dabogratinib (TYRA-300) / Tyra Biosci - LARVOL DELTA

Initial observation from SURF303 in LG UTUC (PRNewswire) - "In SURF303, TYRA's Phase 2 study evaluating oral dabogratinib in patients with low-grade upper tract urothelial cancer (LG UTUC), the first patient treated achieved a complete response at the 3-month assessment with 60 mg QD, with no observed TEAEs and remained on study drug as of the August 31, 2026 data cutoff."

P2 data • Urothelial Cancer

Tyra Biosciences Reports Initial Phase 2 SURF302 Results Supporting the First Potential Oral Innovation in LG IR NMIBC with Dabogratinib (PRNewswire) - "Initial efficacy results. As of the August 31, 2026 data cutoff, 26 participants were evaluable for efficacy across the 60 mg QD (n=14) and 50 mg QD (n=12) cohorts (participants who received study treatment and had undergone at least the month 3 disease assessment). All responses below are subject to change with continued treatment and follow-up....TYRA plans to complete enrollment in the 60 mg QD cohort and initiate a 70 mg QD cohort to explore dabogratinib in the ablative setting. TYRA also plans to engage health authorities on Phase 3 study design and dose selection and, subject to that feedback, to continue preparations for a planned registrational adjuvant study."

Clinical protocol • P2 data • Trial status • Bladder Cancer

Prenatal Treatment with Dabogratinib Increases Both Long Bones and Size of the Foramen Magnum and Delays Premature Fusion of Synchondroses in a Mouse Model Mimicking Achondroplasia (ESPE 2026) - No abstract available

Late-breaking abstract • Preclinical • Genetic Disorders

Systematic Analysis of Stromal-Epithelial Crosstalk Reveals the FGF21-FGFR3 Axis as a Key Driver of Corneal Wound Healing. (PubMed, Invest Ophthalmol Vis Sci) - "FGF21 stimulated ERK/AKT phosphorylation, promoted wound healing and proliferation, affects that were blunted by dabogratinib or FGFR3 knockdown and rescued by FGFR3 re‑expression...Our study revealed a novel interaction between CSCs and CEpCs mediated by the FGF21-FGFR3 axis. Exogenous FGF21 promotes the wound healing of CEpCs, suggesting a promising novel therapeutic strategy for corneal epithelial repair."

Journal • FGF21 • FGFR3

A Phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Participants with FGFR3-Altered Low-Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302) (AUA 2026) - P2 | "Recently, several pan-FGFR inhibitors have received FDA approval across multiple cancers, including erdafitinib in advanced urothelial carcinoma. Two doses will be tested (60 and 50 mg QD, n = 30 each) in a randomized 1:1 fashion, with the potential to test a third dose if necessary. The study is planned for approximately 51 centers in North America, Australia, and Europe."

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • FGFR1 • FGFR2 • FGFR3 • FGFR4

Preliminary safety and anti-tumor activity of TYRA-300, a highly selective FGFR3 inhibitor, in participants with advanced solid tumors with activating FGFR3 mutations/fusions (SURF301) (EORTC-NCI-AACR 2024) - P1/2 | "Early anti-tumor activity and safety data supports the continuing development of TYRA-300 for mUC and other solid tumors. The Phase 1 portion is still ongoing with the optimal dose not yet determined."

Clinical • Late-breaking abstract • Metastases • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • FGFR1 • FGFR3

Tyra Biosciences…announced the pricing of an underwritten offering of 9,079,000 shares of its common stock at a price of $22.03 per share and, in lieu of shares of common stock to certain investors, pre-funded warrants to purchase 9,078,529 shares of common stock at a purchase price of $22.029 per share… (PRNewswire) - "The gross proceeds to Tyra from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $400.0 million....TYRA intends to use the net proceeds from this offering, together with its existing cash, cash equivalents and marketable securities, to advance its 'dabogratinib 3x3' development strategy in low-grade upper tract urothelial carcinoma (LG-UTUC), intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) and achondroplasia (ACH), as well as to support its preclinical and drug discovery programs, working capital and other general corporate purposes."

Financing • Bladder Cancer • Genetic Disorders • Urothelial Cancer

A Phase 2A/B, Multi center, Open Label Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Participants with Low Grade Upper Tract Urothelial Carcinoma (SURF303) (EAU 2026) - No abstract available

Clinical • P2a data • Oncology • Solid Tumor • Urothelial Cancer

Prenatal Treatment with Dabogratinib Increases Both Long Bones and Size of the Foramen Magnum and Delays Premature Fusion of Synchondroses in a Mouse Model Mimicking Achondroplasia (ASBMR 2026) - No abstract available

Preclinical • Genetic Disorders

A Multicenter, Phase 2, Dose-Escalation/Dose-Expansion Study of Dabogratinib (formerly TYRA-300) in Children with Achondroplasia with Open Growth Plates: BEACH301 (ASBMR 2026) - No abstract available

Clinical • P2 data • Genetic Disorders

A Multicenter, Phase 2, Dose-Escalation/Dose-Expansion Study of Dabogratinib (Formerly TYRA-300) in Children with Achondroplasia with Open Growth Plates: BEACH301 (ENDO 2026) - "Conclusions BEACH301 is designed to establish the safety profile and identify dose(s) of dabogratinib with clinical improvements in growth parameters in children with ACH. The inclusion of dose escalation guided by safety, treatment-naïve and treatment-experienced cohorts, and comprehensive PK, anthropometric and imaging assessments provide a robust framework to support optimal dose selection in late-stage clinical studies of dabogratinib."

Clinical • P2 data • Genetic Disorders • Orthopedics • FGFR3

TYR300-203: A study to investigate dabogratinib (TYRA-300) in participants with Low Grade Upper Tract Urothelial Carcinoma (clinicaltrialsregister.eu) - P1/2 | N=12 | Not yet recruiting | Sponsor: Tyra Biosciences Inc.

