Biohaven Announces Progress Across Its Graves' Disease Program, Including Active Enrollment In Pivotal Phase 3 Trial Of BHV-1300 And Three Scientific Presentations At The American Thyroid Association Meeting; Phase 3 Trial Of BHV-1300 In Graves' Disease Is Enrolling At 55+ Active Sites In U.S. And Canada, With More Opening In UK, Japan, Australia And EU

Biohaven presents three posters at ATA, highlighting the patient experience, autoimmune biology of disease, and MoDE and TRAP platform, reflecting a research program built around a condition that remains strikingly understudied relative to its prevalence.
No new therapy has been approved for Graves' disease in more than seventy years. Antithyroid drugs, radioactive iodine and thyroidectomy manage thyroid hormone output; none removes the autoantibody that causes the disease.
Biohaven's Phase 3 trial of BHV-1300 in Graves' disease (NCT07661056) is enrolling at more than 55 active sites in the United States and Canada, with additional sites opening in Japan, UK, Australia, and EU. BHV-1300 is the first MoDE extracellular protein degrader to reach a pivotal study.
In a Phase 1b study, weekly subcutaneous BHV-1300 1000 mg produced mean reductions in pathogenic anti-TSHR-IgG1 autoantibodies of approximately 80% by week 12, with normalization of free T4 at a median of 3 weeks and free T3 at a median of 5 weeks in patients who were hyperthyroid despite antithyroid drug therapy, while sparing IgG3.
A pivotal trial, a key collaboration expanding the technology into Asia, and three scientific posters at ATA underscore the company's progress in advancing its Graves' disease program—from molecular science and autoimmune biology to the patient experience—in a disease that has seen no new therapy in seventy years.