Biohaven Ltd. (NYSE: BHVN) announced that Phase 1 clinical data on BHV-1530, its FGFR3-directed antibody-drug conjugate (ADC), have been selected for an oral presentation at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2026), scheduled for November 18-20, 2026, in Barcelona, Spain.

BHV-1530 uses Biohaven's proprietary topoisomerase I (TopoIx) payload and is being studied in the ongoing BHV1530-101 trial (NCT06874335), a Phase 1, first-in-human, open-label, multicenter study evaluating the drug as monotherapy and in combination with cemiplimab in adults with advanced or metastatic solid tumors. The presentation is scheduled for November 19, 2026, during Plenary Session 3.

According to the company's press release, early clinical data showed confirmed partial responses in heavily pretreated patients, with no dose-limiting toxicities and none of the class-related side effects typically associated with approved FGFR tyrosine kinase inhibitors, such as hyperphosphatemia, nail disorders, stomatitis, or retinopathy.

Biohaven also disclosed a clinical supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate BHV-1530 in combination with cemiplimab (Libtayo), with enrollment in that combination cohort now underway. The company said preclinical data showed synergistic activity between BHV-1530 and anti-PD-1 therapy, and that the TopoIx payload has been shown to generate immunogenic cell death.

The drug is being studied in patients with advanced urothelial cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer who have failed standard-of-care therapy, as well as other tumor types with FGFR3 genomic alterations. The agreement with Regeneron extends an existing collaboration that also covers BHV-1510, a TROP2-directed ADC.