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Month Year

Jul 17, 2019

Astellas and Seattle Genetics Announce Submission of Biologics License Application to FDA for Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer

-Submission Based on Pivotal Phase 2 Trial Results Recently Presented at Annual Meeting of American Society of Clinical Oncology-

TOKYO and BOTHELL, Wash., July 16, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seattle Genetics, Inc. (Nasdaq:SGEN) today announced...

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Jul 17, 2019

Astellas and Frequency Therapeutics Enter into License Agreement for FX-322, a Regenerative Treatment Candidate for Hearing Loss

Astellas Obtains the Exclusive Rights to Develop and Commercialize FX-322 in Ex-US Markets; Frequency Retains U.S. Rights

TOKYO and WOBURN, Mass., July 17, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) and Frequency Therapeutics, Inc. (CEO: David Lucchino,...

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Jul 10, 2019

Launch of Smyraf® Tablets - Provides a new therapeutic option for rheumatoid arthritis in patients who have an inadequate response to conventional therapies -

TOKYO, July 10, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced the launch of the Smyraf® 50 mg and 100 mg Tablets (generic...

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Jun 26, 2019

Astellas Named to FTSE4Good Index Series for the Eighth Consecutive Year

Tokyo, June 26, 2019 - Astellas Pharma Inc. (President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that it has been named to the FTSE4Good Index Series for the eighth...

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Jun 18, 2019

HYPERCHOLESTEROLEMIA DRUG REPATHA® SC INJECTION RECEIVES SUPPLEMENTAL INDICATION APPROVAL AS MONOTHERAPY FOR TREATING HYPERCHOLESTEROLEMIA PATIENTS NOT SUITABLE FOR STATIN THERAPY

TOKYO (June 18, 2019) –, Amgen Astellas BioPharma K.K. (Headquarters, Tokyo; President and Representative Director: Steve Sugino, “Amgen Astellas”) and Astellas Pharma Inc. (Headquarters,...

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Jun 17, 2019

Launch of Gonax® 240 mg (New dosage form) in Japan for the treatment of prostate Cancer

TOKYO, June 17, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that it launched Gonax® 240 mg (generic name: degarelix acetate, “

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Jun 7, 2019

Bisono® Tape 2 mg, a Transdermal Patch of β1 Blocker, Launched in Japan

Tokyo: June 7, 2019 - TOA EIYO Ltd. (President: Atsuo Takahashi, Ph.D., “TOA EIYO”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced...

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Jun 4, 2019

Astellas and Seattle Genetics Announce Antibody-Drug Conjugate Enfortumab Vedotin Produced Tumor Response Rate of 44 Percent in Patients with Most Common Type of Advanced Urothelial (Bladder) Cancer

-First Investigational Therapy in a Pivotal Trial to Address Unmet Need for Patients with Advanced Urothelial Cancer After Treatment with Platinum Chemotherapy and a PD-1 or PD-L1 Inhibitor-

TOKYO and BOTHELL, Wash., June 3, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that...

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May 30, 2019

U.S. FDA Approves Supplemental New Drug Application Adding Overall Survival Data for XOSPATA® (gilteritinib)

- Phase 3 ADMIRAL trial showed patients treated with XOSPATA demonstrated longer Overall Survival than those who received salvage chemotherapy1 -

TOKYO – May 30, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) approved a...

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May 10, 2019

Partial Amendments to the Articles of Incorporation

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May 10, 2019

Revision of Remuneration System for Directors

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May 10, 2019

Notice Regarding the Performance-linked Stock Compensation Scheme

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Apr 25, 2019

Astellas Announces Cancellation of Treasury Shares

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Apr 25, 2019

Changes of Representative Director and Directors

Changes of Representative Director and Directors

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Apr 1, 2019

Phase 3 ADMIRAL Trial Data Show XOSPATA® (gilteritinib) Significantly Prolongs Overall Survival in Adult Patients with FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia -Study results will be presented at AACR2019-

TOKYO – April 1, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) today announced results from the Phase 3 ADMIRAL clinical trial comparing...

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Mar 28, 2019

Seattle Genetics and Astellas Announce Positive Topline Results from Pivotal Trial of Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer - Companies Plan to Submit Biologics License Application Later This Year –

BOTHELL, Wash. and TOKYO, Mar 28, 2019 – Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced...

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Mar 26, 2019

Oral JAK Inhibitor Smyraf® Tablets Approved in Japan for the Treatment of Rheumatoid Arthritis (including prevention of structural joint damage) in Patients Who Have an Inadequate Response to Conventional Therapies

TOKYO, March 26, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that Smyraf® 50 mg and 100 mg Tablets (generic name:...

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Mar 26, 2019

Astellas Presents Fezolinetant Phase 2b Clinical Trial Results at Endocrine Society’s Annual Meeting (ENDO) - Investigational compound fezolinetant reduced frequency and severity of vasomotor symptoms in postmenopausal women -

TOKYO, March 26, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced results from a Phase 2b dose-finding study of fezolinetant,...

