Biohaven Enters Strategic Licensing Agreement with Ono Pharma for Extracellular IgG Degraders in Japan and Select Asian Regions, Lead Candidate BHV-1300 in Phase 3 for Graves' Disease

Biohaven retains rights outside the licensed Asian markets and will receive approximately 20 percent royalties on Ono's territorial net sales.

Rhea-AI Summary

Biohaven (BHVN) entered an exclusive regional licensing agreement with Ono Pharmaceutical for its IgG degrader portfolio, with $80 million upfront. The license covers BHV-1300, BHV-1310 and BHV-1320 in Japan, South Korea, Taiwan and ASEAN countries. Terms provide $80 million at execution and a conditional $20 million milestone payment anticipated within a year after execution, bringing near-term payments to up to $100 million. Biohaven will receive royalties of approximately 20 percent on Ono's net sales in the territory and retains all rights elsewhere, including the United States, Europe and China.

BHV-1300, an investigational small molecule that removes IgG antibodies, is in Phase 3 development for Graves' disease. In a Phase 1b study in patients with Graves' disease, it reduced disease-causing antibodies to the TSH receptor, rapidly normalized free T3 and free T4 thyroid hormones, and improved patient symptoms.

9 points · 0 major

PositiveiHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

0 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate point$80 million upfront at agreement execution provides funding to Biohaven. 4.4% of market cap
• Moderate point. Forward-looking: it has not happened yet and may not happen.Approximately 20 percent royalties apply to Ono's net sales of licensed products in the territory.
• Moderate pointExclusive Ono license covers BHV-1300, BHV-1310 and BHV-1320 in Japan, South Korea, Taiwan and ASEAN countries.
• Moderate pointBHV-1300 is in Phase 3 development for Graves' disease.
• Minor pointAll rights outside the territory retained, including the United States, Europe and China.

4 minor points

• Minor pointPhase 1b Graves' disease results showed reduced TSH-receptor autoantibodies, rapid thyroid-hormone normalization and symptom improvement.
• Minor pointTotal IgG reductions of up to 87% occurred in ongoing Phase 1 studies.
• Minor pointPhase 1 safety and tolerability were characterized as favorable by Biohaven to date.
• Minor point. Forward-looking: it has not happened yet and may not happen.Additional autoimmune programs are being pursued for BHV-1300.

Negative

• Minor point. Forward-looking: it has not happened yet and may not happen.$20 million milestone payment depends on milestone achievement, anticipated within a year after agreement execution.

Key Figures

Near-term payments: Up to $100 million Upfront payment: $80 million Milestone payment: $20 million +1 more

Near-term payments

Up to $100 million

Licensing agreement consideration

Upfront payment

$80 million

Upon closing

Milestone payment

$20 million

Upon an anticipated milestone achievement within a year

Royalties

Approximately 20% of net sales

Licensed products sold by Ono in the territory

Previous Clinical trial Reports

1 past event · Latest: Jun 29

Same Type 1 event

1. Jun 29

   Phase 3 initiation

   24h Move

   -5.6%

   BHV-1300 began its pivotal Graves' disease trial after Phase 1b findings.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

igg, tsh receptor, subcutaneously, asgpr

4 terms

igg medical

"MoDE pan IgG degraders"

IgG is a common type of antibody — a protein the immune system makes to recognize and neutralize viruses, bacteria and other foreign substances. For investors, IgG matters because measuring these antibodies underlies many diagnostic tests, vaccine responses and antibody therapies; like a security badge that shows who has been exposed or is protected, IgG results can drive demand for medical products and influence clinical and commercial decisions.

tsh receptor medical

"autoantibody to the TSH receptor"

A TSH receptor (thyrotropin receptor, TSHR) is a cell-surface G protein–coupled receptor that binds thyroid-stimulating hormone (TSH) and triggers intracellular signaling—principally the cAMP pathway—to stimulate thyroid follicular cells to produce and release thyroid hormones and to grow. It is mainly located on thyroid gland cells but can also be found in certain other tissues (for example, orbital fibroblasts), and it is the target of stimulating or blocking autoantibodies that underlie autoimmune thyroid disorders.

subcutaneously medical

"subcutaneously administered BHV-1300"

Given or delivered beneath the skin into the fatty layer just under the surface, usually by injection or a small device. For investors, whether a medicine is given subcutaneously affects how easy it is for patients to use, how often doses are needed, and the cost and complexity of manufacturing and regulation—think of it like placing a slow-release patch under a carpet instead of pouring medicine on top of it, which changes convenience and ongoing demand.

asgpr medical

"asialoglycoprotein receptor (ASGPR)"

Asialoglycoprotein receptor (ASGPR) is a cell-surface receptor found primarily on liver hepatocytes that recognizes and binds glycoproteins whose terminal sialic acid residues have been removed, exposing galactose or N‑acetylgalactosamine. Once it binds such ligands the receptor mediates rapid uptake into the liver cell by endocytosis and delivery to intracellular degradation pathways, a property exploited to concentrate certain drugs or nucleic-acid therapies in the liver. Its activity is largely limited to hepatocytes and depends on the presence of specific sugar structures on the ligand, so it does not mediate uptake in most other tissues.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

