BHV-1300 is the first MoDE™ extracellular protein degrader to enter a pivotal trial, pioneering a new class of precision immunology medicines that eliminate the disease-driving antibodies at the root of autoimmune disease.
BHV-1300 targets the TSHR-IgG1 autoantibody that drives Graves' disease, not the thyroid gland itself. This is a fundamental shift from existing treatment approaches.
Exclusively licensed from Yale University, Biohaven's BHV-1300's pivotal trial marks the vanguard of a broader platform: multiple next-generation MoDE and TRAP™ extracellular protein degraders advancing across the pipeline to address immunologic disease.
NEW HAVEN, Conn., June 29, 2026 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) today announced enrollment of the first patient in the pivotal Phase 3 trial of BHV-1300 for Graves' disease. BHV-1300 is the first MoDE extracellular protein degrader, a novel small molecule IgG1, 2 and 4 degrader that harnesses the body's own clearance machinery to eliminate the IgG1 TSHR autoantibody driving Graves' disease. In over 70 years, no new therapy has been approved for Graves' disease. BHV-1300 is designed to change the treatment landscape for this autoimmune disease.
Beth Emerson, MD, MBA, Executive Medical Director at Biohaven and Lead for the Graves' disease clinical trial, commented, "The enrollment of the first patient in this pivotal trial marks an important moment for the Graves' disease community. For decades, physicians have relied on treatments that either suppress thyroid function or destroy the gland. BHV-1300 represents an opportunity to bring forward a disease modifying therapy, targeting the underlying cause of Graves' disease, thyroid eye disease, and pretibial myxedema rather than addressing the downstream complications."
BHV-1300 is the lead molecule from Biohaven's MoDE platform — exclusively licensed from Yale University where the technology originated in the Spiegel Lab and advanced by the Biohaven discovery and clinical teams — which directs disease-driving proteins to the body's own natural clearance pathways for selective elimination. The Phase 3 program is grounded in Phase 1b data demonstrating:
Greater than 80% reduction of pathogenic TSHR autoantibodies
Rapid normalization of free T4 and free T3 in patients with Graves' hyperthyroidism
Improvements in hallmark symptoms of Graves' disease
Preservation of IgG3, IgA, IgM, and IgE
Favorable safety and tolerability
BHV-1300 is the first extracellular degrader to reach a pivotal trial, opening the door to an entirely new therapeutic modality in precision immunology.