Full Press Release Details
• BHV-1300 demonstrated deep, rapid, and sustained lowering of pathogenic TSHR autoantibodies (TSHR-IgG1) in patients with Graves' hyperthyroidism receiving 1000 mg SC weekly, with mean reductions in TSHR-IgG1exceeding >80% over the 12-week study.Participants with Graves' overt hyperthyroidism, confirmed by elevated baseline thyroid tests despite being treated with anti-thyroid drug therapy (ATD), experienced normalization of thyroid hormones within weeks;T4 normalization occurring at a median of 3 weeks and T3 at a median of 5 weeks after the first administration of BHV-1300.These preliminary patient data from an ongoing Phase 1b study highlight deep lowering of TSHR-IgG1 with BHV-1300 as a potentially disease-modifying approach to Graves' disease.
• BHV-1400 achieved rapid, deep, selective, and sustained lowering of Gd-IgA1 in patients with IgA nephropathy (IgAN), differentiating Biohaven's leading TRAP degrader from the complement and BAFF/APRIL inhibitor competition.Participants with IgAN administered BHV-1400 showed a rapid, > 60% mean reduction of Gd-IgA1within hours, and a 70% mean reduction of within the first one-month of dosing. Observed reductions in Gd-IgA1 were deeper than has been reported with BAFF/APRIL inhibitors, APRIL-inhibitors, and CD38 inhibitors at these early time points.Preliminary observations also demonstrated an increase in eGFR, decrease in spot UPCR, and a decrease in hematuria with one month or less of dosing.BHV-1400 brings precision immunology to the treatment landscape of IgAN as it was rationally designed to selectively remove galactose-deficient IgA1 (Gd-IgA1), the pathogenic antibody driver of the disease while sparing healthy antibodies IgA, IgG, IgE, and IgM.Designed to target the disease driver while preserving healthy immunoglobulins, the complement system, and cell-mediated and humoral immunity, BHV-1400 offers a differentiated approach to current immunosuppressive therapies approved or in development.
• Both BHV-1300 and BHV-1400 continue to demonstrate the paradigm shifting potential of its extracellular degrader platform to target pathogenic antibodies causing disease. BHV-1300 and BHV-1400 show a differentiated safety profile with no clinically significant increases in cholesterol, decreases in albumin, or increases in ALT, AST, or bilirubin. Most AEs were mild and self-resolving, there were no drug discontinuations throughout the patient studies, and no serious or severe AEs.
• Pivotal Phase 3 trials in Graves' Disease and IgA Nephropathy to initiate in the coming weeks by mid-2026. Both trials use a patient friendly, simple to self-administer autoinjector for BHV-1300 and BHV-1400.
• Participants with Graves' overt hyperthyroidism, confirmed by elevated baseline thyroid tests despite being treated with anti-thyroid drug therapy (ATD), experienced normalization of thyroid hormones within weeks;T4 normalization occurring at a median of 3 weeks and T3 at a median of 5 weeks after the first administration of BHV-1300.
• These preliminary patient data from an ongoing Phase 1b study highlight deep lowering of TSHR-IgG1 with BHV-1300 as a potentially disease-modifying approach to Graves' disease.
• Participants with IgAN administered BHV-1400 showed a rapid, > 60% mean reduction of Gd-IgA1within hours, and a 70% mean reduction of within the first one-month of dosing. Observed reductions in Gd-IgA1 were deeper than has been reported with BAFF/APRIL inhibitors, APRIL-inhibitors, and CD38 inhibitors at these early time points.
• Preliminary observations also demonstrated an increase in eGFR, decrease in spot UPCR, and a decrease in hematuria with one month or less of dosing.
• BHV-1400 brings precision immunology to the treatment landscape of IgAN as it was rationally designed to selectively remove galactose-deficient IgA1 (Gd-IgA1), the pathogenic antibody driver of the disease while sparing healthy antibodies IgA, IgG, IgE, and IgM.
• Designed to target the disease driver while preserving healthy immunoglobulins, the complement system, and cell-mediated and humoral immunity, BHV-1400 offers a differentiated approach to current immunosuppressive therapies approved or in development.
NEW HAVEN, Conn.,May 27, 2026/PRNewswire/ -- Biohaven Ltd. (NYSE:BHVN) ("Biohaven") a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies with the potential to transform autoimmune diseases today reported compelling results regarding its proprietary extracellular MoDE™ (BHV-1300) and TRAP™ (BHV-1400) degrader platform. The new patient data from its BHV-1300 MoDE degrader for Graves' disease and BHV-1400 TRAP degrader for IgA nephropathy is being presented today at Biohaven's R&D and Analyst Day as part of the 2026 Yale Innovation Summit at the Yale School of Management in New Haven, Connecticut.