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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

Mar 31, 2021

Astellas Establishes “Astellas Gene Therapies” as its Global Gene Therapy Center of Excellence

- Astellas integrates its wholly owned subsidiary, Audentes Therapeutics, and expands the mission to further Astellas’ position as a global leader in the field of Gene Therapy -

TOKYO, March 31, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that it will further integrate its wholly owned subsidiary, Audentes Therapeutics, and establish “Astellas Gene Therapies” within the organization...

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Mar 30, 2021

Astellas’ XOSPATA® (gilteritinib) Meets Overall Survival Endpoint in COMMODORE Trial of Patients with Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

- Confirmatory Phase 3 trial in China, other countries stopped early due to positive results at planned interim analysis -

TOKYO, March 30, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that a Phase 3 confirmatory trial of XOSPATA® (gilteritinib) in patients with relapsed (disease that has returned) or refractory (resistant to...

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Mar 29, 2021

Astellas Receives Positive CHMP Opinion for XTANDI^TM(enzalutamide) for Patients with Metastatic Hormone-Sensitive Prostate Cancer

If approved by the European Commission, enzalutamide will be the only oral therapy for the treatment of metastatic hormone-sensitive prostate cancer in addition to non-metastatic and metastatic castration-resistant prostate cancer

TOKYO, March 29, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion...

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Mar 26, 2021

Doshisha University, Wakayama Medical University and Astellas announce Respective Joint Researches to Maximize Drug Value using AI and Statistics

- Aiming to optimize decision-making in the drug development process and individual medications for patients -

TOKYO, March 26, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) has entered into two joint research agreements today to maximize the value of medications using AI and statistical methods. One agreement is with the...

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Mar 26, 2021

Astellas Garners New Indication & New Product Formulation Approvals From U.S. FDA for Children with Neurogenic Detrusor Overactivity (NDO)

Myrbetriq® (Mirabegron Extended-Release Tablets) Approved for Pediatric Patients with NDO Aged Three Years and Older Weighing 35 kg or More

TOKYO, March 26, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) approved Myrbetriq® (mirabegron extended-release tablets) for the treatment...

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Mar 26, 2021

European Medicines Agency Accepts Marketing Authorization Application for Enfortumab Vedotin

- Enfortumab vedotin to be reviewed under accelerated assessment for the treatment of locally advanced or metastatic urothelial cancer -

TOKYO and BOTHELL, Wash. – March 26, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced that a marketing authorization application (MAA) for enfortumab vedotin was...

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Mar 11, 2021

Astellas Submits New Drug Application for Enfortumab Vedotin in Japan

Enfortumab vedotin to be reviewed by Ministry of Health, Labour and Welfare for patients with locally advanced or metastatic urothelial cancer that has progressed after anti-cancer medication

TOKYO, March 11, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced the submission of a New Drug Application (NDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) for enfortumab vedotin...

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Feb 26, 2021

Notice Regarding Continuation of the Performance-linked Stock Compensation Scheme and Performance-linked Stock Delivery Scheme for the Domestic and Global Astellas Group Executives

TOKYO, February 26, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “the Company”) announced that at the meeting of the Board of Directors held today...

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Feb 19, 2021

Astellas Announces Positive Topline Results from Two Phase 3 Pivotal Global Trials of Fezolinetant for the Nonhormonal Treatment of Vasomotor Symptoms in Postmenopausal Women

TOKYO, February 19, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline results from the Phase 3 pivotal SKYLIGHT 1™ and SKYLIGHT 2™ clinical trials for fezolinetant, an investigational...

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Feb 18, 2021

Astellas and Seagen Announce Submission of Two Supplemental Biologics License Applications to the U.S. FDA for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer

- Submissions will be Reviewed Under Real-Time Oncology Review Based on Clinical Trials EV-301 and Cohort 2 of EV-201 -

TOKYO and BOTHELL, Wash. – Feb. 18, 2021 -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced completion of submissions for two supplemental Biologics License Applications...

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