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Mar 22, 2019

Notice of Completion of Acquisition of Own Shares

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Mar 4, 2019

EVENITY® SUBCUTANEOUS INJECTION 105 mg SYRINGE LAUNCHED IN JAPAN FOR THE TREATMENT OF OSTEOPOROSIS WITH HIGH RISK OF FRACTURE

TOKYO (March 4, 2019) - Amgen Astellas BioPharma K.K. (Headquarters, Tokyo; President and Representative Director: Steve Sugino, “Amgen Astellas”), Astellas Pharma Inc. (Headquarters, Tokyo;...

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Mar 1, 2019

Astellas Announces Status of Acquisition of Own Shares

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Feb 28, 2019

Astellas Announces Acceptance of XOSPATATM (gilteritinib) for Regulatory Review by the European Medicines Agency

TOKYO, February 28, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the submission for a marketing authorisation...

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Feb 11, 2019

Phase 3 ARCHES Trial Shows XTANDI® (enzalutamide) Significantly Improved Radiographic Progression-Free Survival in Men with Metastatic Hormone-Sensitive Prostate Cancer

Data to be presented at the 2019 Genitourinary Cancers Symposium

NEW YORK and TOKYO, Feb. 11, 2019 – Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today results from the Phase...

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Feb 5, 2019

Astellas Announces Personnel Changes

Astellas Announces Personnel Changes

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Jan 31, 2019

Astellas Announces Acquisition of Own Shares

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Jan 22, 2019

Astellas and KM Biologics Expiration of Distribution Agreement for Human Vaccines, etc. and Blood Plasma Products

Tokyo and Kumamoto, January 22, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) and KM Biologics Co., Ltd. (President and Representative...

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Jan 17, 2019

Transfer of Sale and Distribution, and Termination of Co-promotion for Symbicort® Turbuhaler®

TOKYO and OSAKA January 17, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) and AstraZeneca K.K. (Representative Director and President: Stefan...

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Jan 9, 2019

EVENITY® SUBCUTANEOUS INJECTION 105mg SYRINGE RECEIVES THE-FIRST-IN-THE-WORLD APPROVAL IN JAPAN FOR THE TREATMENT OF OSTEOPOROSIS AT HIGH RISK OF FRACTURE

EVENITY® (romosozumab) Approved to Reduce the Risk of Fractures and Increase Bone Mineral Density in Postmenopausal Women and Men With Osteoporosis

TOKYO (January 9, 2019) - Amgen Astellas BioPharma K.K. (Headquarters, Tokyo; President and Representative Director: Steve Sugino, “Amgen Astellas”), Astellas Pharma Inc. (Headquarters, Tokyo;...

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Jan 8, 2019

Astellas Announces Approval in Japan for the treatment of prostate cancer, Gonax® for partial changes (addition of dosage and administration) and addition of Gonax® 240 mg

TOKYO, January 8, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that gonadotrophin-releasing hormone (GnRH) receptor antagonist,...

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Jan 8, 2019

Additional Approvals for Bisono® Tape, a Transdermal Patch containing a β1 Blocker, for Atrial Fibrillation, for a 2 mg strength and for improved formulations of 4 mg and 8 mg strengths in Japan

Tokyo: January 8, 2019 - Toa Eiyo Ltd. (President: Atsuo Takahashi, Ph.D., “Toa Eiyo”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D.) announced today that Toa...

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Dec 21, 2018

Approval of Suglat® Tablets, Selective SGLT2 Inhibitor, for Additional Indication of type 1 diabetes mellitus and Additional dosage and administration in Japan

Tokyo, December 21, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) and Kotobuki Pharmaceutical Co., Ltd. (President and CEO; Hiroshi Tomiyama,...

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Dec 20, 2018

Astellas and Pfizer Announce Positive Top-Line Results from Phase 3 ARCHES Trial of XTANDI® (enzalutamide) in Men with Metastatic Hormone-Sensitive Prostate Cancer

TOKYO and NEW YORK, Dec. 20, 2018 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced that the Phase 3 ARCHES...

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Dec 14, 2018

Astellas Acquires Potenza Therapeutics - Acquisition adds clinical stage novel immuno-oncology programs to Astellas’ oncology pipeline -

TOKYO, December 14, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that it exercised, and closed on its exclusive option to...

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Dec 11, 2018

Astellas Launches XOSPATA® (gilteritinib) in the U.S. for the Treatment of Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation

TOKYO – December 11, 2018 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) today announced that XOSPATA® (generic name: gilteritinib) is now...

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Dec 3, 2018

Launch of XOSPATA® Tablets 40 mg in Japan - Provides a new therapeutic option for patients with AML -

TOKYO, December 3, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced the launch of the FLT3 (FMS-like tyrosine kinase 3) inhibitor...

