Tyra Biosciences reported third-quarter 2026 results and clinical progress for dabogratinib, its investigational oral drug targeting FGFR3. The company highlighted early results in bladder cancer, progress in two other clinical programs and a completed $400 million stock-and-warrant financing.
Tyra said it had $700.5 million in cash, cash equivalents and marketable securities at September 30, enough to fund operations through 2030, according to the company. The financing is intended to support its plan to advance dabogratinib across three development programs.
Dabogratinib clinical programs
- Bladder cancer (SURF302): In a Phase 2 study of patients with FGFR3-altered, low-grade intermediate-risk non-muscle-invasive bladder cancer, the 60-mg once-daily dose produced an overall response rate of 79% and a complete-response rate of 64% among 14 participants with single or multiple marker lesions.
- In the subgroup with a single marker lesion, eight participants had a 100% overall response rate and a 75% complete-response rate. Tyra said these results support its planned Phase 3 adjuvant strategy; the reported study results came from the ablative setting.
- Tyra reported favorable initial safety and tolerability across both dose cohorts, which together included 44 participants. It said there were no clinically significant cases of hyperphosphatemia, nail toxicity or ocular toxicity, and no Grade 3 treatment-related adverse events at 60 mg.
- Enrollment in the 60-mg cohort is complete, and Tyra is enrolling a 70-mg cohort to further assess dabogratinib in the ablative setting. The company is preparing to discuss a Phase 3 adjuvant study with health authorities and expects to start it in 2027, subject to regulatory feedback.
- Upper-tract urothelial cancer (SURF303): The first participant treated in this Phase 2 study had a complete response at the three-month assessment on 60 mg once daily. Tyra reported no treatment-emergent adverse events for that participant as of the August 31 data cutoff. The company is continuing enrollment and expects to report more results in 2027.
- Achondroplasia (BEACH301): The Phase 2 study in children ages 3 to 10 has advanced through five dose levels in its safety sentinel cohort. After reviewing safety data, the monitoring committee authorized a sixth level, testing 0.875 mg/kg. Tyra expects to report initial safety and six-month annualized height-velocity results in 2027, covering about 25 children in total.
Financing and financial position
- Tyra completed a public offering in September that raised about $400 million in gross proceeds, before discounts, commissions and other offering expenses. The offering included common stock and pre-funded warrants and was led by RA Capital Management, with participation from new and existing institutional investors.
- The company said the financing strengthens its ability to advance dabogratinib’s three-program strategy through later-stage development. Its stated cash runway through 2030 is based on the $700.5 million held at September 30.
The bladder-cancer findings are early results from a relatively small group, and the planned Phase 3 study remains subject to discussions with regulators. The financing and reported cash balance provide Tyra with substantial capital to pursue its three programs: low-grade intermediate-risk bladder cancer, low-grade upper-tract urothelial cancer and achondroplasia.