PR Newswire·Jul 20, 2026, 7:30 AM ET

Biohaven to Present New Clinical Data at ESMO Congress on BHV-1530, a Novel FGFR3-Directed ADC With a Proprietary Topoisomerase I (TopoIx) Payload

Biohaven announced a new clinical supply agreement with Regeneron to evaluate BHV-1530 in combination with cemiplimab (Libtayo) for solid tumors.
Early Phase 1 dose-escalation data for BHV-1530 showed tumor reductions in patients with FGFR3-altered & wild-type overexpressing tumors across multiple cancer types.
The drug demonstrated a differentiated safety profile with no dose-limiting toxicities & no FGFR inhibitor-class toxicities, such as hyperphosphatemia or nail disorders.
BHV-1530 targets FGFR3 regardless of alteration status, potentially expanding the addressable population to include ~50% of metastatic urothelial cancer cases with wild-type overexpression.
Biohaven plans to initiate combination cohorts with anti-PD-1 therapy, including the cemiplimab collaboration, in the second half of 2026.
New Phase 1 data on BHV-1530 will be presented at the ESMO Congress 2026 in Madrid on October 23, 2026.
Preclinical data support the combination strategy, showing that BHV-1530's TopoIx payload generates immunogenic cell death & stimulates antitumor immune responses.
The agreement builds on an existing collaboration between Biohaven & Regeneron for the BHV-1510 TROP2-directed ADC program.