Biohaven Ltd.

Biohaven and SK Biopharmaceuticals have announced a global licensing agreement for opakalim, Biohaven's lead epilepsy candidate, in a deal worth up to $795 million plus royalties. Under the agreement, SK Biopharmaceuticals obtains exclusive worldwide rights to Biohaven's Kv7 ion channel platform, while Biohaven receives $400 million in near-term cash, including $350 million at closing and $50 million in 2027. The deal also includes up to $150 million in development and regulatory milestones, with tiered royalties on US net sales ranging from the mid-teens to low twenties. SK Biopharmaceuticals will assume Kv7 program costs, including certain Knopp Biosciences obligations worth up to $245 million plus mid-single-digit royalties. The agreement follows positive proof-of-concept data in epilepsy, where opakalim extended the median time to a second seizure to 141 days versus 47 days on placebo, and 54% of patients in an open-label extension study saw at least a 50% reduction in seizure frequency. Biohaven's CEO stated the deal demonstrates the company's ability to monetize its pipeline through partnerships, providing non-dilutive cash to fund other programs such as BHV-1300 and BHV-1400. The pivotal RISE3 trial results are expected in the second half of 2026.

Biohaven has appointed John Yetimoglu to its Board of Directors, effective immediately. Yetimoglu is the founder and Chief Investment Officer of Infinitum, an investment firm specializing in semiconductors, videogaming, and next-generation AI application platforms, and serves as a director on the board of Groq, a leader in AI inference computing. His appointment brings frontier AI and technology-investing expertise to Biohaven as the company advances AI-enabled approaches to drug development. Biohaven expects the convergence of biology, data, and computation to drive the next wave of medical breakthroughs, and Yetimoglu's perspective is intended to strengthen the Board's strategic oversight in these areas.

Biohaven has completed enrollment in RISE3, a pivotal Phase 2/3 study evaluating its selective Kv7.2/7.3 activator opakalim for refractory focal epilepsy, with top-line results expected in the second half of 2026. The randomized, double-blind, placebo-controlled trial enrolled adults with refractory focal onset seizures who were taking one to three concurrent antiseizure medicines, randomizing them to 75 mg or 50 mg of opakalim or placebo once daily for an eight-week treatment period. In an ongoing open-label extension study, 54% of participants on opakalim 75 mg once daily achieved at least a 50% reduction in seizure frequency over any consecutive six months compared to pre-randomization baseline, with a markedly lower incidence of nervous system adverse events such as 5% dizziness and 4% fatigue. Approximately 95% of participants who reached the end of the double-blind treatment period in the pivotal RISE2 and RISE3 studies completed it, and about 95% of those rolled over into the optional open-label extension, reflecting favorable patient experience.

Biohaven 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 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. The randomized, double-blind, placebo-controlled study will evaluate BHV-1300 in approximately 300 adults, with the primary objective of assessing restoration of normal thyroid function at 26 weeks without antithyroid drugs. Phase 1b data showed greater than 80% reduction of pathogenic TSHR autoantibodies and rapid normalization of free T4 and free T3.

Biohaven Ltd. shares climbed 14.22 percent on Monday to close at $15.50 as investors positioned ahead of the initiation of two clinical studies by the end of the month. The company plans to begin studies for BHV-1510 in advanced or metastatic epithelial tumors and BHV-1530 in urothelial cancer and other tumors. Pivotal studies for BHV-1400 in IgAN and BHV-1300 in Graves' disease are expected to start in the middle of the year. In the first quarter, Biohaven reduced its net loss by 41 percent to $130.5 million from $221.7 million a year earlier, though it has yet to generate revenue.