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News

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

Feb 22, 2023

Astellas Announces Update on Preliminary Safety and Efficacy Data from FORTIS Study of Investigational AT845 in Adults with Late-Onset Pompe Disease

Data presented at the 19th Annual WORLDSymposium^TM 2023

TOKYO, February 22, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced an update on preliminary safety and efficacy data from its ongoing FORTIS Phase1/2 clinical trial evaluating the safety...

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Feb 20, 2023

Astellas Provides Update on Fezolinetant New Drug Application in U.S.

TOKYO, February 20, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the U.S. Food and Drug Administration (FDA) notified the company that it is extending the original priority...

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Feb 13, 2023

Astellas Supports Victims of the Earthquake in Turkey and Syria

TOKYO, February 13, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) would like to express its deepest sympathy to victims of the earthquake in Turkey and Syria...

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Feb 9, 2023

Astellas Commits to Achieve Net Zero Greenhouse Gas Emissions by 2050

TOKYO, February 9, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced its commitment to achieve net zero greenhouse gas (GHG) emissions by 2050...

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Feb 6, 2023

Astellas Announces Change of President and CEO and Management Structure

TOKYO, February 6, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that at a meeting of its Board of Directors, held today, approved changes of its Representative...

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Feb 6, 2023

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, February 6, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that at the meeting of the Board of Directors held today, a resolution was adopted to acquire its own shares pursuant...

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Jan 24, 2023

Astellas Transfers MYCAMINE^® Product Worldwide

TOKYO, January 24, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that Astellas and Sandoz AG (“Sandoz”) have entered into an Asset Purchase Agreement, under which Astellas will transfer the...

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Jan 20, 2023

Astellas Announces Hold Lifted by FDA on FORTIS Clinical Trial of AT845 Investigational Treatment for Adult Patients with Late-Onset Pompe Disease

TOKYO, January 20, 2023 – 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 lifted the clinical hold on January 19th for the FORTIS Ph1/2 clinical trial evaluating the safety...

Read more about Astellas Announces Hold Lifted by FDA on FORTIS Clinical Trial of AT845 Investigational Treatment for Adult Patients with Late-Onset Pompe Disease
Jan 19, 2023

Astellas Receives SBTi Approval for Revised Science-Based Climate Goals to Reduce Greenhouse Gas Emissions

TOKYO, January 19, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that the Science Based Targets initiative (SBTi)*1 has validated and approved its greenhouse gas...

Read more about Astellas Receives SBTi Approval for Revised Science-Based Climate Goals to Reduce Greenhouse Gas Emissions
Jan 19, 2023

Astellas to Present Positive Findings from Phase 3 SPOTLIGHT Trial of Zolbetuximab during 2023 ASCO GI Cancers Symposium

Data shows investigational zolbetuximab reduced risk of progression or death by 24.9%

TOKYO, Jan. 19, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today will present detailed results from the Phase 3 SPOTLIGHT trial evaluating first-line treatment with zolbetuximab, an investigational first-in-class Claudin...

Read more about Astellas to Present Positive Findings from Phase 3 SPOTLIGHT Trial of Zolbetuximab during 2023 ASCO GI Cancers Symposium
Jan 9, 2023

Selecta Biosciences and Astellas Announce Exclusive Licensing and Development Agreement for Xork IgG Protease

Next-generation IgG protease candidate Xork to be licensed for development with AT845, an investigational Astellas Gene Therapies’ product, for the treatment of Pompe Disease

WATERTOWN, Mass. and TOKYO, Japan, January 9, 2023 – Selecta Biosciences, Inc. (NASDAQ: SELB, President and CEO: Carsten Brunn, Ph.D., “Selecta”), and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” or “Astellas Gene Therapies”) today announced...

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Jan 4, 2023

Astellas Confirms Unfavorable Federal Circuit Decision in LEXISCAN^® 0.4 mg/mL U.S. Patent Trial

TOKYO, January 4, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) confirmed the Court of Appeals for the Federal Circuit (CAFC) affirmed the earlier decision by the U.S. District Court for the District of Delaware that all asserted...

Read more about Astellas Confirms Unfavorable Federal Circuit Decision in LEXISCAN^® 0.4 mg/mL U.S. Patent Trial
Dec 22, 2022

Astellas, Eisai, Daiichi Sankyo and Takeda Agree to Collaborate to Reduce Environmental Burden in the Field of Pharmaceutical Packaging

TOKYO and Osaka, December 22, 2022 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, “Astellas”), Eisai Co., Ltd. (TSE: 4523, CEO: Haruo Naito, “Eisai”), Daiichi Sankyo Company, Limited (TSE: 4568, President : Sunao Manabe, "Daiichi Sankyo") and Takeda...

