Tyra reports first Phase 2 SURF302 data for dabogratinib in bladder cancer

Tyra Biosciences reported quarterly results on November 10, 2026, highlighted by initial data from its Phase 2 SURF302 study of oral dabogratinib in patients with FGFR3-altered low-grade intermediate-risk non-muscle invasive bladder cancer (IR NMIBC). The company said that in September 2026, TYRA reported initial results from SURF302 (data cutoff as of August 31, 2026), its Phase 2 ablative study evaluating oral dabogratinib in patients with FGFR3-altered low-grade IR NMIBC.¹

At the 60 mg once-daily dose, oral dabogratinib demonstrated a 79% overall response rate and a 64% best overall response complete response rate among participants with single and multiple marker lesions, in a group of 14 patients.¹ In the subgroup with a single marker lesion, among 8 participants, the 60 mg dose showed a 100% overall response rate and a 75% complete response rate, which the company said supports its planned Phase 3 adjuvant strategy.¹ Safety results across both dose cohorts, covering 44 patients, were described as favorable, and no clinically significant hyperphosphatemia, nail toxicity, or ocular toxicity was reported, and there were no Grade 3 treatment-related adverse events at the 60 mg dose.¹ Tyra has finished enrolling the 60 mg cohort and is now enrolling patients at 70 mg once daily to further study the drug in the ablative setting.¹

The company is also moving toward late-stage development, saying it is preparing for engagement with health authorities on the design of a Phase 3 adjuvant study, with initiation expected in 2027 pending regulatory feedback.¹ In its companion trial, SURF303, the first treated participant achieved a complete response at the 3-month assessment on the 60 mg dose, with no treatment-emergent adverse events observed as of the August 31, 2026 cutoff.¹ In the achondroplasia program, BEACH301, the study has advanced through five dose levels in its safety sentinel cohort, and based on favorable safety data to date, the Data Safety Monitoring Committee authorized opening a sixth dose level testing 0.875 mg/kg.¹ Initial results from that cohort, including six-month annualized height velocity and safety data for roughly 25 children, are expected in 2027.¹

On financing, Tyra completed an underwritten public offering of common stock and pre-funded warrants in September 2026, raising about $400 million in gross proceeds before fees, led by RA Capital Management with participation from other institutional investors.¹ As of September 30, 2026, the company held cash, cash equivalents and marketable securities of $700.5 million, which it said is expected to fund planned operations through 2030.¹