Biohaven's Clinical Data on BHV-1530, a Novel FGFR3-Directed ADC With a Proprietary Topoisomerase I (TopoIx) Payload, Selected for Oral Presentation at the EORTC-NCI-AACR Symposium 2026

BHV1530-101 is a first-in-human, open-label, multicenter study; enrollment in its combination cohort has begun.

Rhea-AI Summary

Biohaven (BHVN) will present Phase 1 BHV-1530 clinical data at the EORTC-NCI-AACR oncology symposium in November 2026. The November 19 oral presentation in Barcelona will update the ongoing BHV1530-101 study of the FGFR3-directed antibody-drug conjugate. Previously disclosed findings included confirmed partial responses in heavily pretreated patients. No dose-limiting toxicities or FGFR inhibitor-class toxicities were observed in the reported data.

Biohaven has begun enrolling a cohort testing BHV-1530 with cemiplimab (Libtayo) under a clinical supply agreement with Regeneron Pharmaceuticals. The study evaluates BHV-1530 alone and with cemiplimab in adults with advanced or metastatic solid tumors. It includes dose escalation, expansion and confirmation.

Market Context

The July 20 BHV-1530 update coincided with a reported -3.76% 24-hour move; it included early respons...

Analysis

The July 20 BHV-1530 update coincided with a reported -3.76% 24-hour move; it included early responses, tolerability findings and the Regeneron combination plan, providing same-program context for this presentation and enrollment update.

Key Figures

Study phase: Phase 1

Study phase

Phase 1

Ongoing BHV1530-101 study

Previous Clinical trial Reports

1 past event · Latest: Jul 20

Same Type 1 event

1. Jul 20

   clinical data update

   24h Move

   -3.8%

   Phase 1 BHV-1530 update described responses, tolerability and a Regeneron combination agreement.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

antibody-drug conjugate, topoisomerase i, dose-limiting toxicities, open-label, +2 more

6 terms

antibody-drug conjugate medical

"its FGFR3-directed antibody-drug conjugate (ADC)"

An antibody-drug conjugate is a targeted medicine that combines an antibody, which can identify specific cells, with a powerful drug designed to destroy those cells. This approach allows for precise treatment, minimizing damage to healthy tissue. For investors, developments in this area can signal advances in cancer therapies and potential growth opportunities in the biotech sector.

topoisomerase i medical

"using a novel topoisomerase I (TopoIx) payload"

An enzyme that helps cells manage DNA’s twisting and untangling during copying and repair by cutting and resealing the strands — like a tiny molecular ‘untangler’ that prevents knots when DNA is duplicated. It matters to investors because drugs that block this enzyme can selectively kill fast‑growing cancer cells, so clinical trial results, patents, or regulatory decisions around topoisomerase I inhibitors can meaningfully affect biotech valuations and potential revenue.

dose-limiting toxicities medical

"with no dose-limiting toxicities"

Dose-limiting toxicities are the harmful side effects seen in early clinical trials that are severe enough to stop researchers from raising a drug’s dose. Like a car’s speed limiter marking the safe top speed, DLTs define the maximum tolerable dose, and they matter to investors because they determine whether a medicine can reach effective levels, influence development timelines, costs, and regulatory chances, and thus affect a drug’s commercial prospects.

open-label medical

"a Phase 1, first-in-human, open-label, multicenter"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

dose-escalation medical

"multicenter, dose-escalation, dose-expansion"

Dose-escalation is the part of an early-stage clinical trial where researchers gradually increase a drug’s dose in small groups of participants to find the safest and most effective amount. Think of it like turning up the volume slowly to find the sweet spot: investors watch these results closely because they reveal safety risks, potential effectiveness, and how quickly a drug can move to later trials or approval, all of which affect the development timeline and commercial prospects.

partial responses medical

"including confirmed partial responses in heavily pretreated patients"

A partial response is when a treatment produces a clear, measurable improvement in a disease—such as reduced tumor size or better lab markers—but does not eliminate the condition entirely. For investors, partial responses signal that a drug or therapy is biologically active and may provide clinical benefit, yet they also indicate remaining unmet need, which affects the size of the potential market, pricing power, regulatory likelihood, and prospects for further development.

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• Oral presentation selected: Phase 1 findings from the ongoing BHV1530-101 study will be featured in an oral presentation at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2026), a leading international forum for early-phase oncology drug development.
• First-in-class FGFR3 ADC: BHV-1530 is a first-in-class potential FGFR3-directed antibody-drug conjugate incorporating Biohaven's proprietary TopoIx payload, that has shown early clinical activity with a differentiated and tolerable safety profile.
• Anti-PD-1 combination now enrolling: Under its clinical supply agreement with Regeneron Pharmaceuticals, Inc., Biohaven has begun enrollment, evaluating BHV-1530 in combination with cemiplimab (Libtayo).

NEW HAVEN, Conn., Sept. 28, 2026 /PRNewswire/ -- 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, today announced 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 Symposium on Molecular Targets and Cancer Therapeutics (ENA 2026), to be held November 18-20, 2026, at the CCIB in Barcelona, Spain.

Selection for an oral presentation at the EORTC-NCI-AACR 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.

About Biohaven
Biohaven Ltd. (NYSE: BHVN) is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. Biohaven is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; and myostatin inhibition for neuromuscular and metabolic diseases, including obesity. For more information, visit www.biohaven.com.

Forward-Looking Statements
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected timing, conduct, and outcomes of Biohaven's ongoing and planned clinical trials of BHV-1530, including the combination with cemiplimab under the clinical supply agreement with Regeneron, the potential therapeutic benefits, efficacy, safety, and tolerability of BHV-1530, and the timing of planned regulatory interactions and filings. The use of certain words, including "continue," "plan," "will," "believe," "may," "expect," "anticipate," "on track," "potential," and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors, including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates and the expected timing thereof; the potential for Biohaven's product candidates to be successful therapies; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations." The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

MoDE and TRAP are trademarks of Biohaven Therapeutics Ltd.

Libtayo is a registered trademark of Regeneron Pharmaceuticals, Inc.

Investor Contact:
Jennifer Porcelli
Vice President, Investor Relations
jennifer.porcelli@biohavenpharma.com
+1 (201) 248-0741

Media Contact:
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
+1 (312) 961-2502

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SOURCE Biohaven Ltd.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What have Biohaven's BHV-1530 clinical findings shown so far?

Previously disclosed findings included confirmed partial responses in heavily pretreated patients. No dose-limiting toxicities or FGFR inhibitor-class toxicities were observed in the reported data.

Has Biohaven started testing BHV-1530 with cemiplimab?

Biohaven has begun enrolling patients in the cohort evaluating BHV-1530 with cemiplimab (Libtayo). The combination is being studied under a clinical supply agreement with Regeneron Pharmaceuticals.

Why is Biohaven studying BHV-1530 with cemiplimab?

Biohaven bases the combination study on previously disclosed monotherapy data and preclinical data showing synergistic activity between BHV-1530 and anti-PD-1 therapy. Its TopoIx payload has also been shown to generate immunogenic cell death and stimulate an antitumor immune response.