Read more about Astellas, Eisai, Daiichi Sankyo and Takeda Agree to Collaborate to Reduce Environmental Burden in the Field of Pharmaceutical Packaging
Dec 20, 2022

Astellas, Seagen and Merck Announce FDA Acceptance of sBLA for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

– This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting –

TOKYO, BOTHELL, Wash. and RAHWAY, N.J. – December 20, 2022 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”), Seagen Inc. (Nasdaq: SGEN) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today...

Read more about Astellas, Seagen and Merck Announce FDA Acceptance of sBLA for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer
Dec 16, 2022

Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 GLOW Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-negative Locally Advanced Unresectable or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers

Astellas’ GLOW trial, the second Phase 3 trial in CLDN18.2 positive, HER2-negative locally advanced unresectable or metastatic gastric and GEJ cancers, meets primary endpoint for progression-free survival (PFS) and key secondary endpoint for overall survival (OS)

TOKYO, December 16, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline results from the Phase 3 GLOW clinical trial evaluating the efficacy and safety of zolbetuximab in...

Read more about Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 GLOW Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-negative Locally Advanced Unresectable or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers
Nov 29, 2022

Notice of Issuance of Unsecured Corporate Bonds

TOKYO, November 29, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today successfully priced its inaugural offering of dual-tranche JPY unsecured...

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Nov 17, 2022

Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 SPOTLIGHT Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-Negative Locally Advanced or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers

Astellas’ SPOTLIGHT trial meets primary endpoint of progression-free survival (PFS) Full data to be presented at future scientific congress

TOKYO, November 17, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline results from the Phase 3 SPOTLIGHT clinical trial evaluating the efficacy and safety of zolbetuximab in...

Read more about Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 SPOTLIGHT Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-Negative Locally Advanced or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers
Oct 24, 2022

Astellas and Taysha Gene Therapies Announce Strategic Investment to Support Development of Taysha’s AAV-based Gene Therapy Programs

- Taysha Gene Therapies is an emerging leader in the development of AAV gene therapies; new collaboration aimed at enhancing development of two of Taysha’s novel product candidates for rare monogenic central nervous system diseases with serious unmet medical needs -

TOKYO and DALLAS, TEXAS, October 24, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Taysha Gene Therapies, Inc. (NASDAQ: TSHA, CEO: RA Session II, “Taysha”) today announced a strategic investment to support...

Read more about Astellas and Taysha Gene Therapies Announce Strategic Investment to Support Development of Taysha’s AAV-based Gene Therapy Programs
Oct 12, 2022

Astellas to Present Findings from Phase 3 Long-Term Safety Study of Fezolinetant in Oral Session at The North American Menopause Society 2022 Annual Meeting

SKYLIGHT 4™ study results demonstrate the 52-week safety and tolerability of fezolinetant 30 mg and 45 mg once daily

TOKYO, October 12, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) will present 52-week results from the Phase 3 SKYLIGHT 4™ clinical study evaluating the safety and tolerability of fezolinetant, an investigational oral...

Read more about Astellas to Present Findings from Phase 3 Long-Term Safety Study of Fezolinetant in Oral Session at The North American Menopause Society 2022 Annual Meeting
Oct 4, 2022

Astellas and Pantherna Enter into a New Technology Evaluation Agreement for Research with Expanded Target Organ to Generate mRNA-Based Regenerative Medicine Programs Using Direct Reprogramming

TOKYO and Hennigsdorf, Germany, October 4, 2022 - Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pantherna Therapeutics GmbH (CEO:Klaus Giese, Ph.D., “Pantherna”) today announced that the companies...

Read more about Astellas and Pantherna Enter into a New Technology Evaluation Agreement for Research with Expanded Target Organ to Generate mRNA-Based Regenerative Medicine Programs Using Direct Reprogramming
Sep 30, 2022

European Medicines Agency Accepts Astellas’ Marketing Authorization Application for Fezolinetant

If authorized by the European Commission, fezolinetant would be a nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause

TOKYO, September 30, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the European Medicines Agency (EMA) has accepted for regulatory review the company’s marketing authorization application...

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Sep 26, 2022

Astellas Confirms District Court Decision for an Interim Injunction Against Hospira for LEXISCAN® 0.4mg/mL

TOKYO, September 26, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) confirms the U.S. District Court for the District of Delaware’s order granting an interim injunction enjoining Hospira from launching its generic version of...