New P1/2 trial • Oncology • Solid Tumor • Urothelial Cancer

TYR300-101: A Multicenter, Open-label Phase 1/2 Study of TYRA 300 in Advanced Urothelial Carcinoma and Other Solid Tumors (clinicaltrialsregister.eu) - P1/2 | N=75 | Completed | Sponsor: Tyra Biosciences Inc. | Suspended ➔ Completed

Trial completion • Oncology • Solid Tumor • Urothelial Cancer

GSC000829, a novel selective FGFR2/3 inhibitor, displays superior antitumor activity in preclinical FGFR-driven neoplasms models (AACR 2025) - "It also demonstrates enhanced antitumor activity at lower dosage in FGFR3-driven CDX models compared to the pan-FGFR inhibitor Erdafitinib, as well as other FGFR3-selective inhibitors such as TYRA300 and LOXO-435. GSC000829 exhibits favorable physicochemical and pharmacokinetic properties along with an excellent preclinical toxicity profile with no obvious phosphate increase at quite high exposure level in rats. Taken together, these findings bolster the rationale for advancing GSC000829 into clinical trials as a potential best-in-class FGFR isoform-selective inhibitors, offering an approach for treating advanced solid tumors harboring FGFR2/3 aberrations."

Preclinical • Oncology • Solid Tumor • FGFR1 • FGFR2 • FGFR3 • FGFR4

ctDNA monitoring of FGFR3-altered metastatic urothelial cancer treated with dabogratinib (formerly TYRA-300) in the SURF301 trial. (ASCO-GU 2026) - P1/2 | "Erdafitinib, a pan-FGFR inhibitor, is an approved targeted therapy for FGFR3-altered mUC. We observed frequent on-treatment reductions in plasma ctDNA in FGFR3-altered mUC patients receiving dabogratinib in the SURF301 trial. Molecular responses, suggestive of anti–tumor effect and adequate target coverage, were seen at all doses, with the deepest molecular responses occurring at doses of ≥90mg QD, in alignment with reported pharmacokinetic and pharmacodynamic evidence of drug activity."

Circulating tumor DNA • Metastases • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • FGFR3 • TACC3

A phase 2 multicenter, open-label study evaluating the efficacy and safety of dabogratinib (TYRA-300) in participants with FGFR3-altered low-grade, intermediate risk non-muscle invasive bladder cancer (SURF302). (ASCO-GU 2026) - P2 | "Recently, several pan-FGFR inhibitors have received regulatory approvals across multiple cancers, including erdafitinib in advanced urothelial carcinoma. Two doses will be initially tested (50 and 60 mg QD, n=30 each) in a randomized fashion. The study is planned for approximately 36 centers in North America, Australia, and Europe."

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • FGFR1 • FGFR2 • FGFR3 • FGFR4

Phase 1/2 mUC Study - SURF301 (PRNewswire) - "At ASCO GU 2026, TYRA presented a poster detailing the response, safety, pharmacokinetics/pharmacodynamics and circulating tumor DNA data from the SURF301 mUC study. These translational data were leveraged to select doses that have the potential to achieve the target product profiles for efficacy and safety in the SURF303, SURF302 and BEACH301 studies. TYRA is planning to publish final Phase 1 results from SURF301 in a future scientific publication."

P1 data • PK/PD data • Urothelial Cancer

Phase 2 IR NMIBC Study - SURF302 (PRNewswire) - "SURF302 is a Phase 2, multicenter, open-label clinical study evaluating the efficacy and safety of oral dabogratinib at two QD doses in participants with FGFR3-altered low-grade IR NMIBC. TYRA opened additional US and international trial sites in Q4 2025, and the Company expects to report initial three-month complete response data by the end of 1H 2026."

P2 data • Trial status • Bladder Cancer

Phase 2 LG-UTUC Study - SURF303 (PRNewswire) - "SURF303 is a Phase 2a/b, multicenter, open-label study designed with pivotal intent to evaluate the efficacy and safety of oral dabogratinib at two QD doses in participants with LG-UTUC, a rare cancer where approximately 85% of tumors are driven by FGFR3. Study startup is ongoing, and the first patient is anticipated to be dosed in 2026."

Trial status • Urothelial Cancer

TYR300-202: A multicenter, open-label, Phase 2 study of TYRA-300 in non-muscle invasive bladder cancer (clinicaltrialsregister.eu) - P1/2 | N=48 | Recruiting | Sponsor: Tyra Biosciences Inc.

New P1/2 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Tyra Biosciences…announced today that two abstracts have been accepted for presentation at the 2026 ASCO Genitourinary (GU) Cancers Symposium (ASCO GU) (PRNewswire)

Clinical data • Bladder Cancer • Urothelial Cancer

SURF303: Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma (clinicaltrials.gov) - P2 | N=230 | Recruiting | Sponsor: Tyra Biosciences, Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • Urothelial Cancer • FGFR3

SURF301: Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations (clinicaltrials.gov) - P1/2 | N=310 | Active, not recruiting | Sponsor: Tyra Biosciences, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

A Phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of Dabogratinib (TYRA-300) in Participants with FGFR3-Altered Low-Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302) (EAU 2026) - No abstract available

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • FGFR3

SURF303: Phase 2A/B Efficacy and Safety of Dabogratinib in Participants With Low Grade Upper Tract Urothelial Carcinoma (clinicaltrials.gov) - P2 | N=230 | Not yet recruiting | Sponsor: Tyra Biosciences, Inc

New P2 trial • Oncology • Solid Tumor • Urothelial Cancer • FGFR3