Biohaven Ltd.

Biohaven Drives New Research in Graves' Disease: Phase 3 Pivotal Trial with BHV-1300 Underway and Three Scientific Posters at the 2026 American Thyroid Association Annual (ATA) Meeting

Biohaven's Phase 3 trial of BHV-1300 in Graves' disease is enrolling at more than 55 sites in the US and Canada, with additional sites opening in Japan, the UK, Australia and the EU. In Phase 1b, weekly subcutaneous BHV-1300 cut pathogenic anti-TSHR-IgG1 autoantibodies by roughly 80% by week 12 and normalized free T4 and free T3 in hyperthyroid patients while sparing protective IgG3. The release also recaps October 2026's Ono Pharmaceutical deal licensing the MoDE pan-IgG portfolio in Japan, South Korea, Taiwan and ASEAN for $80 million upfront plus a $20 million milestone and ~20% royalties. Three ATA posters cover the patient burden of Graves' disease and preclinical data for next-gen TRAP degrader BHV-1440, which restored normal thyroid function in mouse models.

•3d ago

Biohaven Oral Presentation at ASN Kidney Week 2026 Spotlights BHV-1420, a Novel TRAP Degrader Designed to Selectively Remove the Autoantibodies that Drive Membranous Nephropathy

Biohaven presented preclinical data for BHV-1420, its second TRAP degrader, at ASN Kidney Week 2026, targeting the anti-PLA2R autoantibodies that drive membranous nephropathy. In a clinical diagnostic ELISA, BHV-1420 brought 88% of anti-PLA2R-positive patient samples (n=59) below the positivity threshold, and in mice a single subcutaneous dose depleted >90% of circulating autoantibody within two hours, sustained for 72 hours. BHV-1420 joins BHV-1400 in IgA nephropathy in the Yale-licensed nephrology franchise; BHV-1400 has shown ~70% Gd-IgA1 reduction in a Phase 1b IgAN study. BHV-1420 remains preclinical and unaudited by regulators, and Biohaven says it continues to evaluate strategic partnerships for the platform.

•13d ago

Biohaven Enters Strategic Licensing Agreement with Ono Pharma for Extracellular IgG Degraders in Japan and Select Asian Regions, Lead Candidate BHV-1300 in Phase 3 for Graves' Disease

Biohaven licensed its MoDE pan-IgG degrader portfolio, led by Phase 3 Graves' disease candidate BHV-1300, exclusively to Ono Pharmaceutical for Japan, South Korea, Taiwan, and ASEAN. Biohaven receives up to $100 million near-term — $80M upfront plus a $20M milestone anticipated within a year — plus roughly 20% royalties on net sales, while retaining all rights in the US, Europe, and China. Management framed the deal as the first regional collaboration for an extracellular protein degrader and emphasized the non-dilutive capital validates the MoDE platform without diluting long-term upside.

•1mo ago

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

Biohaven's Phase 1 clinical data on BHV-1530, a first-in-class FGFR3-directed ADC with its proprietary TopoIx payload, was selected for an oral presentation at the EORTC-NCI-AACR Symposium in Barcelona, November 18-20, 2026. Early clinical activity includes confirmed partial responses in heavily pretreated patients, with no dose-limiting toxicities and none of the class toxicities seen with approved FGFR kinase inhibitors. Enrollment has begun in a combination cohort with Regeneron's cemiplimab (Libtayo) under a new clinical supply agreement, building on a prior agreement covering BHV-1510.

•1mo ago

Biohaven and SK Biopharmaceuticals Enter into Strategic Global Licensing Agreement for Novel Kv7 Ion Channel Platform and Opakalim, Lead Candidate for Epilepsy

Biohaven licensed its Kv7 ion channel platform and lead asset opakalim to SK Biopharmaceuticals in a deal worth up to $795 million, providing significant non-dilutive capital. The agreement includes $400 million in upfront cash payments to Biohaven, consisting of $350 million at closing and $50 million in 2027, while SK Biopharmaceuticals assumes all future development costs. Opakalim is currently in Phase 2/3 development for focal epilepsy, and the partnership leverages SK Biopharmaceuticals' established commercial infrastructure and experience with XCOPRI to accelerate the drug's path to market.

•2mo ago

Federal Court Enters Judgment Confirming RA Capital and Avilar Therapeutics Willfully and Maliciously Misappropriated Trade Secret Developed at Yale, Formalizing $4 Million Award to Biohaven and Yale University

The U.S. District Court for the District of Delaware entered judgment in favor of Biohaven and Yale, confirming that RA Capital and Avilar Therapeutics willfully and maliciously misappropriated trade secrets related to the MODA platform. The judgment formalizes a combined $4 million award, consisting of $1 million to Biohaven and the remainder to Yale, stemming from breach of contract and trade secret misappropriation claims. This ruling validates Biohaven's intellectual property rights for its targeted protein degradation technology, legally clearing a path for the platform's development.

•2mo ago

Biohaven Reports Recent Business Developments and Second Quarter 2026 Financial Results

Biohaven reported a significant narrowing of its Q2 net loss to $137.3 million, or $0.91 per share, down from $198.1 million a year ago, while maintaining a cash position of $270.5 million. Clinical updates highlighted robust data for the MoDE platform, with BHV-1300 achieving >80% antibody reduction in Graves' disease and BHV-1400 showing >60% Gd-IgA1 reduction in IgA nephropathy, leading to the initiation of a pivotal Phase 3 study for BHV-1300. The company also advanced its neurology and oncology pipelines, reporting durable seizure control for opakalim and establishing a new clinical supply agreement with Regeneron for BHV-1530.

•2mo ago

Biohaven Appoints Technology Investor John Yetimoglu to Board of Directors

Biohaven appointed John Yetimoglu to its Board of Directors, effective immediately, to strengthen its expertise in artificial intelligence and technology investing. Mr. Yetimoglu is the Founder of Infinitum and a board member at AI inference computing firm Groq, bringing experience from a landmark $20 billion transaction with NVIDIA. The company expects his perspective to enhance strategic oversight as Biohaven integrates AI and machine learning into drug discovery and clinical development.

•3mo ago

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 that new Phase 1 data for BHV-1530 will be presented at the ESMO Congress, showing early tumor reductions and confirmed partial responses in heavily pretreated patients. The study reported a differentiated safety profile with no dose-limiting toxicities observed, potentially allowing treatment of patients with wild-type FGFR3 overexpression. Biohaven also entered into a clinical supply agreement with Regeneron to evaluate BHV-1530 in combination with cemiplimab (Libtayo) for solid tumors.

•3mo ago

Biohaven Completes Enrollment in RISE 3 Pivotal Focal Epilepsy Study with Opakalim, a Selective Kv7.2/7.3 Activator

Biohaven completed enrollment in the pivotal RISE3 study evaluating Opakalim for refractory focal epilepsy, with top-line results expected in the second half of 2026. Interim data from an open-label extension study demonstrated that 54% of participants on the 75 mg dose achieved a 50% or greater reduction in seizure frequency, alongside a favorable tolerability profile with low rates of nervous system adverse events. High retention rates, with approximately 95% of participants completing the double-blind phase and rolling over into the extension study, suggest a positive patient experience with the treatment.

•4mo ago

Biohaven Advances a New Class of Precision Immunology Therapies: First MoDE Extracellular Protein Degrader, BHV-1300, Begins Phase 3 Pivotal Trial in Graves' Disease

Biohaven enrolled the first patient in a pivotal Phase 3 trial of BHV-1300, the first MoDE extracellular protein degrader to reach this stage, for the treatment of Graves' disease. The therapy targets the TSHR-IgG1 autoantibody driving the disease rather than the thyroid gland itself, addressing a significant unmet need as no new FDA-approved therapies have emerged in over 70 years. Phase 1b data showed greater than 80% reduction of pathogenic autoantibodies and rapid normalization of thyroid hormones; the Phase 3 trial will enroll approximately 300 adults with data expected at 26 weeks.

•4mo ago

Biohaven Reports First-in-Human Dosing of Oral PKM2 Modulator, BHV-8100, Targeting Metabolic Restoration and Immunomodulation

Biohaven initiated first-in-human Phase 1 dosing of BHV-8100, an oral, brain-penetrant PKM2 modulator targeting metabolic restoration and immunomodulation. Preclinical data using the Bexorg BrainEx platform showed 3-fold improvement in glucose utilization in human brains, with preferential metabolic rescue in Alzheimer's disease donor brains versus controls. Preliminary pharmacokinetic data from healthy participants supports once-daily dosing and a well-tolerated profile at projected therapeutic exposures.

•5mo ago

Biohaven Reports Positive Clinical Biomarker and Patient Data: First MoDE and TRAP Extracellular Protein Degraders Achieve Deep, Rapid, Selective Lowering of Disease-Driving Antibodies in Graves' Disease and IgA Nephropathy

Biohaven reported positive Phase 1b data for BHV-1300 in Graves' disease, showing >80% reduction in pathogenic TSHR-IgG1 antibodies and normalization of thyroid hormones within 3-5 weeks. For IgA nephropathy, BHV-1400 achieved >60% reduction in pathogenic Gd-IgA1 within 48 hours and 70% within one month, with associated improvements in kidney function markers (eGFR, UPCR). Both assets demonstrated strong safety profiles with no serious adverse events, supporting the initiation of pivotal Phase 3 trials in mid-2026.

•5mo ago

Biohaven Reports New Clinical Data in Epilepsy with Opakalim, a Selective Kv7.2/7.3 Activator, Highlighting Seizure Control and Markedly Differentiated Tolerability Profile

Biohaven reported positive clinical data for Opakalim in epilepsy, highlighting a 3-fold prolongation in time to second seizure in idiopathic generalized epilepsy (IGE) vs. placebo (141 days vs. 47 days). In focal epilepsy, 54% of patients in the open-label extension achieved a ≥50% reduction in seizure frequency, matching competitor efficacy but with significantly lower rates of CNS side effects like dizziness and somnolence. The company expects top-line results from its pivotal Phase 2/3 studies in refractory focal epilepsy in the second half of 2026, supporting registration.

•5mo ago

Biohaven Reports Recent Business Developments and First Quarter 2026 Financial Results

Biohaven reported a Q1 2026 net loss of $130.5 million, or $0.88 per share, with R&D expenses decreasing to $103.8 million due to strategic reprioritization. The company ended the quarter with $351.8 million in cash and equivalents, supporting its development pipeline. Operational highlights include completed enrollment in the Phase 2 obesity study for taldefgrobep alfa and expected mid-year initiations of pivotal trials for BHV-1400 in IgA nephropathy and BHV-1300 in Graves' disease. Management anticipates a transformative second half of 2026, with topline data expected for opakalim in epilepsy and taldefgrobep alfa in obesity, alongside continued progress in oncology and neuroscience programs.

•6mo ago