TLDR
- Shares of Tyra Biosciences plummeted 22% to $20.96 following underwhelming Phase 2 results for its bladder cancer medication dabogratinib
- The experimental therapy achieved a 64% complete response rate at 60mg dosing, falling below the 70% threshold analysts established for clinical success
- The trial showed promising safety outcomes with no severe Grade 4-5 adverse events and zero dose reductions at the 60mg level
- The company intends to evaluate a higher 70mg dosing regimen in an additional cohort and proceed with late-stage clinical development
- Shares of UroGen Pharma (URGN) climbed 5.6% as its rival bladder cancer therapy Zusduri appeared to benefit from Tyra’s setback
Tyra Biosciences experienced a sharp 22% decline to $20.96 on Wednesday following the release of Phase 2 clinical trial data for dabogratinib, its oral bladder cancer candidate, which failed to meet Wall Street expectations.
The Phase 2 SURF302 study evaluated dabogratinib in 44 adult patients diagnosed with FGFR3-altered low-grade intermediate-risk non-muscle invasive bladder cancer. While the therapy achieved a 79% overall response rate, it managed only a 64% best overall complete response rate at the 60mg once-daily dosing regimen.
The issue? Leading Wall Street firms including Piper Sandler and H.C. Wainwright had established 70% as the minimum threshold for clinical success. The 64% outcome represents a notable shortfall against that expectation.
Piper Sandler maintained an Overweight rating with a $56 price objective on the shares. The investment bank had projected this bladder cancer application could represent a market opportunity exceeding $1 billion for dabogratinib.
Adding to the dramatic selloff, shares had surged approximately 13% during the week preceding the data release, suggesting investors had anticipated positive results. This pre-event rally amplified the subsequent decline.
From a safety perspective, the data was more encouraging. The majority of adverse events were classified as Grade 1 or 2, with no Grade 4 or 5 events observed, and zero treatment-related dose reductions or discontinuations at the 60mg dose level.
Future Development Plans for Dabogratinib
Tyra remains committed to the development program. Company leadership announced plans to evaluate a 70mg dose in a new study cohort while advancing dabogratinib into later-stage clinical trials.
Chief Executive Officer Todd Harris emphasized the medication’s potential to become the first once-daily oral treatment option in this cancer indication. Chief Medical Officer Doug Warner reaffirmed the company’s intention to progress into registration-enabling development phases.
Jones Trading analyst Boris Peaker noted the outcomes aren’t sufficient to terminate the program, though he cautioned that testing the 70mg dose “will come at the cost of additional safety concerns.”
Several analysts had previously raised questions about whether an oral formulation could deliver adequate drug concentrations directly to bladder tissue to compete with catheter-based instillation methods. Wednesday’s data appeared to validate those reservations.
Competitive Landscape Shifts
The clinical data provided a lift to UroGen Pharma, whose prescription chemotherapy Zusduri is administered directly via catheter. URGN shares gained 5.6% on Wednesday.
Johnson and Johnson is also developing Erda-iDRS, an investigational drug delivery platform engineered to release the targeted kinase inhibitor erdafitinib directly into bladder tissue over a three-month period.
Broader market conditions compounded Tyra’s challenges on Wednesday. The S&P 500, Dow Jones, and Nasdaq all traded modestly lower in pre-market activity, with investor sentiment dampened following a robust August employment report that complicated expectations for Federal Reserve policy decisions.
During pre-market trading, TYRA shares had declined as much as 31.1% to $18.42 before stabilizing somewhat at the opening bell.
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