2019.

• Dec.25.2019 R & D

  ONO and BMSKK Submit Supplemental Application for Approval of Opdivo and Yervoy Combination Therapy to Expand the Use for First-Line Treatment of Unresectable, Advanced or Recurrent Non-Small Cell Lung Cancer in Japan(188 KB)

• Dec.24.2019 R & D

  Karyopharm Submits New Drug Application to U.S. FDA for XPOVIO® (selinexor) as a Treatment for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma(150 KB)

• Dec.19.2019 R & D

  U.S. FDA Accepts and Grants Priority Review to sNDA for BRAFTOVI® (encorafenib) in Combination with ERBITUX® (cetuximab) (Braftovi Doublet) for the Treatment of BRAF^V600E-Mutant Metastatic Colorectal Cancer After Prior Therapy(149 KB)

• Dec.09.2019 R & D

  Two Clinical Results for Tirabrutinib (ONO-4059), a BTK Inhibitor, in Patients with “Primary Central Nervous System Lymphoma”, and “Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma” Presented at ASH 2019(150 KB)

• Dec.06.2019 Sustainability

  ONO receives "Platinum Kurumin" Certification as a Company Supporting Childcare(289 KB)

• Dec.03.2019 Sustainability

  ONO Receives 2019 Environment Minister's Award for Global Warming Prevention Activity in the "Implementation and Dissemination of Countermeasures" Category(104 KB)

• Nov.27.2019 R & D

  ONO Submits Supplemental Application for Additional Opdivo® Intravenous Infusion Monotherapy Dosage and Schedule in Japan(101 KB)

• Nov.27.2019 R & D

  ONO Submits an Application for Manufacturing and Marketing Approval in Japan for Tirabrutinib Hydrochloride (ONO-4059), a BTK Inhibitor, for the Treatment of Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma(123 KB)

• Nov.22.2019 R & D

  ONO Receives Supplemental Approval of KYPROLIS® for Intravenous Injection, a Proteasome Inhibitor, in Japan for Additional Dosage and Administration for a Kd Once-weekly Regimen in Relapsed or Refractory Multiple Myeloma(129 KB)

• Nov.21.2019 R & D

  Bristol-Myers Squibb Announces Update on CheckMate -915 for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Versus Opdivo Alone in Patients with Resected High-Risk Melanoma and PD-L1 <1%(116 KB)

• Nov.19.2019 Products

  Launch of Coralan® Tablet, an HCN Channel Blocker in Japan(239 KB)

• Nov.12.2019 R & D

  U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb's Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combination for Patients with Previously Treated Advanced Hepatocellular Carcinoma(120 KB)

• Nov.12.2019 R & D

  ONO and BMSKK Submit Supplemental Application for Approval of Additional Indication of Opdivo and Yervoy Combination Therapy in Japan for the Treatment of MSI-H Colorectal Cancer(186 KB)

• Oct.31.2019 Management / Finance

  Announcement on Financial Results for FY2019 2Q

• Oct.31.2019 Management / Finance

  Ono Announces Completion of Cancellation of Treasury Shares(98 KB)

• Oct.23.2019 R & D

  CheckMate -9LA, a Phase 3 Trial Evaluating Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) Combined with Chemotherapy, Meets Primary Endpoint Demonstrating Superior Overall Survival Compared to Chemotherapy Alone in First-Line Lung Cancer(40 KB)

• Oct.16.2019 Sustainability

  Support for Relief Efforts to the Disaster Caused by Typhoon 19 in 2019(41 KB)

• Oct.10.2019 Sustainability

  ONO Supports Recommendations of the Task Force on Climate-related Financial Disclosures (TCFD)(43 KB)

• Oct.01.2019 R & D

  Opdivo (Nivolumab) Demonstrates Statistically Significant Overall Survival Benefit versus Chemotherapy in Patients with Esophageal Cancer in Phase III ATTRACTION-3 Study Presented at ESMO 2019(52 KB)

• Sep.30.2019 R & D

  Five-Year Outcomes for Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Demonstrate Durable Long-Term Survival Benefits in Patients with Advanced Melanoma(36 KB)

• Sep.30.2019 R & D

  Adjuvant Treatment with Opdivo (nivolumab) Continues to Demonstrate Extended Recurrence-Free Survival at Three Years in Resected High-Risk Melanoma Patients(36 KB)