• Ono will obtain an exclusive license to develop and commercialize Biohaven's MoDE pan IgG degraders in Japan, South Korea, Taiwan, and ASEAN member states, led by BHV-1300 and including certain next-generation follow-on IgG degraders. Biohaven will receive up to $100 million in near-term payments, including $80 million upfront and eligible to receive another $20 million upon a milestone achievement anticipated within a year, and royalties of approximately twenty percent on net sales by Ono in the licensed territory. Biohaven retains all rights outside of the licensed territory, including in the US, Europe, and China.
• BHV-1300, the lead MoDE degrader, is an investigational small-molecule extracellular IgG degrader in Phase 3 development for Graves' disease, the lead indication. In a Phase 1b study in patients with Graves' disease, 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 and patient-friendly autoinjector self-administration.
• This is the first regional collaboration for an extracellular protein degrader, pairing Biohaven's clinically validated MoDE platform, predicated on groundbreaking chemistry originating at Yale University, with Ono's proven development and commercial capabilities across Japan, South Korea, Taiwan, and Southeast Asia.

NEW HAVEN, Conn. and OSAKA, Japan, Oct. 8, 2026 /PRNewswire/ -- Biohaven Ltd. together with its wholly owned subsidiaries, ("Biohaven") (NYSE: BHVN) today announced that it has entered into a strategic licensing and collaboration agreement with Ono Pharmaceutical Co., Ltd. ("Ono") (TYO: 4528), under which Ono will obtain an exclusive license to develop and commercialize Biohaven'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 (ASEAN). The agreement is our first regional collaboration for an extracellular protein degrader from Biohaven's platform, a technology that originated in research at Yale University and has been advanced into the clinic by Biohaven. BHV-1300 is an investigational small-molecule IgG degrader currently in Phase 3 development for Graves' disease, with potential to treat a broad spectrum of IgG-mediated autoimmune diseases.

Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "Ono will be the ideal partner to bring this innovative immune-modulating technology to patients across Japan and key Asian markets. This is the first regional collaboration for an extracellular protein degrader, and it validates a platform that began with pioneering chemistry from the Spiegel Lab at Yale University and now spans a broad and diverse portfolio of MoDE and TRAP degraders. Few companies in the world can match Ono's innovation in drug development or its demonstrated ability to translate breakthrough science into transformative therapies, as it did in helping to define modern cancer immunotherapy. We are excited for an outstanding collaboration to accelerate new therapeutics to patients."

Under the terms of the agreement, Ono will obtain an exclusive license to develop and commercialize BHV-1300, BHV-1310, and BHV-1320 in Japan, South Korea, Taiwan, and the ASEAN region. Biohaven will receive up to $100 million in near-term payments, including $80 million upon closing and another $20 million upon a milestone achievement anticipated within a year, and royalties of approximately twenty percent on net sales in the licensed territory. Biohaven retains all rights to the MoDE IgG degrader portfolio outside of the licensed territory, including in the US, Europe, and China.

Toichi Takino, Ph.D., President and COO of Ono, commented, " Biohaven has a strong track record of developing innovative therapeutics leveraging its proprietary drug discovery platforms. Through this collaboration, we aim to strengthen our late-stage pipeline in the immunology and inflammation field, one of Ono's key focus areas. We look forward to working with Biohaven to advance the development program with the goal of providing a new therapeutic to patients with Graves' disease in Japan, South Korea, Taiwan and ASEAN countries and to maximize the value of this treatment. "

Tova Gardin, M.D., Chief Translational Officer of Biohaven, commented, "Pairing BHV-1300 with Ono's regional development and commercial excellence gives this portfolio its strongest and fastest path to patients in two of the world's most important pharmaceutical markets, while securing meaningful non-dilutive capital and retaining substantial long-term upside for our shareholders."

Summary of the Terms

• Upfront and Milestone Payments to Biohaven:
  • $80 million at execution of the agreement
  • $20 million milestone payment to Biohaven upon a milestone achievement anticipated within a year after execution of the agreement
• Royalties to Biohaven: Approximately 20 percent on net sales of the licensed products by Ono in the territory
• Territory: Japan, South Korea, Taiwan, and the ASEAN region
• Rights Retained by Biohaven: All rights to the MoDE IgG degrader portfolio outside Japan, South Korea, Taiwan, and the ASEAN region, including in the United States, Europe, and China

All figures are expressed in US dollars.

Advisors

J.P. Morgan Securities LLC is serving as exclusive financial advisor and Sullivan & Cromwell LLP is serving as legal advisor to Biohaven.

