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Tyra Biosciences (TYRA) investor relations material
Tyra Biosciences Jefferies London Healthcare Conference 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Pipeline and clinical progress
Lead drug dabogratinib, an FGFR3 selective inhibitor, is advancing in phase II studies for upper tract urothelial carcinoma, intermediate risk NMIBC, and achondroplasia.
FGFR3 is a key genetic driver in bladder cancers and skeletal dysplasias, with high positivity rates in early-stage disease.
Achondroplasia and other FGFR3-driven short stature conditions represent significant opportunities for targeted therapy.
Dabogratinib is the only oral FGFR3 selective drug in clinical development for these indications.
Phase II studies are enrolling, with initial data readouts expected in the first half of next year for NMIBC and in the second half for achondroplasia.
Efficacy and safety data
Erdafitinib, a pan-FGFR inhibitor, showed high efficacy but significant toxicity due to off-target effects; dabogratinib aims to match efficacy with improved safety.
Dabogratinib demonstrated a marked reduction in FGFR1/2-related toxicities, such as nail disorders and hyperphosphatemia, compared to erdafitinib.
At 40 and 60 mg doses, dabogratinib showed a clean safety profile, with minimal liver enzyme elevations.
The ongoing NMIBC study is testing 50 and 60 mg doses, targeting efficacy similar to erdafitinib but with better tolerability.
Initial 3-month complete response data from 20-30 patients is expected by mid-next year.
Market opportunity and physician adoption
FGFR3-driven bladder cancers represent a multi-billion dollar market due to high unmet need and patient volume.
Oral therapies are increasingly favored by urologists, who have adapted their practices to benefit economically from in-office dispensing.
The oral option is expected to drive a dynamic switch market, with physician and patient preferences shaping adoption.
Expansion into upper tract urothelial carcinoma addresses a high-burden, hard-to-treat population with few alternatives.
The oral FGFR3 inhibitor could offer a Gleevec-like opportunity for long-term disease management.
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