Tyra Reports Phase 2 Dabogratinib Results in Bladder Cancer

San Diego, California, September 10, 2026

SURF302 Evaluates Oral FGFR Inhibition

The SURF302 Phase 2 study is designed to evaluate dabogratinib in patients with LG IR NMIBC whose tumors harbor qualifying FGFR3 alterations. These genetic alterations can drive abnormal signaling through the fibroblast growth factor receptor pathway and are associated with the development and progression of certain bladder cancers. Dabogratinib is an investigational, orally administered FGFR1, FGFR2 and FGFR3 inhibitor designed to selectively target FGFR signaling. Tyra developed the molecule using its proprietary SNÅP platform, which is intended to generate small-molecule therapies capable of addressing genetic alterations associated with cancer and other diseases. The SURF302 study is evaluating patients with recurrent LG IR NMIBC who have received prior standard treatments. The clinical program is particularly focused on patients with FGFR3 alterations, allowing investigators to evaluate whether molecular selection can identify patients most likely to benefit from targeted FGFR inhibition. NMIBC remains a significant clinical challenge because tumors can recur repeatedly even when they have not invaded the bladder muscle. Patients may therefore undergo repeated procedures and surveillance. An effective oral targeted treatment could potentially provide a less invasive therapeutic option for appropriately selected patients.

Initial Data Show Antitumor Activity

Tyra’s initial analysis showed encouraging clinical activity with dabogratinib in the evaluated patient population. The company reported that treatment produced tumor responses in patients with FGFR3 alterations, supporting continued development of the investigational therapy. The findings are particularly relevant because LG IR NMIBC represents a patient population where treatment options have historically included bladder-directed therapies and repeated surgical procedures. The emergence of molecularly targeted therapies could provide an alternative approach for patients whose tumors contain actionable genomic alterations. The company is continuing to collect data from the ongoing SURF302 study. Additional follow-up will be required to determine the durability of responses, recurrence patterns and longer-term safety profile associated with dabogratinib. As an investigational therapy, dabogratinib should not be described as an approved treatment for bladder cancer. The current findings represent an early clinical assessment, and additional data will be required before regulatory authorities can determine whether the therapy’s benefit-risk profile supports approval.

Dabogratinib Advances Targeted Bladder Cancer Strategy

The development of dabogratinib reflects a broader shift toward precision oncology, in which treatments are selected according to molecular characteristics of individual tumors. By targeting FGFR3 signaling, Tyra is seeking to address a defined biological driver in a subset of bladder cancer patients. The company describes dabogratinib as potentially representing the first oral targeted innovation for patients with LG IR NMIBC. Its oral administration could offer a practical advantage compared with therapies that require intravesical administration or repeated procedures, although comparative benefits will ultimately need to be established through clinical evidence. Tyra’s broader oncology pipeline is focused on targeted therapies against clinically important genetic alterations. The company’s SNÅP platform is designed to discover and develop small molecules with differentiated selectivity and pharmacological properties. The initial SURF302 results therefore represent an important milestone for Tyra’s bladder cancer program. Continued enrollment, follow-up and data analysis will help clarify the magnitude and durability of dabogratinib’s clinical activity and establish the therapy’s potential role in the treatment sequence for FGFR3-altered LG IR NMIBC. Further development will also depend on regulatory discussions and the generation of mature clinical data. If the early findings are confirmed in larger and longer-term analyses, dabogratinib could become an important investigational option for patients seeking an oral targeted therapy for recurrent non-muscle-invasive bladder cancer. For the pharmaceutical sector, the program highlights the growing role of genomic biomarkers and targeted small-molecule therapies in cancers traditionally managed through repeated local interventions. Tyra’s ongoing clinical work will determine whether dabogratinib can translate its molecularly targeted mechanism into durable clinical benefit for patients with FGFR3-altered bladder tumors.

Source: Tyra Biosciences press release