., the opportunity is to offer treatment that patients can take orally, potentially reducing the burden associated with repeated catheter-based administration. Convenience could support adoption if the drug delivers meaningful recurrence prevention with manageable toxicity.
There was evidence of responses deepening. The best overall CR rate at 60 mg reached 64%, or nine of 14 participants, after one partial response at three months became a complete response at six months.
The eight participants with a single marker lesion all responded. Their CR rate was 63% at three months and 75% as best overall response. Management sees this lower-tumor-burden group as relevant to the proposed adjuvant setting, where treatment follows tumor removal.
Safety also supports further evaluation. Among 22 participants assessed at 60 mg, there were no Grade 4 or 5 treatment-emergent adverse events, dose reductions, or treatment-related discontinuations. That is encouraging for a strategy that could require sustained dosing.
Bear Case
The central uncertainty is whether activity against visible tumors predicts prevention of future recurrences. Even a single remaining lesion differs from an adjuvant setting with no tumor left behind. The eight-patient subgroup provides a development hypothesis, but limited evidence for the eventual treatment population.
The early, open-label dataset cannot establish superiority over existing care. All five three-month complete responders with available six-month assessments maintained their responses. Larger samples and longer follow-up are still needed to establish durable disease control and recurrence prevention.
Safety needs a similar perspective. Three of the 22 participants at 60 mg experienced Grade 3 treatment-emergent adverse events, although no Grade 3 treatment-related events were reported. A larger population and longer exposure will better establish tolerability for ongoing treatment.
Tyra Biosciences, Inc. plans to complete enrollment at 60 mg and explore 70 mg for the setting in which treatment targets existing tumors. It also plans health-authority discussions on Phase 3 design and dose selection. Higher dosing could improve activity, but its benefit must justify any additional toxicity.
Hedge Fund Sentiment
The filings available so far reflect positions held before Tyra Biosciences, Inc. reported initial Phase 2 SURF302 results. Insider Monkey’s database showed 38 hedge funds holding Tyra Biosciences, Inc. at the end of 2Q2026, down from 40 funds three months earlier.
Conclusion
Tyra Biosciences, Inc. has a rationale for continued development, while the adjuvant strategy still needs prospective validation. Mature response durability, evidence of reduced recurrence, and regulatory agreement on the Phase 3 endpoint and dose will determine whether early activity translates into a commercially useful treatment.
READ NEXT: Vertiv (VRT) Signed a Deal Worth Up to $2.6B for UtilityInnovation. Can Faster Power Deployment Justify the Contingent Consideration? and Asana (ASAN) Reached a 10% Non-GAAP Operating Margin. Can Agentic Products Restore Expansion?
This article is originally published at Insider Monkey.
Hedge Fund Resource Center