AI Earnings Predictions for Biohaven Ltd. (BHVN)

EX-99.1

2 a2026q3bhvnearningsprex991.htm

EX-99.1

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Exhibit 99.1

Biohaven Reports Recent Business Developments and Third Quarter 2026 Financial Results

•The US Food and Drug Administration (FDA) accepted new drug application resubmission for Vyglxia (troriluzole) in spinocerebeller ataxia (SCA), user fee goal date 1Q27.

•Announced exclusive global license with SK Biopharmaceuticals Co., Ltd. for Kv7 ion channel platform, including opakalim (BHV-7000); providing $400 million in near-term cash consideration to Biohaven.

•Entered into exclusive license with Ono Pharmaceutical Co., Ltd. for Biohaven's MoDE pan IgG degrader portfolio, led by BHV-1300 in Phase 3 for Graves' disease, in Japan, South Korea, Taiwan and the ASEAN region; up to $100 million in near-term payments to Biohaven, including $80 million upfront received to date and eligible to receive another $20 million upon a milestone achievement anticipated within a year, plus royalties of approximately twenty percent on net sales in the licensed territory.

•Enrollment ongoing in pivotal Phase 3 trial of BHV-1300, a MoDE™ extracellular degrader targeting IgG, in Graves’ disease. More than 50 sites have been activated for enrollment in the US and Canada, with additional site openings expected in Japan, Australia, the UK and the EU.

•On track to initiate the pivotal Phase 3 trial of BHV-1400, a TRAP™ extracellular degrader targeting galactose-deficient IgA1 (Gd-IgA1), in IgA nephropathy (IgAN) during 4Q 2026. Planned regions include Japan and other Asia-Pacific regions (Australia, China, India, Taiwan and South Korea), United States, Europe (EU and UK), and Latin America.

•BHV-1530 FGFR3-directed ADC to be featured in oral presentation at ENA 2026; combination cohort with LIBTAYO® (cemiplimab-rwlc) now enrolling under clinical supply agreement with Regeneron.

NEW HAVEN, Conn., October 29, 2026/PRNewswire/ Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today provided a review of recent accomplishments and anticipated upcoming developments for the third quarter ended September 30, 2026.

Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "This quarter marked important progress in executing our strategy of building differentiated platforms and partnering them to create both near-term and long-term value. We are excited to have entered into the first ever regional collaboration for an extracellular protein degrader with Ono Pharmaceutical to develop and commercialize our MoDE IgG degrader portfolio, led by BHV-1300, in Japan, South Korea, Taiwan and the ASEAN region. The agreement provides up to $100 million in near-term payments, preserves our rights in the U.S., Europe and China, and further validates the potential of our MoDE and TRAP platforms. Additionally, our announced agreement with SK Biopharmaceuticals provides for $400 million in near-term, non-dilutive capital upon closing and positions opakalim for success with a leading epilepsy company as a partner. Establishing these unique collaborations with two leading global drug development and commercialization companies is a testament to the impressive potential and versatility of our portfolio.”

Dr. Coric continued, “Beyond these partnerships, we continue to advance a diverse and innovative pipeline. We are making meaningful progress with the first degraders from our MoDE and TRAP platforms, with BHV-1300 now in a pivotal Phase 3 trial in Graves’ disease and BHV-1400 expected to begin its next stage of clinical development in IgA nephropathy in the second half of 2026. A number of innovative new degraders are planned to follow in 2027. In epilepsy, RISE 3 topline data for our Kv7 activator opakalim remain on track for the second half of 2026, and we are working to complete an additional nonclinical safety package and look forward to closing our transaction with SK Biopharmaceuticals. We are also advancing taldefgrobep alfa for body recomposition, our TYK2/JAK1 inhibitor for Parkinson’s disease and intranasal oxytocin for tinnitus. In oncology, our clinical programs are led by FGFR3- and TROP2-directed antibody-drug conjugates. We believe the breadth of our pipeline positions Biohaven well heading into a pivotal period for the company.”

Third Quarter 2026 and Recent Business Highlights

Spinocerebellar Ataxia (SCA) Program

•The FDA has informed Biohaven that the company’s new drug application resubmission for Vyglxia (troriluzole) in SCA has been accepted for review. The resubmission included new positive supportive analyses.

•The FDA 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 2027. The FDA plans to convene a meeting of the Peripheral and C

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