About the MoDE IgG Degrader Portfolio: BHV-1300, BHV-1310, and BHV-1320

BHV-1300 is an investigational small molecule and potential first-in-class extracellular IgG degrader, rationally designed to leverage the body's natural hepatic clearance mechanisms to selectively target and remove IgG1, IgG2, and IgG4, a principal driver of many immune-mediated diseases. BHV-1300 spares IgG3 to preserve patient immune protection against bacteria, viruses, and parasites. In ongoing Phase 1 studies, subcutaneously administered BHV-1300 produced rapid, deep, and sustained reductions in total IgG of up to 87%, with a favorable safety and tolerability profile observed to date, and demonstrated tunable dosing suitable for both acute and chronic disease management. BHV-1300 is designed for convenient self-administration via a patient-friendly autoinjector and is currently being evaluated in a pivotal Phase 3 trial in Graves' disease, with additional programs being pursued in other autoimmune conditions.

BHV-1310 and BHV-1320 are next-generation IgG MoDE degraders engineered to enable therapeutic targeting and broader development across IgG-mediated diseases, extending the breadth and durability of Biohaven's MoDE IgG degrader portfolio.

About the MoDE and TRAP Degrader Platforms

Originating from research in the laboratory of Dr. David Spiegel at Yale University, Biohaven's MoDE platform is the first clinically validated technology enabling the targeted degradation of disease-causing proteins in the extracellular space. Each MoDE is a bispecific small molecule that binds a pathogenic target and directs it to the liver through the asialoglycoprotein receptor (ASGPR) for rapid and deep degradation via the body's own endosomal and lysosomal pathways. This approach offers a differentiated profile relative to FcRn-targeting antibodies, including rapid onset of action, deep and tunable lowering, patient-friendly subcutaneous self-administration, and the potential to be combined with standard-of-care biologic therapies. Biohaven's next-generation TRAP (Targeted Removal of Aberrant Protein) degraders extend the platform with highly selective molecules, each engineered to remove a single specific disease-causing protein. Together, the MoDE and TRAP platforms form the foundation of a broad, diverse, and rapidly expanding pipeline of precision immunology therapeutics with the potential to address a wide range of immune-mediated and other diseases.

About Biohaven

Biohaven Ltd. (NYSE: BHVN) is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments across immunology, neuroscience, and oncology. Biohaven is advancing an innovative portfolio of therapeutics built on proven drug development experience and multiple proprietary platforms, including Kv7 ion channel modulation for epilepsy; MoDE and TRAP extracellular protein degradation for immunological diseases; next generation ADC platform for oncology; and myostatin inhibition for neuromuscular and metabolic diseases, including obesity. For more information, visit www.biohaven.com.

About Ono Pharmaceutical Co., Ltd.

Ono Pharmaceutical Co., Ltd. delivers innovative medicines for patients worldwide. Upholding its philosophy of "Dedicated to the Fight against Disease and Pain," Ono targets areas with unmet medical needs including oncology, immunology & inflammation, and neurology, and fosters partnerships with academic and biotech organizations to accelerate drug discovery. Through its affiliate, Deciphera Pharmaceuticals, Ono is accelerating clinical development and commercial operations in the US and Europe to drive global business expansion and further its commitment to patient care. For more information, please visit the company's website at https://www.ono-pharma.com/en.

Forward-Looking Statements

This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "continue", "plan", "will", "believe", "may", "expect", "potential first-in-class", "potentially", "groundbreaking" and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements, including statements regarding the receipt of upfront, milestone, and royalty payments; the strategic benefits of the collaboration; and the future development, timing and potential marketing approval and commercialization of development candidates, including BHV-1300, BHV-1310, and BHV-1320, are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, including the studies of BHV-1300, BHV-1310, and BHV-1320; the ability of the parties realize the anticipated benefits of the transaction; the timing of planned interactions and filings with the FDA and other regulatory authorities; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations". The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

MoDE and TRAP are trademarks of Biohaven Therapeutics Ltd.

Biohaven Investor Contact:

Jennifer Porcelli
Vice President, Investor Relations
jennifer.porcelli@biohavenpharma.com
+1 (201) 248-0741

Biohaven Media Contact:

Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
+1 (312) 961-2502

View original content to download multimedia:https://www.prnewswire.com/news-releases/biohaven-enters-strategic-licensing-agreement-with-ono-pharma-for-extracellular-igg-degraders-in-japan-and-select-asian-regions-lead-candidate-bhv-1300-in-phase-3-for-graves-disease-302901852.html

SOURCE Biohaven Ltd.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What are the payment terms of Biohaven's licensing agreement with Ono?

Biohaven will receive up to $100 million in near-term payments: $80 million at agreement execution and a conditional $20 million milestone payment anticipated within a year after execution. Royalties are approximately 20 percent of Ono's net sales of licensed products in the territory.

Which drugs and territories does Biohaven's Ono licensing agreement cover?

Ono will obtain an exclusive license to develop and commercialize BHV-1300, BHV-1310 and BHV-1320 in Japan, South Korea, Taiwan and ASEAN countries. Biohaven retains all rights to the MoDE IgG degrader portfolio outside that territory, including the United States, Europe and China.

What did Biohaven report from ongoing Phase 1 studies of BHV-1300?

Subcutaneously administered BHV-1300 produced rapid, deep and sustained reductions in total IgG of up to 87% in ongoing Phase 1 studies. Biohaven characterized the safety and tolerability profile observed to date as favorable and reported tunable dosing suitable for acute and chronic disease management.