Corporate Events

Ono Pharmaceutical Co., Ltd. announced that it resolved to establish Ono Global Reinsurance Inc. as a wholly-owned subsidiary at the meeting of its Board of Directors held on August 1, 2025. The purpose of this establishment is to improve risk management systems; ONO will create Ono Global Reinsurance Inc., a subsidiary that underwrites non-life insurance for ONO and its group companies as reinsurance, with the aim of establishing and operating stable insurance programs. The outline of Ono Global Reinsurance Inc. is as follows: the name of the company will be Ono Global Reinsurance Inc., and it will be located in the State of Hawaii, USA. The representative will be Masaki Itoh, who will serve as the Managing Director. The establishment is planned for December 2025, with a capital of JPY 10 billion also planned. The business focus will be on reinsurance underwriting for ONO and its group companies, and it will be a wholly-owned subsidiary of ONO.

Deciphera Pharmaceuticals, LLC andOno Pharmaceutical Co., Ltd. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of vimseltinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability. The positive CHMP opinion is a scientific recommendation for marketing authorization and one of the final steps before the European Commission (EC), which has the authority to approve medicines in the European Union (EU), issues a decision on Deciphera's marketing authorization application (MAA) for vimseltinib. This decision is expected in the second quarter of the fiscal year ending March 31, 2026. The positive CHMP opinion are supported by compelling efficacy and safety results from the pivotal Phase 3 MOTION study of vimseltinib in patients with TGCT not amenable to surgery with no prior anti-CSF1/CSF1R therapy (prior therapy with imatinib or nilotinib allowed), compared to placebo, as well as the Phase 1/2 study of vimseltinib. ROMVIMZA™? (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatic tenOSynovial giant cell tumor ("TGCT") for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

Ono Pharmaceutical Co., Ltd., Q1 2026 Earnings Call, Aug 01, 2025

Vertex Pharmaceuticals Incorporated and Ono Pharmaceutical Co., Ltd. announced an exclusive collaboration and license agreement for the development and commercialization of Vertex's povetacicept in Japan and South Korea. Povetacicept is a recombant fusion protein therapeutic and dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines with best-in-class potential being studied for the treatment of immunoglobulin A nephropathy (IgAN), primary membranous nephropathy (pMN) and other B cell-mediated diseases. Under the terms of the agreement, Vertex will receive an upfront payment, as well as certain regulatory and commercial milestone payments and tiered royalties. Ono will utilize its extensive development expertise to help advance Vertex's clinical trials for povetacicept and will be responsible for obtaining marketing authorizations in Japan and South Korea. The agreement includes povetacicept for both IgAN and pMN, with the potential to add other indications. 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.

Ono Pharmaceutical Co., Ltd. announced that they will report Q1, 2026 results at 12:00 PM, Tokyo Standard Time on Aug 01, 2025

Ono Pharmaceutical Co., Ltd. announced that the results from the open label Phase 2 PROSPECT Study of tirabrutinib is to be presented at the 2025 American Society for Clinical Oncology (ASCO) annual meeting. Patients in the U.S. with relapsed or refractory primary central nervous system lymphoma (R/R PCNSL) who received oral tirabrutinib as a monotherapy achieved an overall response rate (ORR) of 67% Tirabrutinib is a highly selective irreversible, second generation Bruton's tyrosine kinase inhibitor discovered by Ono in Japan. In March 2023, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to investigational tirabrutinib for the treatment of PCNSL. Study Results: In the PROSPECT Study, 48 patients with R/R PCNSL received oral tirabrut inib as a monotherapy once daily. The primary endpoint was ORR, and secondary endpoints included duration of response (DOR), time to response (TTR), and safety. After a median follow-up of 11.5 months, ORR was 67%, with a complete response rate of 44%. Median DOR was 9.3 months, and median TTR was 1.0 months. Exploratory endpoints included median overall survival, which was not reached, and median progression-free survival, which was 6.0 months. Tirabrut inib demonstrated a generally favorable safety profile. At data cutoff, 13 patients (27%) remained on tirabrutinib treatment. The main reasons for discontinuation were disease progression (54.2%) and death (8.3); one patient discontinued due to an adverse event (AE). Incidence of grade 3 treatment-emergent adverse events (TEAEs) was 56.3%. Any-grade treatment-related TEAEs were experienced by 75.0%, and most frequently included anemia (18.8%), rash maculo-papular (16.7%), fatigue (14.6%), neutrophil count decreased (14.6%), lymphocyte count decreased (14.6), pruritus (14.6%), and rash (14.6%). Two patients died of TEAEs, which were considered unrelated to study treatment.

R&D Day / ASCO PROSPECT Data Presentation.

