Biohaven Q3 Loss Narrows as FDA Accepts Vyglxia NDA Resubmission

Biohaven Ltd. (BHVN ) on October 29, 2026, reported a net loss of $129.3 million, or $0.86 per share, for the third quarter ended September 30, 2026, compared with a net loss of $173.4 million, or $1.64 per share, in the same period of 2025, and said the U.S. Food and Drug Administration has accepted for review the company’s resubmitted new drug application for Vyglxia (troriluzole) in spinocerebellar ataxia. In its third-quarter 2026 results announcement, the company also detailed an exclusive regional license granted to Ono Pharmaceutical for its MoDE IgG degrader portfolio and progress toward closing a $400 million worldwide license of its Kv7 ion channel platform to SK Biopharmaceuticals.

Third-Quarter 2026 Financial Results

Research and development expenses, including non-cash share-based compensation, were $101.9 million for the quarter, compared with $141.2 million a year earlier. The company attributed the $39.3 million decrease primarily to lower direct program spend and preclinical spend, with the reduction in direct program spend largely reflecting a strategic reprioritization of programs implemented in the fourth quarter of 2025. Non-cash share-based compensation within research and development was $12.1 million, a decrease of $1.9 million from the prior-year quarter.

General and administrative expenses were $24.6 million, compared with $28.2 million a year earlier, a $3.6 million decrease the company attributed primarily to lower employee costs. Other expense, net was $2.9 million, compared with $3.8 million, a $0.9 million decrease the company attributed primarily to lower non-cash losses from changes in the fair value of its notes payable liability.

Non-GAAP adjusted net loss was $110.7 million, or $0.73 per share, compared with $155.9 million, or $1.47 per share, in the prior-year quarter. The company said the non-GAAP measures exclude non-cash share-based compensation and gains and losses from changes in the fair value of derivatives, that they are not an alternative to GAAP measures, and that a reconciliation is included in the release.

For the nine months ended September 30, 2026, the net loss was $397.1 million, or $2.65 per share, compared with $593.3 million, or $5.74 per share, in the same period of 2025. Weighted average common shares outstanding were 151.0 million for the quarter, compared with 105.8 million a year earlier.

Cash, cash equivalents, marketable securities and restricted cash totaled approximately $164.0 million as of September 30, 2026. Biohaven received an $80.0 million upfront payment from Ono on October 20, 2026, and said it will receive an additional $350.0 million from SK Biopharmaceuticals upon the closing of that agreement. The balance sheet showed total assets of $263.7 million, compared with $451.4 million at December 31, 2025, notes payable of $264.3 million, and a shareholders’ deficit of $98.2 million, compared with shareholders’ equity of $52.1 million at the end of 2025.

Licensing and Regulatory Developments

The FDA informed Biohaven that the Vyglxia resubmission has been accepted for review and that the agency considers it a complete response to its November 4, 2025 action letter. The agency assigned a user fee goal date in the first quarter of 2027 and plans to convene a meeting of the Peripheral and Central Nervous System Advisory Committee, with the meeting date to be announced. Biohaven said the resubmission included new positive supportive analyses.

In October 2026, Biohaven entered into a strategic licensing and collaboration agreement under which Ono Pharmaceutical obtained an exclusive license to develop and commercialize the company’s MoDE pan IgG degrader portfolio, led by BHV-1300 and including next-generation follow-on degraders BHV-1310 and BHV-1320, in Japan, South Korea, Taiwan and the countries of the Association of Southeast Asian Nations. Terms provide Biohaven up to $100 million in near-term payments, consisting of the $80 million upfront payment received to date and a $20 million payment upon achievement of a milestone anticipated within a year of signing, plus royalties of approximately 20 percent on Ono’s net sales in the licensed territory. Biohaven retains all rights to the portfolio outside the licensed territory, including in the U.S., Europe and China.

Chairman and Chief Executive Officer Vlad Coric described the Ono agreement as “the first ever regional collaboration for an extracellular protein degrader” and said it validates the potential of the company’s MoDE and TRAP platforms. Coric said the quarter “marked important progress in executing our strategy of building differentiated platforms and partnering them to create both near-term and long-term value.”

BHV-1300, an investigational small-molecule extracellular IgG degrader, is in a pivotal Phase 3 trial in Graves’ disease initiated in June 2026, with more than 50 sites activated for enrollment in the U.S. and Canada and additional site openings expected in Japan, Australia, the UK and the EU. According to the company, a Phase 1b study in patients with Graves’ disease showed BHV-1300 produced deep reduction in the pathogenic autoantibody to the TSH receptor, rapid normalization of free T3 and free T4, and improvement in patient symptoms, with selective sparing of IgG3.

