BHV-1300

June 29, 2026: Biohaven Ltd. (NYSE: BHVN) announced enrollment of the first patient in its pivotal Phase 3 trial of BHV-1300 for Graves’ disease. BHV-1300 is described as the first MoDE™ extracellular protein degrader to enter a pivotal study and is a small-molecule IgG1/2/4 degrader intended to eliminate the pathogenic TSHR-IgG1 autoantibody (TRAb) that drives Graves’ disease, rather than targeting the thyroid gland.

The Phase 3 study (NCT07661056) is randomized, double-blind, placebo-controlled, and planned to enroll ~300 adults. The primary objective is restoration of normal thyroid function at 26 weeks in the absence of an antithyroid drug. BHV-1300 is administered subcutaneously via an autoinjector designed for self-administration at home.

The program is supported by Phase 1b/Phase 1 expansion data cited in the release showing >80% reduction of TSHR autoantibodies, rapid normalization of free T4 and free T3, symptom improvements, preservation of IgG3/IgA/IgM/IgE, and favorable safety/tolerability; preliminary ongoing data referenced include n=3 in the expansion cohort at 1,000 mg SC weekly.