On September 28, 2026 Biohaven Ltd. (NYSE: BHVN) ("Biohaven"), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, reported that data on BHV-1530, its FGFR3-directed antibody-drug conjugate (ADC) using a novel topoisomerase I (TopoIx) payload, have been accepted for an oral presentation at the 38th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (ENA 2026), to be held November 18-20, 2026, at the CCIB in Barcelona, Spain.
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Selection for an oral presentation at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium, one of the foremost venues for molecular-targeted and early-phase cancer therapeutics, underscores the scientific interest in FGFR3 as a therapeutic target and in Biohaven’s TopoIx ADC platform. Early clinical activity has been observed, including confirmed partial responses in heavily pretreated patients, as previously disclosed. The data have shown a favorable and differentiated safety profile, with no dose-limiting toxicities and no FGFR inhibitor-class toxicities, such as hyperphosphatemia, nail disorders, stomatitis, or retinopathy, that commonly constrain dosing and duration of approved FGFR tyrosine kinase inhibitors.
Presentation Title: Phase 1 study of BHV-1530, a first-in-class FGFR3 ADC in Advanced Tumors
Abstract / Presentation Number: 2
Session: Plenary Session 3
Date and Time: 19Nov2026 at 10:00am
The oral presentation will provide an update from the ongoing BHV1530-101 study (NCT06874335), a Phase 1, first-in-human, open-label, multicenter, dose-escalation, dose-expansion and dose-confirmation study evaluating BHV-1530 as monotherapy and in combination with cemiplimab in adult participants with advanced or metastatic solid tumors.
BHV-1530 is designed to address FGFR3-driven cancers, including tumors with FGFR3 alterations and possibly, those with wild-type FGFR3 overexpression, a population not addressed by approved FGFR tyrosine kinase inhibitors. Further details, including the presentation title and session information, will be available in the ENA 2026 program.
Clinical Supply Agreement with Regeneron for BHV-1530 and Cemiplimab
Biohaven has entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate the combination of BHV-1530 and cemiplimab (Libtayo) in patients with solid tumors, based upon previously disclosed emerging monotherapy clinical data and preclinical data demonstrating synergistic activity between BHV-1530 and Anti-PD-1 therapy. Enrollment into the combination cohort evaluating BHV-1530 with cemiplimab has begun. BHV-1530’s TopoIx payload has been demonstrated to generate immunogenic cell death and stimulate an antitumor immune response, providing a compelling mechanistic rationale for combination with checkpoint inhibition. This agreement builds upon the existing clinical supply agreement between Biohaven and Regeneron for BHV-1510, a next-generation TROP2-directed ADC, further deepening the collaborative relationship between the two companies across Biohaven’s oncology pipeline.
About BHV-1530
BHV-1530 is an antibody-drug conjugate directed against FGFR3, a validated but underexploited target in urothelial cancer and other FGFR3-driven cancers, and is a first-in-class potential FGFR3-directed ADC incorporating Biohaven’s proprietary TopoIx payload. Unlike approved FGFR tyrosine kinase inhibitors, which are restricted to genomically selected patients and constrained by class-related toxicities, BHV-1530 is designed to target FGFR3 independent of requiring pathway inhibition, with the potential to address both FGFR3-altered and wild-type overexpressing tumors. BHV-1530 is being studied in an ongoing Phase 1 dose-escalation trial in unselected 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 harboring FGFR3 genomic alterations. Biohaven has initiated combination cohorts evaluating BHV-1530 with anti-PD-1 therapy, including the combination with cemiplimab (Libtayo), which is now enrolling.
(Press release, Biohaven Pharmaceutical, SEP 28, 2026, View Source [SID1234671121])