Under an August 2026 agreement, SK Biopharmaceuticals will, upon closing, hold an exclusive, royalty-bearing, worldwide license to Biohaven’s Kv7 ion channel platform, including opakalim (BHV-7000) and other Kv7 compounds and products covered by the agreement. Terms provide Biohaven $400 million in cash consideration, with $350 million payable at closing and $50 million payable one year after closing, plus eligibility for up to $150 million in development and regulatory milestone payments. Biohaven is also eligible for tiered royalties ranging from the mid-teens to the low twenties on U.S. net sales of opakalim and a mid-single-digit royalty on net sales outside the U.S. SK Biopharmaceuticals will assume responsibility for Kv7 program costs going forward, including certain specified milestone and royalty obligations to Knopp Biosciences. The company said the HSR waiting period applicable to the agreement expired on October 28, 2026, allowing completion of the remaining closing conditions.

The FDA issued a partial clinical hold letter on September 4, 2026, instructing Biohaven to pause new enrollment in opakalim studies after determining there was insufficient information about a specific metabolite observed in rodent testing to assess its risk to human subjects. The hold applies to new patient enrollment only: dosing continues for more than 600 already-randomized patients across the program; the fully enrolled RISE 3 study remains on track for topline data in the second half of 2026; RISE 2 continues dosing with new enrollment paused pending nonclinical data expected in the coming weeks; and the open-label extension study continues dosing. Biohaven voluntarily instituted the same plan at its global sites outside the U.S. The company said the significance of the metabolite findings to humans is uncertain, that the findings may be specific to rodents, and that opakalim has generally been safe and well tolerated in clinical studies, with more than 1,200 participants dosed to date.

Elsewhere in the pipeline, Biohaven said it remains on track to initiate a pivotal Phase 3 trial of BHV-1400, a TRAP extracellular degrader targeting galactose-deficient IgA1, in IgA nephropathy during the fourth quarter of 2026, with planned regions including Japan and other Asia-Pacific markets, the U.S., Europe and Latin America. Phase 1 data for BHV-1530, the company’s FGFR3-directed antibody-drug conjugate, were selected for an oral presentation at the 38th EORTC-NCI-AACR Symposium in Barcelona, with the presentation scheduled for November 19, 2026, during the November 18 to 20 meeting. Combination cohorts evaluating BHV-1530 with Regeneron Pharmaceuticals’ (REGN ) anti-PD-1 antibody Libtayo (cemiplimab-rwlc) began enrolling in the third quarter of 2026 under a clinical supply agreement in which Biohaven sponsors and funds the trial and Regeneron provides Libtayo. The company reported early clinical activity for BHV-1530, including confirmed partial responses in heavily pretreated patients, with no dose-limiting toxicities and no FGFR inhibitor class toxicities observed. The BHV-1510 endometrial expansion cohort is ongoing, with enrollment completion anticipated in late 2026 to early 2027.

The Phase 2 obesity study of taldefgrobep alfa is being amended to add an assessment in combination with a GLP-1-based therapy, and the company said it now anticipates topline data from the monotherapy and combination portions of the trial in the second half of 2027. BHV-8000, an oral, brain-penetrant, selective TYK2/JAK1 inhibitor, is being evaluated in a global Phase 2/3 study in people with early-stage Parkinson’s disease, and BHV-8100, an oral, brain-penetrant pyruvate kinase M2 (PKM2) modulator, is in a first-in-human study.

In August 2026, the U.S. District Court for the District of Delaware entered judgment confirming a jury’s July 2026 finding that RA Capital and Avilar Therapeutics willfully and maliciously misappropriated a Yale University trade secret relating to the MoDE platform, formalizing a combined $4 million award to Yale and Biohaven; post-trial motions have been filed. Also in August 2026, the company appointed technology investor John Yetimoglu to its board of directors. Biohaven said it is collaborating with Bexorg, pairing that firm’s NeuroLens AI platform with whole-human-brain data generated on its BrainEx platform to help select neuroscience candidates and guide translational strategy; according to the company, NeuroLens evaluates assets against a data lake built from approximately 500 human brains and showed high positive and negative predictive values across 43 recently studied CNS programs.