Tyra Biosciences is taking on Johnson & Johnson to develop a next-generation treatment common type of bladder cancer, but the latest data for its experimental pill failed to inspire confidence.
The Phase 2 trial evaluted dabogratinib in 44 adults with early-stage non-muscle invasive bladder cancer. Its primary endpoint was the 3-month complete response rate (CRR), or the percentage of patients with no detectable signs of cancer following treatment.
Although Tyra reported favorable safety and tolerability that support the drug's potential for long-term use, the results weren't enough to satisfy investors as shares plunged 22% to $20.96 on Wednesday.
The market reaction may be overblown. Such dramatic stock swings are typical for a small-cap biotech, as evidenced by Tyra's recent price action: On Sept. 4, shares surged as much as 18% in intraday trading after the company announced its plan to release the Phase 2 data.
Some analysts had suspected an oral pill wouldn't deliver enough of the drug directly into the bladder to be effective as the usual method of direct instillation through a catheter, which is what appeared to have panned out.
Yet Wall Street isn't souring on Tyra entirely. The results may be lukewarm, but they aren't program-terminating, according to Jones Trading analyst Boris Peaker.
There is still time for Tyra to turn things around. The company plans to test a higher 70-milligram dose in a new study cohort, which may be more effective, though Peaker notes that this "will come at the cost of additional safety concerns."
Management remains cautiously optimistic. CEO Todd Harris highlighted the drug's potential as the first once-daily oral therapy, while Chief Medical Officer Doug Warner confirmed plans to advance dabogratinib into late-stage studies.
Although surgery is the traditional standard of care, non-invasive alternatives have emerged. Key among them is Zusduri, a prescription chemotherapy delivered directly through a catheter. Shares of manufacturer UroGen Pharma rose 5.6% on Wednesday
Similar to Tyra, J&J is seeking to disrupt the standard of care. The pharmaceutical giant's lead candidate, Erda-iDRS, is an early-stage drug delivery system engineered to release the targeted kinase inhibitor erdafitinib directly into the bladder over three months.