Tyra Biosciences (TYRA) Shares Plunge 22% as Bladder Cancer Drug Trial Falls Short

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TLDRShares of Tyra Biosciences plummeted 22% to $20.96 following underwhelming Phase 2 clinical trial results for its bladder cancer medication dabogratinibThe experimental therapy achieved a 64% complete response rate at its 60mg dosage, falling short of the 70% threshold that Wall Street analysts had designated as critical for successThe drug demonstrated encouraging safety results with no serious Grade 4-5 adverse events and zero dose reductions required at the 60mg levelThe company intends to evaluate a higher 70mg dosage in an upcoming patient cohort and progress the medication into advanced clinical development phasesShares of UroGen Pharma (URGN) climbed 5.6% following the announcement, as its rival bladder cancer therapy Zusduri positioned itself more favorablyTyra Biosciences witnessed its shares tumble 22% to $20.96 on Wednesday following the release of Phase 2 clinical trial data for its oral bladder cancer medication dabogratinib, which disappointed Wall Street expectations.Tyra Biosciences, Inc., TYRAThe company’s Phase 2 SURF302 clinical study evaluated dabogratinib in 44 adult patients diagnosed with FGFR3-altered low-grade intermediate-risk non-muscle invasive bladder cancer. While the medication achieved a 79% overall response rate, it only managed a 64% best overall complete response rate when administered at the 60mg once-daily dosage.The issue? Wall Street analysts from Piper Sandler and H.C. Wainwright had established 70% as the critical threshold for considering the trial successful. Achieving only 64% represents a notable shortfall against that established benchmark.Piper Sandler had maintained an Overweight rating on the company with a price target of $56. The investment firm had projected this bladder cancer application as representing a market opportunity exceeding $1 billion for the medication.The stock had already gained approximately 13% during the week preceding the data announcement, suggesting investors had anticipated positive results. This pre-positioning amplified the subsequent selloff beyond what might have occurred otherwise.Regarding safety metrics, the results were more encouraging. The majority of adverse events were classified as Grade 1 or 2 in severity, with no Grade 4 or 5 events recorded, and no patients requiring dose reductions or treatment discontinuation at the 60mg dosage level.What Lies Ahead for DabogratinibTyra has no intentions of abandoning the development program. Company leadership announced plans to evaluate a higher 70mg dosage in a fresh study cohort while advancing dabogratinib toward late-stage clinical trials.CEO Todd Harris emphasized the medication’s potential as the first once-daily oral treatment option in this specific cancer category. Chief Medical Officer Doug Warner validated the strategy to proceed into registrational-stage development.Jones Trading analyst Boris Peaker noted that while the results don’t warrant terminating the program, he cautioned that exploring the 70mg dosage “will come at the cost of additional safety concerns.”Several analysts had previously raised concerns that an oral medication might not deliver sufficient drug concentration directly to the bladder tissue to compete effectively with direct instillation methods using catheters. Wednesday’s trial outcomes appeared to validate those concerns.Competitive Landscape ShiftsThe disappointing data provided a boost to UroGen Pharma, whose prescription chemotherapy treatment Zusduri is administered directly via catheter. URGN shares advanced 5.6% on Wednesday.Johnson and Johnson is also competing in this space with 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 added pressure to Tyra’s stock on Wednesday. The S&P 500, Dow Jones Industrial Average, and Nasdaq all traded modestly lower during pre-market hours, with investor sentiment cautious following a robust August jobs report that complicated expectations around the Federal Reserve’s upcoming policy decisions.During pre-market trading, TYRA shares had declined as much as 31.1% to $18.42 before experiencing some recovery by the market open.The post Tyra Biosciences (TYRA) Shares Plunge 22% as Bladder Cancer Drug Trial Falls Short appeared first on Blockonomi.