Biohaven's Q3 update: FDA accepts Vyglxia filing, SK Biopharmaceuticals deal pending

Biohaven Ltd. reported third-quarter 2026 results and business updates on October 29, 2026, covering regulatory, licensing and clinical developments across its pipeline.

The FDA accepted Biohaven's new drug application resubmission for Vyglxia (troriluzole) in spinocerebellar ataxia and the agency communicated that it considers the resubmission a complete response to the November 4, 2025 action letter, and has assigned a user fee goal date in the first quarter of 2027¹. The FDA plans to convene a meeting of the Peripheral and Central Nervous System Advisory Committee, with the meeting date still to be announced.¹

On the Kv7 platform, in August 2026 Biohaven entered a license agreement with SK Biopharmaceuticals Co., Ltd. under which, upon closing, SKBP will hold an exclusive, royalty-bearing, worldwide license to Biohaven's Kv7 ion channel platform, including opakalim (BHV-7000).¹ The deal provides $400 million in cash, split between $350 million at closing and $50 million a year later, plus up to $150 million in milestones.¹ The HSR waiting period expired October 28, 2026, clearing the way for closing conditions to be completed.¹ Separately, the FDA issued a partial clinical hold letter on September 4, 2026, pausing new enrollment in opakalim studies pending additional nonclinical data, though the hold applies only to new patients.¹ The company said RISE 3 is unaffected, as it is fully enrolled and dosing, with topline data still expected in the second half of 2026.¹

In immunology, Biohaven licensed its MoDE IgG degrader portfolio, led by BHV-1300, to Ono Pharmaceutical for Japan, South Korea, Taiwan and ASEAN.¹ Terms include up to $100 million near-term, comprising $80 million already received and a $20 million milestone, plus roughly 20% royalties.¹ BHV-1300's Phase 3 Graves' disease trial continues enrolling, and BHV-1400's pivotal IgA nephropathy study remains targeted to start in the fourth quarter of 2026.¹

In oncology, Biohaven signed a clinical supply agreement with Regeneron for Libtayo to support BHV-1530 combination cohorts¹, which began enrolling in Q3 2026. In metabolic disease, amended trial design for taldefgrobep alfa pushed topline obesity data to the second half of 2027.¹

On cash, Biohaven held approximately $164.0 million in cash, cash equivalents, marketable securities and restricted cash as of September 30, 2026¹, with $80.0 million received from Ono on October 20, 2026, and an additional $350.0 million expected from SKBP upon closing.¹