• Sep.30.2019 R & D

  Bristol-Myers Squibb Announces Final Results from CheckMate -227 Part 1 Demonstrating Superior Overall Survival for Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) vs. Chemotherapy in Advanced Non-Small Cell Lung Cancer(65 KB)

• Sep.20.2019 R & D

  ONO Receives a Manufacturing and Marketing Approval for Coralan® Tablet for the Treatment of Chronic Heart Failure in Japan(120 KB)

• Sep.17.2019 R & D

  Amgen Announces Phase 3 CANDOR Study Combining Kyprolis® (Carfilzomib) and Darzalex® (Daratumumab) Meets Primary Endpoint of Progression-Free Survival(36 KB)

• Sep.11.2019 R & D

  Bristol-Myers Squibb Announces Pooled Five-Year Survival Results for Opdivo (nivolumab) in Previously-Treated Advanced Non-Small Cell Lung Cancer Patients(36 KB)

• Sep.06.2019 R & D

  Bristol-Myers Squibb Provides Update on Phase 3 Opdivo (nivolumab) CheckMate -548 Trial in Patients with Newly Diagnosed MGMT-Methylated Glioblastoma Multiforme(36 KB)

• Sep.02.2019 Management / Finance

  Ono Announces Status and Completion of Acquisition of Own Shares(78 KB)

• Aug.28.2019 R & D

  ONO Submits an Application for Manufacturing and Marketing Approval for Tirabrutinib Hydrochloride (ONO-4059), a BTK inhibitor, for Treatment of Recurrent or Refractory Primary Central Nervous System Lymphoma in Japan(37 KB)

• Aug.08.2019 R & D

  ONO Submits an Application of ONOACT® for Intravenous Infusion 50mg・150mg, a Short-Acting Selective β1 Blocker for Additional Indication of Tachyarrhythmia Associated with Sepsis for a Partial Change in Approved Items of Manufacturing and Marketing Approval in Japan(119 KB)

• Aug.06.2019 Sustainability

  ONO's Greenhouse Gas Reduction Target Approved by “Science Based Targets (SBT) Initiative”(219 KB)

• Aug.01.2019 Management / Finance

  Ono Announces Status of Acquisition of Own Shares(34 KB)

• Aug.01.2019 Management / Finance

  Announcement on Financial Results for FY2019 1Q

• Jul.25.2019 R & D

  Bristol-Myers Squibb Provides Update on Part 2 of CheckMate -227(37 KB)

• Jul.25.2019 R & D

  Bristol-Myers Squibb Announces CheckMate -227 Part 1a Meets Co-Primary Endpoint of Overall Survival(51 KB)

• Jul.19.2019 Licensing

  Bayer, Bristol-Myers Squibb and Ono Pharmaceutical enter into a clinical collaboration agreement to investigate Stivarga® (regorafenib) and Opdivo® (nivolumab) as combination therapy in patients with colorectal cancer(62 KB)

• Jul.17.2019 Corporate

  Completion of Yamaguchi Plant, a New Manufacturing Plant(128 KB)

• Jul.11.2019 Sustainability

  ONO Selected for MSCI Japan ESG Select Leaders Index, an Index for Socially Responsible Investment(95 KB)

• Jul.11.2019 Licensing

  ONO and Forty Seven, Inc. Sign a License Agreement to Develop, Manufacture and Commercialize 5F9 in Japan, South Korea, Taiwan and Other Selected Countries in Southeast Asia(64 KB)

• Jul.08.2019 R & D

  Array BioPharma Announces Interim Analysis Results from the BEACON CRC Trial of BRAFTOVI + MEKTOVI + Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer at the ESMO 21st World Congress on Gastrointestinal Cancer(36 KB)

• Jul.05.2019 R & D

  Karyopharm Announces FDA Approval of XPOVIO^TM (selinexor) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma(35 KB)

• Jul.05.2019 Management / Finance

  Notice Concerning Determination of Details of Issuance of Stock Options (Stock Acquisition Rights)(33 KB)

• Jul.01.2019 Management / Finance

  Ono Announces Status of Acquisition of Own Shares(35 KB)

• Jun.25.2019 R & D

  Bristol-Myers Squibb Announces Results from CheckMate -459 Study Evaluating Opdivo (nivolumab) as a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma(36 KB)