Read more about Astellas Confirms District Court Decision for an Interim Injunction Against Hospira for LEXISCAN® 0.4mg/mL
Sep 12, 2022

Astellas, Seagen and Merck Announce Results of Clinical Trial Investigating PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) and PADCEV as Monotherapy in First-Line Advanced Urothelial Cancer

– Results demonstrated a 64.5% confirmed objective response rate in patients treated with investigational combination of enfortumab vedotin and pembrolizumab –

TOKYO, BOTHELL, Wash. and RAHWAY, N.J. -- September 12, 2022 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”), Seagen Inc. (Nasdaq:SGEN) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today...

Read more about Astellas, Seagen and Merck Announce Results of Clinical Trial Investigating PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) and PADCEV as Monotherapy in First-Line Advanced Urothelial Cancer
Sep 5, 2022

Astellas Announces Topline Results from Phase 3 Long-Term Safety Study of Fezolinetant in Mainland China

Clinical trial evaluated the safety and tolerability of 30 mg dose for the treatment of vasomotor symptoms (VMS) associated with menopause

TOKYO, September 5, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced topline results from the Phase 3 MOONLIGHT 3™ clinical trial in women in mainland China evaluating the long-term safety...

Read more about Astellas Announces Topline Results from Phase 3 Long-Term Safety Study of Fezolinetant in Mainland China
Aug 18, 2022

U.S. FDA Accepts Astellas’ New Drug Application for Fezolinetant

If approved by the FDA, fezolinetant would be a nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause

TOKYO, August 18, 2022 – 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 accepted the company’s New Drug Application (NDA) for fezolinetant, an investigational oral...

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Aug 2, 2022

Astellas Announces Management Structure

TOKYO, August 2, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the following changes to its management structure effective...

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Jul 26, 2022

Astellas and Seagen Announce Positive Topline Results For PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as First-Line Treatment for Advanced Urothelial Cancer

– Companies plan to discuss results with regulatory authorities –

TOKYO and BOTHELL, Wash.--July 26, 2022—Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced positive topline results from the phase 1b/2 EV-103 clinical trial...

Read more about Astellas and Seagen Announce Positive Topline Results For PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as First-Line Treatment for Advanced Urothelial Cancer
Jul 22, 2022

Astellas Unveils Plans to Open New Biotech Campus in South San Francisco

New 154,000 square-foot facility will provide a West Coast center with a focus on research, innovation, and commercial collaboration across corporate and program areas

TOKYO and SAN FRANCISCO - July 22, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced plans to create an integrated biotechnology campus in South San Francisco as its West Coast innovation and research...

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Jul 5, 2022

Mogrify and Astellas announce collaboration to conduct research on in vivo regenerative medicine approaches to address sensorineural hearing loss

Cambridge, UK, and Tokyo, Japan, 05 July 2022: Mogrify Limited (CEO: Darrin M. Disley, Ph.D., “Mogrify®”), a biopharmaceutical company transforming the lives of patients through a novel class of in vivo reprogramming therapies, and Astellas Pharma Inc...

Read more about Mogrify and Astellas announce collaboration to conduct research on in vivo regenerative medicine approaches to address sensorineural hearing loss
Jun 30, 2022

Sales Pilot of Disposable Holter ECG Device "EG Holter™" Begins

TOKYO, OSAKA, and IWATE, June 30, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ), Nitto Denko Corporation (TSE: 6988, President: Hideo Takasaki, “Nitto”), and M. Heart Co., Ltd. (President and CEO: Yoshimi...

Read more about Sales Pilot of Disposable Holter ECG Device "EG Holter™" Begins
Jun 28, 2022

Astellas and Sutro Biopharma Announce Worldwide Strategic Collaboration to Advance Novel Immunostimulatory Antibody-Drug Conjugates (iADCs)

- iADCs are a next-generation modality for treating cancer and designed to boost anti-cancer activity, offering potential new options for patients who do not respond to existing cancer immunotherapies -

TOKYO and SOUTH SAN FRANCISCO, Calif., June 28, 2022 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Sutro Biopharma, Inc. (NASDAQ: STRO, CEO: William J. Newell, JD, “Sutro”) today announced a worldwide, strategic...

Read more about Astellas and Sutro Biopharma Announce Worldwide Strategic Collaboration to Advance Novel Immunostimulatory Antibody-Drug Conjugates (iADCs)
Jun 27, 2022

Astellas Announces FDA Update on the FORTIS Clinical Trial of AT845 in Adults with Late-Onset Pompe Disease

TOKYO, June 27, 2022 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced that the US Food and Drug Administration (FDA) has placed a clinical hold...

Read more about Astellas Announces FDA Update on the FORTIS Clinical Trial of AT845 in Adults with Late-Onset Pompe Disease
Jun 24, 2022

Astellas Submits Fezolinetant New Drug Application to U.S. FDA

Application targets treatment of moderate to severe vasomotor symptoms associated (VMS) with menopause

TOKYO, June 24, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced a New Drug Application (NDA) for fezolinetant has been submitted to the U.S. Food and Drug Administration...

