New Haven, Connecticut, U.S., and Osaka, Japan, October 8, 2026
Biohaven Ltd. has entered into a strategic licensing and collaboration agreement with Ono Pharmaceutical Co., Ltd. to develop and commercialize its investigational extracellular immunoglobulin G (IgG) degrader portfolio in Japan, South Korea, Taiwan and member countries of the Association of Southeast Asian Nations (ASEAN). The agreement covers BHV-1300, BHV-1310 and BHV-1320, with BHV-1300 serving as the lead candidate and currently being evaluated in a Phase 3 clinical trial for Graves’ disease. Under the agreement, Ono will receive exclusive development and commercialization rights to the licensed candidates in the specified territories, while Biohaven retains rights in other markets, including the United States, Europe and China. Biohaven is eligible to receive up to $100 million in near-term payments, comprising an $80 million upfront payment and an additional $20 million upon achievement of a milestone anticipated within one year. The agreement also includes royalties of approximately 20% on net sales of licensed products by Ono in the designated territories. The collaboration marks Biohaven’s first regional partnership for its extracellular protein degradation technology and aims to combine its drug discovery platform with Ono’s regional development and commercialization capabilities.
BHV-1300 Advances as a Potential Graves’ Disease Therapy
BHV-1300 is an investigational small-molecule extracellular IgG degrader designed to remove selected IgG antibodies associated with immune-mediated diseases. The candidate uses Biohaven’s proprietary MoDE™ platform to direct targeted proteins toward the liver’s natural clearance mechanisms. The approach is intended to reduce disease-driving antibodies while preserving certain components of the immune system. Graves’ disease, the lead indication for BHV-1300, is an autoimmune condition in which antibodies targeting the thyroid-stimulating hormone receptor (TSHR) can cause excessive thyroid hormone production. According to Biohaven, a Phase 1b study in patients with Graves’ disease showed substantial reductions in pathogenic TSHR autoantibodies, rapid normalization of free triiodothyronine (T3) and free thyroxine (T4), and improvements in patient symptoms. The company also reports that the treatment selectively spares IgG3, an antibody subclass involved in immune protection. In ongoing Phase 1 studies, subcutaneous BHV-1300 has produced reductions in total IgG of up to 87%, with a favorable safety and tolerability profile reported to date. These findings are preliminary and do not establish the candidate’s efficacy or safety for regulatory approval. BHV-1300 is currently in Phase 3 development for Graves’ disease, where further clinical evidence will be needed to establish its potential therapeutic benefit.
Biohaven and Ono Expand IgG Degrader Development
The licensing agreement includes BHV-1310 and BHV-1320, next-generation IgG degraders designed to broaden the development potential of Biohaven’s MoDE portfolio across IgG-mediated diseases. The platform uses bispecific small molecules that bind a disease-associated target and direct it toward the liver through the asialoglycoprotein receptor (ASGPR), facilitating degradation through the body’s endosomal and lysosomal pathways. This strategy is designed to harness natural protein-clearance processes rather than relying exclusively on conventional antibody-blocking approaches. Biohaven’s technology originated from research conducted in the laboratory of Dr. David Spiegel at Yale University and has since been advanced into clinical development by the company. The platform is intended to offer rapid and adjustable reductions in targeted proteins, with subcutaneous administration designed to support convenient treatment delivery. Ono will lead development and commercialization activities in the licensed territories, leveraging its expertise in pharmaceutical research and regional market operations. The partnership also gives Ono access to a developing portfolio of immune-modulating candidates, aligning with its focus on immunology and inflammation. Biohaven retains all rights to the portfolio outside the licensed territories, preserving opportunities for development and commercialization in other global markets.
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$100 Million Deal Strengthens Global Commercial Strategy
The collaboration provides Biohaven with potential near-term financial support while establishing a regional commercialization pathway for its IgG degrader candidates. The agreed $80 million upfront payment, the potential additional $20 million milestone payment and approximately 20% royalties on net sales in the licensed territories form the main financial components disclosed by the companies. The milestone payment depends on achievement of the specified condition and is anticipated within one year of the agreement. For Biohaven, the deal represents an opportunity to advance its immunology pipeline while retaining rights to the technology in major markets outside Asia. For Ono, the agreement expands its late-stage and emerging development portfolio in immune-mediated diseases, beginning with BHV-1300 for Graves’ disease. Nevertheless, the timing of future development, regulatory submissions and commercialization will depend on clinical results, regulatory decisions and other program requirements. The agreement represents a significant strategic step for extracellular IgG degradation technology, but the licensed candidates remain investigational and their future clinical and commercial potential has yet to be fully established.
Source: Biohaven, Ono Pharmaceutical press release
