Tyra Biosciences Unveils Early Data for FGFR3 Inhibitor, TYRA-300, in Challenge to J&J’s Balversa

Tyra Biosciences' Early Data:
Tyra Biosciences has released early proof-of-concept data for its investigational FGFR3 inhibitor, TYRA-300, showing encouraging anti-tumor activity in heavily pretreated patients with metastatic urothelial carcinoma.

Stock Reaction:
Despite the positive data, Tyra's stock fell 18% on the day of the announcement, as the data did not meet the high expectations that had driven the stock up over 100% ahead of the readout.

Comparison to Balversa:
TYRA-300 is designed to selectively target FGFR3, potentially offering better safety compared to J&J's Balversa, which targets multiple FGFRs and has been associated with substantial off-target effects.

Clinical Findings:
The Phase I/II SURF301 trial showed that all FGFR3-positive patients who received at least 90 mg of TYRA-300 experienced anti-tumor activity, with 50% achieving partial response and a 100% disease control rate at the 90-mg dose.

Safety Profile:
TYRA-300 was found to be well-tolerated with infrequent adverse events associated with FGFR2 and FGFR1, and no adverse events of grade 4 severity or higher were reported.

Market Opportunity:
Analysts suggest that Tyra could capitalize on the safety concerns associated with Balversa, making safety a key differentiating factor for TYRA-300 in the treatment of urothelial carcinoma.