Biohaven signs Ono license deal for $80M at closing
The agreement permits Ono to terminate for convenience in whole or by product or country, upon specified prior written notice.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Form Type
8-K
Rhea-AI Filing Summary
Biohaven Ltd. (BHVN) entered into an exclusive regional license and collaboration with Ono Pharmaceutical Co., Ltd. for its MoDE pan-IgG degrader portfolio, led by BHV-1300 and including BHV-1310 and BHV-1320, in Japan, South Korea, Taiwan and ASEAN countries. Ono will pay $80 million upon closing and a further $20 million after receipt of specified stability test results if Ono elects to continue development and commercialization; the milestone was anticipated within a year after execution. Ono will also pay royalties of approximately 20% on licensed-product net sales, subject to specified reductions and adjustments.
Ono is generally responsible, at its own expense, for development, regulatory activities and commercialization in the licensed territory. Biohaven will continue specified studies, while Ono funds specified territory activities and shares specified costs of global clinical studies. Biohaven retains rights outside the territory, including the United States, Europe and China. BHV-1300 is in Phase 3 development for Graves' disease; Biohaven reported that a Phase 1b study showed reductions in the pathogenic TSH-receptor autoantibody, rapid normalization of free T3 and free T4, and symptom improvement.
1 point · 0 major0 major · 0 points
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.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate point. Forward-looking: it has not happened yet and may not happen.$80 million upfront payment to Biohaven upon closing. 4.8% of market cap
Negative
- None.
Filing Explained
The agreement allows Ono to terminate the license for convenience, in whole or by product or country, on specified prior notice. If terminated, Ono’s license rights end, subject in specified circumstances to limited sales of existing inventory; Biohaven also has transition and rights-reversion rights.
8-K Event Classification
3 items: 1.01, 7.01, 9.01
3 items
Item 1.01
Entry into a Material Definitive Agreement
Business
The company signed a significant contract such as a merger agreement, credit facility, or major partnership.
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
Upfront payment: $80 million
Milestone payment: $20 million
Royalties on net sales: Approximately 20%
+2 more
5 metrics
Upfront payment
$80 million
Ono payment to Biohaven upon closing
Milestone payment
$20 million
After specified stability test results and subject to Ono electing to continue development and commercialization; anticipated within a year after execution
Royalties on net sales
Approximately 20%
Licensed products sold by Ono in the licensed territory, subject to specified reductions and adjustments
Maximum total IgG reduction
Up to 87%
Biohaven-reported results from ongoing Phase 1 studies of BHV-1300
Development stage
Phase 3
BHV-1300 development for Graves' disease
Key Terms
royalty-bearing license, milestone achievement, MoDE platform, ASGPR, +1 more
5 terms
royalty-bearing license financial
"exclusive, royalty-bearing license"
A royalty-bearing license is a legal agreement that lets one party use another’s intellectual property—such as a patent, trademark, or copyrighted technology—in exchange for ongoing payments tied to sales, production, or a fixed fee per unit. For investors it signals a predictable cost and revenue sharing: licensors gain a steady income stream with lower operating risk, while licensees may face reduced margins but avoid large upfront development costs, like renting a recipe and paying per cake sold.
milestone achievement financial
"upon a milestone achievement"
MoDE platform technical
"Biohaven's MoDE platform is the first clinically validated technology"
ASGPR technical
"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.
endosomal and lysosomal pathways technical
"via the body's own endosomal and lysosomal pathways"
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How much will Biohaven receive from the Ono deal?
Ono will pay Biohaven $80 million upon closing and a further $20 million upon a milestone achievement after receipt of specified stability test results and subject to Ono electing to continue development and commercialization. The milestone was anticipated within a year after execution. Royalties are approximately 20% on net sales, subject to specified reductions and adjustments.
Can Ono terminate its BHVN licensing agreement?
Ono may terminate the agreement for convenience in whole or on a product-by-product or country-by-country basis, upon specified prior written notice. Both parties also have termination rights for uncured material breach and specified bankruptcy or insolvency events; Biohaven has additional rights for certain cessations of development and specified patent challenges.
What results has Biohaven reported for BHVN's BHV-1300?
