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Astellas is committed to providing timely and accurate information about our business, science and products. This section offers global resources for investors, journalists and media professionals. News and resources from our local affiliates can be viewed in the Local news section. If you are not an investor or journalist, click here.

Month Year

Dec 3, 2019

Astellas Presents New Data on XOSPATA® (gilteritinib) in FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia at the 2019 American Society of Hematology Annual Meeting

Emerging mutations in patients with treatment resistance, from Phase 3 ADMIRAL study, will be focus of oral presentation

TOKYO, Dec. 3, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the presentation of new data in acute myeloid leukemia (AML) at...

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Dec 2, 2019

Astellas Announces Status of Acquisition of Own Shares

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Nov 26, 2019

Astellas Announces the Approval of XTANDI® (enzalutamide) by the China National Medical Products Administration (NMPA) Approval based on Asian PREVAIL study of men with metastatic castration-resistant prostate cancer

TOKYO, November 26, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that the China National Medical Products Administration...

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Nov 21, 2019

Astellas and Welldoc Enter into Strategic Alliance for Digital Therapeutics - Develop and commercialize digital health solutions globally for multiple therapeutic areas, including in Japan for diabetes patients -

TOKYO and Columbia, Maryland, November 20, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) and Welldoc, Inc. (President, CEO: Kevin McRaith,...

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Nov 20, 2019

Launch of Evrenzo® (roxadustat) Tablets in Japan for the Treatment of Renal Anemia in Patients on Dialysis - First-in-Class Orally Administered HIF-PH Inhibitor -

TOKYO, November 20, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced launch of Evrenzo® Tablet 20mg, 50mg and 100mg (generic...

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Oct 31, 2019

Astellas Announces Acquisition of Own Shares and Cancellation of Treasury Stock

(Acquisition of own shares pursuant to the provision of its Articles of Incorporation in accordance with Article 459, paragraph 1 of the Companies Act and cancellation of treasury stock pursuant to the provisions of Article 178 of the Companies Act)

Tokyo, October 31, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D.) today announced that at the meeting of the Board of Directors held today, a resolution was...

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Oct 31, 2019

PANDION AND ASTELLAS ANNOUNCE COLLABORATION TO DELIVER PANCREAS-TARGETED IMMUNOMODULATORS

Exclusive Collaboration Utilizes Pandion’s Platform to Discover Novel Tissue-Specific Immunomodulators for Type 1 Diabetes and Other Autoimmune Diseases of the Pancreas

Cambridge, MA, and Tokyo, October 31, 2019 - Pandion Therapeutics, Inc. (“Pandion”), and Astellas Pharma Inc. (TSE: 4503, "Astellas") announced today the signing of a License and Collaboration...

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Oct 31, 2019

New England Journal of Medicine Publishes Results from Astellas’ Phase 3 ADMIRAL Trial of XOSPATA® (gilteritinib) in Adult Patients with FLT3 Mutation-Positive Relapsed/Refractory Acute Myeloid Leukemia1

- Results were published online and in the October 31 print edition of the Journal -

TOKYO, October 31, 2019 - The New England Journal of Medicine published detailed results from the Phase 3 ADMIRAL trial, which found that Astellas Pharma Inc.’s (TSE: 4503, President and CEO:...

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Oct 28, 2019

U.S. FDA Grants Fast Track Designation to Astellas for the Development of ASP1128 for Patients at Risk for Acute Kidney Injury

TOKYO, October 28, 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) has granted...

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Oct 25, 2019

European Commission Approves Astellas’ XOSPATA™ (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

Approval follows accelerated assessment, orphan designation by European Medicines Agency

TOKYO, Oct. 25, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the European Commission (EC) has approved the oral...

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Oct 24, 2019

Astellas Announces Personnel Changes

Astellas Announces Personnel Changes

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Oct 18, 2019

Annual Report 2019 is now available.

To enable deeper stakeholder understanding of Astellas' efforts to continue to create value for sustainable growth, we have published the annual report as an integrated report. In order to provide...

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Oct 15, 2019

Astellas Transfers Three Products in Asia Region to Daiichi Sankyo

TOKYO, October 15, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that subsidiaries of Astellas will transfer their marketing...