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Jun 1, 2022

Astellas and GO Therapeutics Enter into Strategic Research and License Agreement to Develop Novel Antibodies for Immuno-Oncology

- Collaboration to Accelerate Next-Generation Cancer Treatment -

TOKYO and Cambridge, Mass., June 1, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and GO Therapeutics, Inc. (Co-Founder and CEO: Constantine Theodoropulos, “GO”) today announced that Xyphos Biosciences...

Read more about Astellas and GO Therapeutics Enter into Strategic Research and License Agreement to Develop Novel Antibodies for Immuno-Oncology
May 20, 2022

Astellas Confirms Unfavorable District Court Decision in LEXISCAN® 0.4mg/mL U.S. Patent Trial

TOKYO, May 20, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today confirmed the U.S. District Court for the District of Delaware ruling that all asserted claims of the 8,106,183; 8, 524,883; and RE47301 patents for LEXISCAN®...

Read more about Astellas Confirms Unfavorable District Court Decision in LEXISCAN® 0.4mg/mL U.S. Patent Trial
May 19, 2022

Astellas Analysis Shows No Evidence of Increased Risk of Cardiovascular Events or Mortality with Roxadustat Compared with Erythropoiesis-Stimulating Agents (ESAs) at 59th ERA Congress 2022

Pooled Phase 3 data for anemia of CKD patients, incident dialysis or not receiving dialysis from the ALPINE Phase 3 clinical trial program

TOKYO, May 19, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced results from a pooled analysis of patients with symptomatic anemia associated with chronic kidney disease (CKD) who are non-dialysis...

Read more about Astellas Analysis Shows No Evidence of Increased Risk of Cardiovascular Events or Mortality with Roxadustat Compared with Erythropoiesis-Stimulating Agents (ESAs) at 59th ERA Congress 2022
May 16, 2022

Astellas to Present New Research Further Supporting Roxadustat Safety in the Treatment of Symptomatic Anemia of Chronic Kidney Disease at 59th ERA Congress 2022

Three abstracts provide additional insights into roxadustat safety profile and effect on iron parameters

TOKYO, May 16, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced the presentation of new roxadustat data at the 59th European Renal Association (ERA) Congress, taking place May 19–22, 2022...

Read more about Astellas to Present New Research Further Supporting Roxadustat Safety in the Treatment of Symptomatic Anemia of Chronic Kidney Disease at 59th ERA Congress 2022
May 12, 2022

Notice Regarding Continuation of the Performance-linked Stock Compensation Scheme

TOKYO, May 12, 2022– Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “the Company”) today announced that at the meeting of the Board of Directors held today...

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May 12, 2022

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, May 12, 2022 – 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...

Read more about Notice Regarding Continuation of the Performance-linked Stock Compensation Scheme and Performance-linked Stock Delivery Scheme for the Domestic and Global Astellas Group Executives
May 12, 2022

Astellas Highlights Data on Advanced and Rare Cancers during 2022 ASCO Annual Meeting and EHA 2022 Hybrid Congress

Abstracts represent exciting research progress across four cancers where patients have limited treatment options

TOKYO, May 12, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) will share new research during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from June 3-7 and the European Hematology Association...

Read more about Astellas Highlights Data on Advanced and Rare Cancers during 2022 ASCO Annual Meeting and EHA 2022 Hybrid Congress
May 6, 2022

Astellas to Present 12-Week Data from Pivotal Phase 3 SKYLIGHT 1™ Trial of Fezolinetant in Oral Session at the American College of Obstetricians and Gynecologists Annual Meeting

Astellas’ investigational nonhormonal treatment meets all primary endpoints, significantly reducing the frequency and severity of vasomotor symptoms associated with menopause

TOKYO, May 6, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) will present 12-week results from the pivotal Phase 3 SKYLIGHT 1™ clinical trial examining the efficacy and safety of fezolinetant, an investigational oral...

Read more about Astellas to Present 12-Week Data from Pivotal Phase 3 SKYLIGHT 1™ Trial of Fezolinetant in Oral Session at the American College of Obstetricians and Gynecologists Annual Meeting
Apr 27, 2022

Changes of Representative Director and Directors

TOKYO, April 27, 2022 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that at a meeting of its Board of Directors held today...

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Apr 25, 2022

University of Tokyo, Astellas Enter Second Phase of Strategic Partnership for Co-creation of Innovative New Medicines and Medical Solutions

TOKYO, April 25, 2022 – The University of Tokyo (President: Teruo Fujii, