On August 10, 2026 Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), 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 financial results for the second quarter ended June 30, 2026, and provided a review of recent accomplishments and anticipated upcoming developments.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "What excites me most about Biohaven today is that we’re no longer talking about scientific promise—we’re watching new therapeutic approaches begin to work in patients. This year we’ve crossed important milestones across our portfolio, including advancing BHV-1300 into pivotal development for Graves’ disease and generating compelling patient data from both our Graves’ disease and IgA nephropathy programs. We believe our MoDE and TRAP platforms are doing something fundamentally different: selectively removing the proteins that drive disease while preserving normal immune function. If these data continue to translate into larger studies, extracellular protein degradation has the potential to reshape how autoimmune diseases are treated."
Dr. Coric continued, "Opakalim represents another example of our commitment to solving difficult biological problems with precision. For decades, patients with epilepsy have often had to choose between seizure control and living with burdensome central nervous system side effects like somnolence, dizziness, and cognitive impairment. Our goal is to change that equation. Across studies to date, opakalim has consistently demonstrated the potential to deliver meaningful seizure reduction with a differentiated tolerability profile from existing therapies. As we approach our pivotal readout later this year, we believe we have the opportunity to introduce an important new treatment option for patients who deserve both seizure control and the ability to fully participate in their everyday lives."
Second Quarter 2026 and Recent Business Highlights
Presented new patient data from the MoDE platform in Graves’ disease; initiated pivotal study: In May 2026, the Company presented new clinical data from an ongoing Phase 1b study of BHV-1300 in patients with Graves’ disease. In the study, weekly administration of BHV-1300 1000 mg subcutaneously achieved mean reductions of pathogenic TSHR-IgG1 autoantibodies of greater than 80% by week 12 in patients with Graves’ hyperthyroidism. Among participants with elevated thyroid hormones despite concurrent anti-thyroid drug therapy, normalization of free T4 occurred at a median of 3 weeks, and normalization of free T3 occurred at a median of 5 weeks after the first administration of BHV-1300. To date, BHV-1300 has been safe and well-tolerated through 12 weeks of dosing, with most AEs mild and self-resolving, no SAEs, no clinically significant increases in cholesterol or ALT/AST/bilirubin, no clinically significant reductions in albumin, and no clinically significant reductions in IgG3, IgA, IgE, or IgM relative to baseline. Based upon these Phase 1b results, we have initiated a pivotal trial of BHV-1300 in Graves’ disease and expect to pursue additional follow-on studies in other autoimmune diseases. The Phase 3 study is designed to evaluate the ability of BHV-1300 to rapidly and selectively eliminate disease-causing autoantibodies while preserving the remainder of the immune system.
Presented additional patient data supporting the TRAP degrader platform in IgA nephropathy: In May 2026, the Company reported updated Phase 1b data from our ongoing study of BHV-1400 in patients with IgAN. BHV-1400 administered subcutaneously achieved mean reductions of pathogenic Gd-IgA1 of greater than 60% within 48 hours and approximately 70% within the first month of dosing. These reductions were deeper than those reported for BAFF/APRIL inhibitors, APRIL inhibitors, and CD38 inhibitors at comparable early time points. Reductions in Gd-IgA1 were associated with increases in eGFR, decreases in spot UPCR, and resolution of hematuria. Effects were selective, with no clinically significant reductions in other immunoglobulins (IgA, IgG, IgE, or IgM). To date, BHV-1400 has been safe and well-tolerated throughout one month of dosing, with most AEs mild and self-resolving, no SAEs, and no clinically significant increases in ALT, AST, or bilirubin. A pivotal study is expected to initiate in 2H 2026.
Continued advancement of Biohaven’s extracellular degrader pipeline: Biohaven continues to expand its leadership in extracellular targeted protein degradation with multiple MoDE and TRAP programs advancing across autoimmune diseases. In addition to ongoing development of BHV-1300 in Graves’ disease and BHV-1400 in IgA nephropathy, the Company continues advancing additional degrader candidates targeting IgG4-mediated disease, PLA2R autoantibodies, pro-insulin autoantibodies and other pathogenic extracellular proteins, broadening the potential impact of its proprietary platform.
Presented clinical data update with opakalim (BHV-7000) across multiple epilepsy types: In May 2026 at the Company’s annual R&D Day, the Company reported new clinical data for opakalim, a selective Kv7 activator, demonstrating durable seizure control and a differentiated tolerability profile across multiple epilepsy populations. In a proof-of-concept study in idiopathic generalized epilepsy (IGE), with a time-to-event design, the median time to the second generalized tonic-clonic seizure was 141 days with opakalim versus 47 days with placebo, with 33% of treated participants completing the 24-week double-blind period without a second seizure. Updated data from the ongoing open-label extension study in focal epilepsy showed that 54% of participants achieved a ≥50% reduction in seizure frequency over any consecutive six-month treatment period (n>100), while opakalim continued to demonstrate a favorable safety profile with a low incidence of CNS adverse events. Topline results from the Phase 2/3 RISE3 trial in focal epilepsy are expected during 2H 2026.
Continued advancement of Biohaven’s oncology portfolio: In July 2026, the Company announced that new data on BHV-1530, its FGFR3-directed antibody-drug conjugate (ADC) using a novel topoisomerase I (TopoIx) payload, will be presented at the ESMO (Free ESMO Whitepaper) Congress 2026. The new Phase 1 data will provide a clinically meaningful update to the early Phase 1 data initially disclosed at Biohaven’s R&D Day in May 2026 and will include signals of clinical activity demonstrated in the ongoing Phase 1, open-label, dose-escalation study of BHV-1530 in patients with advanced solid tumors. The data from May 27, 2026, showed early signs of antitumor activity in patients with both FGFR3-altered and wild-type overexpressing tumors, and across multiple tumor types. The Company also announced a new clinical supply agreement with Regeneron to evaluate BHV-1530 in combination with Libtayo. 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.
Completed enrollment in Phase 2 obesity study with taldefgrobep alfa: Taldefgrobep alfa targets the myostatin/activin pathway with the goal of producing high-quality weight loss while preserving lean muscle mass. Unlike therapies designed primarily to maximize weight reduction, Biohaven believes preservation of skeletal muscle may translate into greater metabolic health, improved physical function, and more durable long-term treatment outcomes.
Reported first-in-human (FIH) dosing of oral PKM2 modulator, BHV-8100, targeting metabolic restoration and immunomodulation: In June 2026, the Company announced the initiation of FIH dosing for BHV-8100, its oral, brain-penetrant pyruvate kinase M2 isoform (PKM2) modulator. PKM2 modulation offers a potential new paradigm for treating large, underserved, and high-value indications in neurology, ophthalmology, and immunology and exhibits robust beneficial effects across a spectrum of preclinical models of Alzheimer’s, and multiple sclerosis, specifically by restoring metabolic deficits, reducing inflammation and neurodegeneration, and enhancing remyelination.
Advanced Parkinson’s disease program with BHV-8000: Enrollment continues in the Company’s global pivotal Phase 2/3 study evaluating BHV-8000, its orally administered, brain-penetrant, highly selective TYK2/JAK1 inhibitor for early Parkinson’s disease. BHV-8000 is designed to modulate neuroinflammation, a central driver of disease progression, and peripheral immune dysregulation.
Expected Upcoming Milestones:
We believe Biohaven is well positioned to achieve significant milestones in the second half of 2026 across numerous programs:
Selective Kv7 Ion Channel Activator (Opakalim):
Continue two Phase 2/3 studies in focal epilepsy; topline results for the first study expected in 2H 2026.
Myostatin-Activin Pathway Inhibitor (Taldefgrobep alfa):
Completed enrollment in Phase 2 study in obesity in 1Q 2026.
Lead TRAP and MoDE Extracellular Protein Degraders (BHV-1400 and BHV-1300)
BHV-1300: Continue enrolling patients in ongoing Phase 3 study in Graves’ disease following June 2026 study initiation. The study is a randomized, double-blind, placebo-controlled study in approximately 300 adults with Graves’ hyperthyroidism evaluating normalization of T3, T4, and TSH at 26 weeks absent an antithyroid drug.
BHV-1400: Pivotal study initiation in IgAN study targeted for 2H 2026.
Capital Position:
Cash, cash equivalents, marketable securities and restricted cash as of June 30, 2026, totaled approximately $270.5 million.
Second Quarter 2026 Financial Highlights:
Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $100.8 million for the three months ended June 30, 2026, compared to $184.4 million for the three months ended June 30, 2025. The decrease of $83.6 million was primarily due to decreases in direct program spend and preclinical spend in 2026 as compared to the same period in the prior year. The decrease in direct program spend was largely due to our strategic reprioritization of programs, which was implemented in the fourth quarter of 2025, as well as one-time developmental milestones recorded during the three months ended June 30, 2025 of $15.0 million and $10.0 million for our BHV-8000 and BHV-1530 programs, respectively. Non-cash share-based compensation expense was $12.0 million for the three months ended June 30, 2026, a decrease of $1.1 million as compared to the same period in 2025.
General and Administrative (G&A) Expenses: G&A expenses, including non-cash share-based compensation costs, were $24.1 million for the three months ended June 30, 2026, compared to $27.3 million for the three months ended June 30, 2025. The decrease of $3.2 million was primarily due to decreased legal costs and employee costs, including non-cash share based compensation expense. Non-cash share-based compensation expense was $7.2 million for the three months ended June 30, 2026, a decrease of $0.5 million as compared to the same period in 2025.
Other (Expense) Income, Net: Other (expense) income, net was other expense, net of $12.0 million for the three months ended June 30, 2026, compared to other income, net of $13.8 million for the three months ended June 30, 2025. The decrease of $25.8 million was primarily due to increased non-cash losses during the three months ended June 30, 2026 related to changes in fair value of our notes payable liability under the Note Purchase Agreement with Beetlejuice SA LLC, an affiliate of Oberland Capital Management LLC, entered into during the second quarter of 2025 (the NPA), and gains recorded during the three months ended June 30, 2025 for the non-cash changes in fair value of our forward contracts and derivative liabilities recorded in connection with the amendment to our Membership Interest Purchase Agreement with Knopp Biosciences LLC in May 2024 (the Knopp Amendment).
Net Loss: Biohaven reported a net loss for the three months ended June 30, 2026 of $137.3 million, or $0.91 per share, compared to $198.1 million, or $1.94 per share, for the same period in 2025. Non-GAAP adjusted net loss for the three months ended June 30, 2026 was $118.1 million, or $0.78 per share, compared to $166.4 million, or $1.63 per share, for the same period in 2025. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges and losses from the change in fair value of derivatives. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below.
(Press release, Biohaven Pharmaceutical, AUG 10, 2026, View Source [SID1234669912])