• Jun.25.2019 Licensing

  ONO Enters into Exclusive License Agreement with Rafael Pharmaceuticals on CPI-613 (devimistat), a Cancer Metabolism Inhibitor, and Other Related Compounds(40 KB)

• Jun.20.2019 Management / Finance

  Notice Concerning Issuance of Stock Options (Stock Acquisition Rights)(118 KB)

• Jun.05.2019 Sustainability

  ONO Announces a Medium- and Long-term Environmental Vision for 2050 - Establishment of Environment Challenging ONO Vision (ECO VISION 2050) -(388 KB)

• Jun.05.2019 R & D

  Five-Year Survival Observed in Longest Follow-up to Date of Advanced Melanoma Patients Treated with the Combination of Opdivo (nivolumab) and Yervoy (ipilimumab)(36 KB)

• Jun.05.2019 R & D

  Bristol-Myers Squibb Announces First Presentation of Results for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combination in Advanced Hepatocellular Carcinoma at ASCO 2019(36 KB)

• Jun.03.2019 Management / Finance

  Ono Announces Status of Acquisition of Own Shares(34 KB)

• May.30.2019 R & D

  ONO Submits Supplemental Application of Opdivo® (Nivolumab) for Indication of Unresectable Advanced or Recurrent Esophageal Cancer in Japan for a Partial Change in Approved Items of Manufacturing and Marketing Approval(48 KB)

• May.30.2019 Management / Finance

  Announcement on Acquisition and Retirement of Own Shares(35 KB)

• May.22.2019 R & D

  Array BioPharma Announces BRAFTOVI + MEKTOVI + Cetuximab Meet Primary Endpoints of ORR and OS in Phase 3 BEACON CRC Trial Interim Analysis for the Treatment of BRAF^V600E-mutant Metastatic Colorectal Cancer(35 KB)

• May.22.2019 Corporate

  Ono's Statement in response to the Press Reports with respect to PD-1 Related Patents(36 KB)

• May.14.2019 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Received Additional Approvals related to Three Indications in Taiwan(102 KB)

• May.13.2019 R & D

  Bristol-Myers Squibb Announces Phase 3 CheckMate -498 Study Did Not Meet Primary Endpoint of Overall Survival with Opdivo (nivolumab) Plus Radiation in Patients with Newly Diagnosed MGMT-Unmethylated Glioblastoma Multiforme(36 KB)

• May.10.2019 R & D

  Certain Media Coverage relating to Opdivo Reported on May 9(47 KB)

• May.09.2019 Management / Finance

  Announcement on Financial Results for FY2018

• May.09.2019 Management / Finance

  Notice regarding Differences between Non-Consolidated Results for the Fiscal Year Ended March 31, 2019 and Those for the Previous Fiscal Year(100 KB)

• Apr.04.2019 Corporate

  Announcement on Candidates of Members of Board of Directors, Members of Audit & Supervisory Board and Corporate Officers(82 KB)

• Apr.03.2019 R & D

  Bristol-Myers Squibb Announces Long-Term Survival Results from Pooled Analyses of Opdivo (nivolumab) in Previously-Treated Non-Small Cell Lung Cancer Patients(53 KB)

• Mar.28.2019 R & D

  ONO Submits Supplemental Application of Opdivo® (Nivolumab) for Indication of MSI-H Unresectable Advanced or Recurrent Colorectal Cancer That Has Progressed Following Chemotherapy, for a Partial Change in Approved Items of Manufacturing and Marketing Approval in Japan(47 KB)

• Mar.27.2019 Licensing

  ONO Announces a Strategic Drug Discovery Alliance Agreement with Cancer Research UK and LifeArc for Cancer Immunotherapy(63 KB)

• Mar.27.2019 R & D

  A selective sodium-glucose co-transporter 2 (SGLT2) inhibitor Forxiga receives additional regulatory approval on indication and dosage and administration in type-1 diabetes in Japan(109 KB)

• Mar.26.2019 R & D

  A Short-Acting Selective β₁ Blocker, ONOACT® for Intravenous Infusion 50mg/150mg Approved for Additional Indication of Ventricular Arrhythmia in Japan(106 KB)

• Mar.19.2019 R & D

  ONO Submits Supplemental Application of Kyprolis® for Intravenous Injection, a Proteasome Inhibitor, for Additional Dosage and Administration for the Treatment of Relapsed or Refractory Multiple Myeloma in Japan(39 KB)