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Oct 2, 2019

Astellas Commits Nearly $13 Million to Fund Boston-area Start-Up Innovation in Cell and Gene Therapy - Financial support for LabCentral Incubators builds on Astellas’ $1 Billion+ investment in Boston’s Life Science Community -

TOKYO, October 1 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced it will invest nearly $13 million into two innovation incubators...

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Sep 30, 2019

Seattle Genetics and Astellas Announce Results from Phase 1 Trial of Investigational Agent Enfortumab Vedotin in Combination with Immune Therapy Pembrolizumab as First-Line Treatment for Advanced Bladder Cancer

- Study Met Outcomes for Safety and 71 Percent of Patients with Locally Advanced or Metastatic Urothelial (Bladder) Cancer Had a Confirmed Response -

TOKYO and BOTHELL, Wash., September 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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Sep 24, 2019

Astellas Receives Positive CHMP Opinion for XOSPATA® (gilteritinib) as a Monotherapy for Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

If approved by the European Commission, gilteritinib would represent one of the few advances in Europe for AML over the past 40 years1

TOKYO, Sept. 20, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the Committee for Medicinal Products for Human Use (CHMP)...

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Sep 20, 2019

Evrenzo® (roxadustat) Tablets Approved in Japan for the Treatment of Anemia Associated with Chronic Kidney Disease in Dialysis Patients

TOKYO and San Francisco, September 20, 2019- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and FibroGen, Inc. (Nasdaq: FGEN, Interim CEO: James A...

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Sep 17, 2019

Seattle Genetics and Astellas Announce US FDA Grants Priority Review for Enfortumab Vedotin Biologics License Application in Locally Advanced or Metastatic Urothelial Cancer

- Food & Drug Administration Sets Prescription Drug User Fee Action Date for March 15, 2020 -

BOTHELL, Wash. and TOKYO, September 16, 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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Sep 13, 2019

Astellas and iota Biosciences Enter into Collaborative Research and Development Agreement -Companies to explore new biosensing and treatment measures using ultra-small implantable medical devices-

TOKYO and Berkeley, CA., September 13, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) and Iota Biosciences, Inc. (Co-founders and Co-CEOs:...

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Sep 2, 2019

RIKEN and Astellas Enter into Worldwide Exclusive Licensing Agreement for Artificial Adjuvant Vector Cell Technology in Oncology

Saitama and Tokyo, September 2, 2019 - RIKEN (President: Hiroshi Matsumoto, Ph.D.) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today...

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Aug 22, 2019

U.S. FDA Grants XTANDI® (enzalutamide) Application Priority Review for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer

XTANDI Supplemental New Drug Application (sNDA) Seeks to Add an Indication for Men with Prostate Cancer that Has Spread but Is Sensitive to Hormone Therapy

TOKYO and NEW YORK, August 21, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and...

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Aug 9, 2019

Yokohama City University, Tokyo University of the Arts and Astellas Launched Health Mock Lab. to Create New Digital Healthcare Solutions Using Gamification

TOKYO, August 9, 2019 - Yokohama City University (Kanagawa, Chairperson of the Board of Trustees and CEO: Yoshiyuki Futami, “YCU”) , Tokyo University of the Arts (Tokyo, President: Kazuki...

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Aug 6, 2019

Astellas Initiates Phase 3 Clinical Trials for Fezolinetant in Postmenopausal Women with Vasomotor Symptoms

TOKYO, August 6, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced dosing of the first patient in the SKYLIGHT 1™ Phase 3 pivotal...

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Jul 30, 2019

Astellas Submits Supplemental New Drug Application for Approval of Additional Indication of XTANDI® for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer in Japan

TOKYO, July 30, 2019 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that it has submitted a supplemental new drug application for the...

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Jul 24, 2019

Astellas Announces Acceptance by the European Medicines Agency of a Variation Application for Regulatory Review for Use of XTANDITM (enzalutamide) in metastatic Hormone-Sensitive Prostate Cancer

TOKYO AND CHERTSEY, July 24 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced the acceptance by the European Medicines Agency (EMA) of a Type...

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