Biohaven Ltd. filed a third-quarter 2026 business update on October 29, 2026, disclosing two major licensing agreements, an FDA acceptance of a troriluzole resubmission, and a partial clinical hold on new opakalim enrollment.

Key Highlights

  • SK Biopharmaceuticals deal: Biohaven disclosed an exclusive global license for its Kv7 ion channel platform, including opakalim (BHV-7000), providing $400 million in near-term cash consideration, consisting of $350 million at closing and $50 million one year after closing, plus up to $150 million in development and regulatory milestones.
  • Ono Pharmaceutical agreement: Biohaven entered an exclusive license with Ono for its MoDE pan IgG degrader portfolio in Japan, South Korea, Taiwan and ASEAN, with up to $100 million in near-term payments, including an $80 million upfront payment received to date and a $20 million milestone anticipated within a year of signing.
  • FDA NDA acceptance: The FDA accepted Biohaven's new drug application resubmission for Vyglxia (troriluzole) in spinocerebellar ataxia, assigning a user fee goal date in the first quarter of 2027.
  • Partial clinical hold: On September 4, 2026, the FDA issued a partial clinical hold letter pausing new enrollment in opakalim trials pending additional nonclinical studies related to a specific metabolite observed in rodent testing; dosing of more than 600 already-randomized patients is allowed to continue.
  • BHV-1300 Phase 3 ongoing: Enrollment is continuing in the pivotal Phase 3 trial of BHV-1300 in Graves' disease, with more than 50 sites activated in the US and Canada following a June 2026 study initiation.
  • HSR waiting period expired: The applicable HSR waiting period for the SK Biopharmaceuticals license agreement expired on October 28, 2026, according to the filing.

Biohaven's Q3 2026 Pipeline and Partnership Developments

According to the filing, Biohaven (NYSE:BHVN) reported two significant licensing transactions during and after the third quarter ended September 30, 2026. In August 2026, the company entered a license agreement with SK Biopharmaceuticals Co., Ltd. (SKBP) granting SKBP an exclusive, royalty-bearing, worldwide license to Biohaven's Kv7 ion channel platform. The filing states Biohaven is eligible to receive tiered royalties ranging from the mid-teens to low twenties on U.S. net sales of opakalim and a mid-single digit royalty on net sales outside the U.S. SKBP will assume responsibility for Kv7 program costs going forward, including certain specified milestone and royalty obligations to Knopp Biosciences.

In October 2026, Biohaven disclosed a separate strategic licensing and collaboration agreement with Ono Pharmaceutical Co., Ltd., covering the MoDE pan IgG degrader portfolio, including BHV-1300 and next-generation follow-on degraders BHV-1310 and BHV-1320, in Japan, South Korea, Taiwan and the ASEAN countries. The filing states that royalties of approximately 20 percent on net sales by Ono in the licensed territory are included in the arrangement, and that Biohaven retains all rights outside that territory, including in the U.S., Europe and China.

On the regulatory front, the filing disclosed that the FDA communicated it considers the troriluzole resubmission a complete response to the November 4, 2025 action letter and plans to convene a Peripheral and Central Nervous System Advisory Committee meeting. Separately, the company reported that a partial clinical hold letter was issued on September 4, 2026, specifically pausing new patient enrollment in opakalim studies while nonclinical studies related to a metabolite observed in rodent testing are completed. The filing notes that the RISE 3 study is fully enrolled and randomized, with topline data "on track for the second half of 2026," and characterizes the significance of the nonclinical metabolite findings to humans as "uncertain."

What Was Disclosed

Biohaven reported a third-quarter 2026 business update covering two major exclusive licensing deals totaling up to $500 million in near-term payments, FDA acceptance of the troriluzole NDA resubmission with a Q1 2027 user fee goal date, and an FDA partial clinical hold on new opakalim enrollment issued September 4, 2026.