Ono Pharmaceutical Co., Ltd. provided consolidated earnings guidance for the fiscal year ending March 31, 2026. For the year, the company expects revenue of JPY 490,000 million, operating profit of JPY 85,000 million, profit for the year of JPY 67,000 million and basic earnings per share of JPY 142.62.

Ono Pharmaceutical Co., Ltd. announced dividend for the fiscal year ended March 31, 2025 of JPY 40.00 per share compared to JPY 40.00 per share a year ago. Scheduled date of dividend payment commencement is June 20, 2025. For the second quarter of fiscal year ending March 31, 2026, the company expects dividend of JPY 40.00 per share compared to JPY 40.00 per share a year ago. For the full year of fiscal year ending March 31, 2026, the company expects dividend of JPY 40.00 per share compared to JPY 40.00 per share a year ago.

R&D Day

Ono Pharmaceutical Co., Ltd., Annual General Meeting, Jun 19, 2025.

Ono Pharmaceutical Co., Ltd. expected to report Q1 2026 results on July 31, 2025. This event was calculated by S&P Global (Created on May 8, 2025).

Ono Pharmaceutical Co., Ltd., 2025 Earnings Call, May 08, 2025

Ono Pharmaceutical Co., Ltd. announced that they will report fiscal year 2025 results on May 08, 2025

Sustainability Meeting

Ono Pharmaceutical Co., Ltd. expected to report Fiscal Year 2025 results on May 9, 2025. This event was calculated by S&P Global (Created on February 2, 2025).

Ono Pharmaceutical Co., Ltd., Q3 2025 Earnings Call, Feb 03, 2025

Ono Pharmaceutical Co., Ltd. Presents at BIO Partnering @JPM Week, Jan-13-2025 . Venue: San Francisco Marriott Marquis, San Francisco, California, United States.

Ono Pharmaceutical Co., Ltd. announced that it has entered into a drug discovery collaboration agreement with Congruence Therapeutics to generate novel small molecule correctors against multiple protein targets in the oncology area by leveraging Congruence's proprietary drug discovery platform, Revenir. Under the terms of the agreement, Congruence will generate small molecule correctors by leveraging Congruence's proprietary drug discovery engine called, Revenir™. Ono will obtain an exclusive option right to develop, manufacture and commercialize the identified small molecule correctors worldwide. Congruence will be eligible to receive an upfront payment, research expenses, milestone payments based on research and development progress and sales, as well as tiered royalties based on net sales. Revenir™, Congruence's proprietary computational drug discovery platform, captures the dynamic biophysical changes caused by mutations in proteins, offering unique insights into protein defects and their correction. By examining surface features and a spectrum of biophysical descriptors across an ensemble of protein conformers, Revenir™ predicts small molecule induced correction of the underlying defect.

Congruence Therapeutics announced that it has entered into a research collaboration agreement with Ono Pharmaceutical Co. Ltd. (Ono) to discover novel drug candidates leveraging Congruence's proprietary drug discovery platform, Revenir™?. Congruence will apply its technology and expertise toward multiple cancer protein targets. Once the discovery effort advances to a prespecified stage, Ono has the option to acquire exclusive worldwide rights to further develop and commercialize small molecule correctors generated during the collaboration. The collaboration will leverage Congruence's purpose-built computational drug discovery engine called Revenir™?, which captures the biophysical changes caused by mutations in proteins. By examining surface features and numerous biophysical descriptors of both the mutated and wild-type proteins, Congruence can derive novel insights regarding protein defects and how to correct them. Congruence's current pipeline consists of both first-in-class and best-in-class potential therapeutic candidates that address significant unmet medical need in a number of high value indications. Under the terms of the collaboration, Congruence will receive an undisclosed upfront payment and is eligible to receive milestone payments upon the achievement of certain discovery, development, approval and sales events - as well as tiered royalties based on annual net sales of related products. Ono will additionally reimburse Congruence for the research costs it incurs in connection with the collaboration. Ono has the option to take an exclusive worldwide license to development candidates discovered under the collaboration.

Ono Pharmaceutical Co., Ltd. announced that they will report Q3, 2025 results on Feb 03, 2025

Ono Pharmaceutical Co., Ltd., ¥ 40.0, Cash Dividend, Mar-28-2025

Ono Pharmaceutical Co., Ltd. expected to report Q3 2025 results on January 30, 2025. This event was calculated by S&P Global (Created on October 31, 2024).

Ono Pharmaceutical Co., Ltd., Q2 2025 Earnings Call, Nov 01, 2024

Ono Pharmaceutical Co., Ltd. announced that they will report Q2, 2025 results on Oct 31, 2024