Biohaven reported that ongoing Phase 1 studies showed reductions in total IgG of up to 87%, with a favorable safety and tolerability profile observed to date. In a Phase 1b study in patients with Graves' disease, Biohaven reported reduced pathogenic TSH-receptor autoantibody and improvement in patient symptoms.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 8, 2026
(Exact name of registrant as specified in its charter)
| Not applicable | ||||||||
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
(Address of principal executive offices, including zip code)
(203 ) 404-0410
(Registrant’s telephone number, including area code)
Not applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading symbol | Name of each exchange on which registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 1.01. Entry into a Material Definitive Agreement.
Collaboration and License Agreement
On October 8, 2026, Biohaven Ltd., together with its wholly owned subsidiaries (the “Company”), entered into a Collaboration and License Agreement (the “License Agreement”) with Ono Pharmaceutical Co., Ltd. (“Ono”). Pursuant to the License Agreement, the Company granted Ono an exclusive, royalty-bearing license, with the right to grant sublicenses subject to the terms of the License Agreement, 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 (the “Licensed Territory”), subject to the terms of the License Agreement. The Company retains all rights to the licensed portfolio outside the Licensed Territory, including in the United States, Europe and China.
Under the License Agreement, Ono will pay the Company a one-time, non-creditable and non-refundable upfront payment of $80 million upon closing and another $20 million upon a milestone achievement, following Ono’s receipt of specified stability test results and subject to Ono’s election to continue development and commercialization of the licensed compounds and products in the Licensed Territory. If Ono elects not to continue the program after receipt of specified stability test results in accordance with the License Agreement, the License Agreement will terminate and the milestone achievement payment will not become payable.
In addition, Ono will pay the Company royalties of approximately 20% on net sales of licensed products in the Licensed Territory, subject to specified reductions and adjustments.
Ono is generally responsible, at its own expense, for development, regulatory activities and commercialization of the licensed compounds and products in the Licensed Territory and is required to use commercially reasonable efforts to conduct these activities. The Company will continue to conduct specified ongoing studies and development activities, with Ono funding specified activities conducted in the Licensed Territory and sharing specified costs of global clinical studies.
The License Agreement contains specified restrictions on each party’s activities involving competing IgG degraders and provides Ono with a right of first negotiation with respect to certain follow-on compounds in the Licensed Territory.
Unless earlier terminated, the License Agreement will continue until the expiration of all applicable royalty terms. Ono may terminate the License Agreement, in whole or on a product-by-product or country-by-country basis, for convenience upon specified prior written notice. The parties also have specified termination rights, including for uncured material breach and specified bankruptcy or insolvency events. The Company has additional termination rights for certain cessations of development and specified patent challenges. Upon termination, the applicable license rights granted to Ono will terminate, subject in specified circumstances to limited rights to sell existing inventory. The License Agreement also provides for specified transition and reversion rights in favor of the Company relating to regulatory filings, clinical trials and intellectual property.
The foregoing description of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the License Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.
2
Item 7.01. Regulation FD Disclosure.
On October 8, 2026, the Company issued a press release announcing the transaction contemplated by the License Agreement. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and incorporated in this Item 7.01 by reference.
The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Exhibit Description | |||||||
| 10.1*† | Collaboration and License Agreement, dated as of October 8, 2026, by and between Biohaven Pharmaceuticals, Inc. and Ono Pharmaceutical Co., Ltd. | |||||||
| 99.1 | Press Release, dated October 8, 2026, “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.” | |||||||
| 104 | The cover page of this Current Report on Form 8-K, formatted in Inline XBRL. | |||||||
* Certain schedules and similar attachments have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company agrees to furnish supplementally a copy of any omitted schedule or attachment to the Securities and Exchange Commission upon request.
† Certain identified information has been excluded from this exhibit because it is both (i) not material and (ii) the type of information that the Company customarily and actually treats as private or confidential.
3
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: October 15, 2026
| Biohaven Ltd. | |||||
| By: | /s/ Matthew Buten | ||||
| Matthew Buten | |||||
| Chief Financial Officer | |||||
4
Exhibit 99.1
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
October 8, 2026
•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