• Mar.18.2019 Licensing

  Ono Enters into Research Collaboration Agreement with twoXAR, Inc.(37 KB)

• Mar.14.2019 R & D

  ONO and Novartis Pharma Receive a Supplemental Approval for Formulation with New Ingredient of Rivastach® Patch and Exelon® Patch for the Treatment of Alzheimer's Disease Dementia(40 KB)

• Mar.11.2019 R & D

  BMSKK and ONO Submit Supplemental Applications of Orencia® for I.V. Infusion, Orencia® Syringe for S.C. Injection and Orencia® Autoinjector for S.C. Injection, a Selective T-cell Co-Stimulation Modulator, for Inhibition of Structural Damage of Joints in Rheumatoid Arthritis(54 KB)

• Feb.27.2019 R & D

  ONO Submits an Application for Manufacturing and Marketing Approval of Opicapone (ONO-2370) for the Treatment of Parkinson's Disease Patients with Motor Fluctuations in Japan(42 KB)

• Feb.26.2019 Products

  Launch of BRAFTOVI® Capsule 50 mg, a BRAF Inhibitor and MEKTOVI® Tablet 15 mg, a MEK Inhibitor in Japan(171 KB)

• Feb.26.2019 Products

  Launch of Demser® Capsule 250 mg, a Tyrosine Hydroxylase Inhibitor in Japan(82 KB)

• Feb.25.2019 Sustainability

  ONO Certified in 2019 as Outstanding Health and Productivity Management Organization (White 500)(135 KB)

• Feb.19.2019 R & D

  Ono and Seikagaku Announce the Topline Results from a Phase III Confirmatory Study of ONO-5704/SI-613 in Patients with Knee Osteoarthritis in Japan(94 KB)

• Feb.15.2019 R & D

  Opdivo (nivolumab) Plus Yervoy (ipilimumab) Shows Response in Pre-Treated Patients with Metastatic Castration-Resistant Prostate Cancer(47 KB)

• Feb.15.2019 R & D

  Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) Demonstrates Continued Survival Benefit at 30-Month Follow-up in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma(51 KB)

• Feb.01.2019 Management / Finance

  Announcement on Financial Results for FY2018 3Q

• Jan.31.2019 Licensing

  ONO Announces a Strategic Partnership Agreement with Repare Therapeutics for a Pol-theta Inhibitor Program(105 KB)

• Jan.22.2019 Sustainability

  ONO Selected by CDP as a Climate Change A List Company in 2018(75 KB)

• Jan.18.2019 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved for Expanded Use in Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy in Taiwan(70 KB)

• Jan.15.2019 R & D

  Array BioPharma Announces 15.3 Months Median Overall Survival from the Safety Lead-in of the Phase 3 BEACON CRC Trial of the Combination BRAFTOVI®, MEKTOVI® and ERBITUX® in BRAF-Mutant Metastatic Colorectal Cancer(35 KB)

• Jan.15.2019 R & D

  European Commission Approves Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) for First-Line Treatment of Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma(47 KB)

• Jan.10.2019 R & D

  Karyopharm Announces Submission of Marketing Authorization Application to the European Medicines Agency for Selinexor for the Treatment of Patients with Penta-Refractory Multiple Myeloma(35 KB)

• Jan.09.2019 R & D

  Opdivo® (Nivolumab) Demonstrates a Significant Extension in Overall Survival Versus Chemotherapy in Patients with Unresectable Advanced or Recurrent Esophageal Cancer in Phase III Clinical Study(41 KB)

• Jan.08.2019 R & D

  ONO Receives a Manufacturing and Marketing Approval for BRAFTOVI® Capsule, a BRAF Inhibitor and MEKTOVI® Tablet, a MEK Inhibitor for Indication of Unresectable BRAF-Mutant Melanoma in Japan(57 KB)

• Jan.08.2019 R & D

  ONO Receives Manufacturing and Marketing Approval in Japan for Demser® Capsule, a Tyrosine Hydroxylase Inhibitor, for Improvement of Status of Catecholamine Excess Secretion and its Accompanying Symptoms in Patients with Pheochromocytoma(60 KB)

• Jan.07.2019 Sustainability

  ONO Listed in FTSE4Good Index Series and FTSE Blossom Japan Index for Socially Responsible Investment(118 KB)