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Dec 3, 2018

Astellas Presents Updated Results from Phase 1 Study of Gilteritinib Plus Chemotherapy in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)

TOKYO – December 3, 2018 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) today announced updated results from a Phase 1 study of gilteritinib in...

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Nov 29, 2018

XOSPATA® (gilteritinib) Approved by U.S. FDA for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) with a FLT3 Mutation

- FLT3 mutation-positive AML is a life-threatening disease with significant unmet medical needs -

TOKYO – November 29, 2018 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) approved...

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Nov 28, 2018

Cimzia® (certolizumab pegol) 200mg AutoClicks® for S.C. Injection Newly Launched

UCB Japan (headquarters: Shinjuku-ku, Tokyo; president: Kanako Kikuchi; hereafter referred to as “UCB Japan”; when referring to the global UCB group, “UCB”) and Astellas Pharma Inc....

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Nov 27, 2018

BLINCYTO® for drip infusion 35 μg launched in Japan for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia

Amgen Astellas BioPharma K.K. (Headquarters, Tokyo; President and Representative Director: Steve Sugino, “Amgen Astellas”) and Astellas Pharma Inc. (Headquarters, Tokyo; President and CEO:...

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Nov 22, 2018

Astellas Executes License Agreement with an Option to Acquire JVS-100 Gene Therapy Program from Juventas

TOKYO and CLEVELAND, Ohio, November 22, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Juventas Therapeutics (President & CEO: Rahul Aras,...

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Nov 20, 2018

Astellas Global Health Foundation Launches - Foundation to Support Improving Access to Health for Underserved Populations -

TOKYO and NORTHBROOK, Ill., November 20, 2018 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced the launch of the Astellas Global Health...

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Nov 19, 2018

Astellas to Present New Data on Gilteritinib in Multiple Populations of FLT3 Mutation-Positive Acute Myeloid Leukemia (AML) Patients at the 2018 American Society of Hematology (ASH) Annual Meeting

- Abstracts include updated results from Phase 1 study of gilteritinib in patients with newly diagnosed AML -

TOKYO – November 19, 2018 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) today announced it will present new data in Acute Myeloid Leukemia (AML)...

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Nov 5, 2018

Science Based Targets Initiative Approves Astellas’ Greenhouse Gas Reduction Plan

TOKYO, November 5, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that the company’s mid-to-long term greenhouse gas (GHG)...

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Oct 31, 2018

Astellas Announces Construction of New Research, Development and Manufacturing Facilities for Drugs Using Innovative Modalities/Technologies Including Antibodies and Cell Therapies

TOKYO, October 31, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that construction and renovation of new facilities for the...

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Oct 30, 2018

ASN Kidney Week 2018: Data Presented from Two Japanese Phase 3 Studies on Roxadustat in the Treatment of Anemia Associated with Chronic Kidney Disease in Patients on Dialysis

TOKYO and San Francisco, October 30, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and FibroGen, Inc. (Nasdaq: FGEN, CEO: Thomas B. Neff,...

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Oct 29, 2018

Astellas Receives European Approval for XTANDI™ (enzalutamide) for Adult Men with High-Risk Non-Metastatic Castration-Resistant Prostate Cancer

Results from the PROSPER trial show a median metastasis-free survival (MFS) of 36.6 months for enzalutamide plus androgen deprivation therapy (ADT) vs. 14.7 months for men who received placebo plus ADT

TOKYO, October 29, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the European Commission (EC) has approved a new indication...

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Oct 23, 2018

Astellas and BANDAI NAMCO Entertainment to Jointly Develop Smartphone Exercise Support App

TOKYO , October 23, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and BANDAI NAMCO Entertainment Inc. (President and CEO: Satoshi Oshita,...

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Oct 9, 2018

Astellas, Mitsubishi Tanabe Pharma, and Daiichi Sankyo Announce Second Public Recruitment Offering of "JOINUS®", a Joint Research Program to Discover New Drugs using Drug-Repositioning Compound Library

TOKYO and OSAKA, October 9, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”), Mitsubishi Tanabe Pharma Corporation (TSE: 4508, President and CEO:...

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Oct 5, 2018

CYTOKINETICS AND ASTELLAS PROVIDE UPDATES REGARDING COLLABORATIVE SKELETAL MUSCLE PROGRAM

SOUTH SAN FRANCISCO, Calif., and TOKYO, Oct. 5, 2018 – Cytokinetics, Incorporated (Nasdaq: CYTK, “Cytokinetics”) and Astellas Pharma Inc. (TSE: 4503, “Astellas”) today provided an update...

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Oct 1, 2018

Astellas Submits New Drug Application in Japan of Roxadustat for The Treatment of Anemia Associated with Chronic Kidney Disease in Patients on Dialysis

TOKYO and San Francisco, October 1, 2018 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and FibroGen, Inc. (Nasdaq: FGEN, CEO: Thomas B. Neff,...

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