BHV-1300

Nov. 5, 2026: Biohaven Ltd. (NYSE: BHVN) reported progress in its Graves’ disease program, including ongoing enrollment in the pivotal Phase 3 trial of BHV-1300 and three presentations at the 2026 American Thyroid Association meeting (Nov. 4-7, Philadelphia).

BHV-1300: The Phase 3 randomized, double-blind, placebo-controlled study (NCT07661056) is enrolling about 300 adults with Graves’ disease at more than 55 U.S. and Canadian sites, with additional activations planned through 4Q26 and 1Q27. The primary evaluation is restoration of normal thyroid function at week 26 without an antithyroid drug. In Phase 1b, weekly subcutaneous 1000 mg BHV-1300 reduced pathogenic anti-TSHR-IgG1 by about 80% by week 12, normalized free T4 at a median of 3 weeks and free T3 at a median of 5 weeks in patients still hyperthyroid on antithyroid drugs, while sparing IgG3.

MoDE collaboration: In October 2026, Ono Pharmaceutical licensed the MoDE pan-IgG degrader portfolio in Japan, South Korea, Taiwan, and ASEAN, led by BHV-1300 plus BHV-1310 and BHV-1320. Terms include $80 million upfront, a potential $20 million milestone within a year, and royalties of about 20%.

BHV-1440: A preclinical ATA poster showed this TRAP degrader reduced circulating anti-TSHR antibody in a mouse passive-transfer model within two hours, normalized elevated T4 by 24 hours, restored thyroid histology, and showed an average EC50 of 0.73 nM in primary human hepatocytes.