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TYRABearishIndustry Newsnews
High materiality7/10

Tyra's Dabogratinib SURF302: 86% ORR at Target Exposure Drives Adjuvant Path

Sep 9, 2026, 1:26 PM EDT1 sourcesAI-analyzed
Why it may matterVerify against the original reporting

Immediate stock decline after a mixed readout (CR below prior expectations) despite strong ORR at target exposure; recalibration risk for the adjuvant path and Phase 3 timing; near-term uncertainty could persist until clearer regulatory/clinical milestones are outlined.

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What happened, with direct paths to the underlying reporting

Tyra Biosciences reported Phase 2 SURF302 results for dabogratinib in FGFR3-altered non-muscle invasive bladder cancer, showing 86% overall response at target exposure in 26 evaluable patients and supporting a 60 mg daily dose for adjuvant studies. Management intends to finish enrolling the 60 mg group, add a 70 mg cohort, and advance Phase 3 discussions with regulators, while SURF303 initial upper tract data showed a 60 mg daily complete response at three months with no adverse events. The stock reacted negatively, underscoring near-term volatility as investors reassess the readout's implications for the registry path.

  • Tyra's SURF302 readout shows 86% ORR at target exposure in 26 evaluable patients.
  • 60 mg daily dose supported for adjuvant trials; CR 57% at 60 mg.
  • Stock fell about 21-22% on the news; analysts note expectations were higher.
  • TYRA plans 70 mg cohort and Phase 3 design discussions with health authorities.
  • SURF303 upper tract results show 60 mg daily CR at 3 months with no adverse events.

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