TLDR
- Tyra Biosciences stock fell 22% to $20.96 after Phase 2 trial data for bladder cancer pill dabogratinib disappointed investors
- The drug hit a 64% complete response rate at the 60mg dose, missing the 70% benchmark analysts had set as the minimum for success
- Safety data was favorable with no Grade 4-5 events and no dose reductions at 60mg
- Tyra plans to test a higher 70mg dose in a new cohort and advance the drug into late-stage studies
- UroGen Pharma (URGN) rose 5.6% on the news, as its competing bladder cancer treatment Zusduri gained ground
Tyra Biosciences stock dropped 22% to $20.96 on Wednesday after Phase 2 trial results for its oral bladder cancer drug dabogratinib fell short of what analysts were looking for.
The Phase 2 SURF302 trial tested dabogratinib in 44 adults with FGFR3-altered low-grade intermediate-risk non-muscle invasive bladder cancer. The drug delivered a 79% overall response rate but only a 64% best overall complete response rate at the 60mg once-daily dose.
The problem? Analysts at Piper Sandler and H.C. Wainwright had publicly set 70% as the bar for success. A 64% result is a clear miss against that benchmark.
Piper Sandler had held an Overweight rating and a $56 price target on the stock. The firm had modeled this bladder cancer indication as a greater-than-$1 billion opportunity for the drug.
The stock had also run up about 13% in the week before the data dropped, meaning investors had already priced in a strong result. That made the selloff sharper than it might otherwise have been.
On the safety side, the picture was cleaner. Most adverse events were Grade 1 or 2, there were no Grade 4 or 5 events, and there were no dose reductions or discontinuations related to treatment at the 60mg level.
What Comes Next for Dabogratinib
Tyra is not walking away from the program. Management said it plans to test a higher 70mg dose in a new study cohort and move dabogratinib into late-stage studies.
CEO Todd Harris pointed to the drug’s potential as the first once-daily oral therapy in this cancer type. Chief Medical Officer Doug Warner confirmed the plan to advance into registrational-stage development.
Jones Trading analyst Boris Peaker said the results are not program-terminating, but warned the 70mg dose exploration “will come at the cost of additional safety concerns.”
Some analysts had flagged early on that an oral pill might not deliver enough of the drug directly into the bladder to compete with direct instillation via catheter. Wednesday’s results appeared to support that concern.
Competitors Take Notice
The data gave a boost to UroGen Pharma, whose prescription chemotherapy Zusduri is delivered directly through a catheter. URGN stock rose 5.6% on Wednesday.
Johnson and Johnson is also in the mix with Erda-iDRS, an early-stage drug delivery system designed to release the targeted kinase inhibitor erdafitinib directly into the bladder over three months.
The macro backdrop did not help Tyra on Wednesday. The S&P 500, Dow, and Nasdaq were all modestly lower in pre-market trading, with investor caution running high after a stronger-than-expected August jobs report raised questions about the Fed’s next move.
Pre-market, TYRA had fallen as far as 31.1% to $18.42 before recovering somewhat by the open.
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