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 expected to be initiated in 2027.
SEC timing context:
ata, TYRA also reported that based on third party published data, it is estimated that approximately 70% of patients with LG IR NMIBC do not receive adjuvant therapy intended to reduce recurrence, despite evidence that intravesical treatment lowers recurrence risk. Based on third-party market research, TYRA estimates a potential total market opportunity for IR NMIBC of greater than $5 billion, assuming full penetration of branded agents across the FGFR3-altered patient population. Dose-optimization and registrational strategy. • Preliminary exposure-response analyses across the 50 mg QD and 60 mg QD cohorts showed an ORR of 86% (12/14) among participants with a target steady-state exposure above the AUC threshold of 2500 ng.hr/mL, compared with 58% (7/12) among participants below the threshold. The exposure-response relationship was most apparent among participants with multiple marker lesions, while responses in participants with a single marker lesion occurred across the observed exposure range — supporting 60 mg QD in the planned adjuvant setting, where disease burden is minimal, and the evaluation of a higher dose in the ablative setting. • 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 expected to be initiated in 2027.
Initial results from the safety sentinel cohort, including 6-month annualized height velocity and safety data from all five dose levels, are expected to be reported at the end of the first quarter of 2027, which will include an aggregate of approximately 25 children.
SEC timing context:
s expected in 2027. SURF302 for IR NMIBC: This open-label Phase 2 clinical trial is evaluating the efficacy and safety of oral dabogratinib at 50 mg and 60 mg QD in participants with FGFR3-altered low-grade IR NMIBC, where approximately 70% of tumors are driven by FGFR3. The Company expects to report initial results from both dose cohorts during a conference call and webcast in September 2026, including safety results from more than 40 patients and efficacy from more than 20 patients in the aggregate at both QD dose levels. BEACH301 for ACH: This study is an open-label, Phase 2 dose-escalation/dose-expansion trial evaluating oral dabogratinib at multiple doses (0.125, 0.25, 0.375, 0.50, and 0.625 mg/kg), in children ages 3 to 10 with ACH with open growth plates, where approximately 99% of cases are driven by FGFR3. The study has enrolled the safety sentinel cohort, consisting of at least 3 participants per dose level in children ages 5 to 10, and is enrolling a natural history run-in for cohorts 1 and 2 with children ages 3 to 10. No notable safety events have been reported to date. Initial results from the safety sentinel cohort, including 6-month annualized height velocity and safety data from all five dose levels, are expected to be reported at the end of the first quarter of 2027, which will include an aggregate of approximately 25 children.
Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .
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dabogratinibOther
in 2027
“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 expected to be initiated in 2027.”
The stated period has not started yet, so there is nothing to compare.
dabogratinibClinical results
the end of the first quarter of 2027
“Initial results from the safety sentinel cohort, including 6-month annualized height velocity and safety data from all five dose levels, are expected to be reported at the end of the first quarter of 2027, which will include an aggregate of approximately 25 children.”
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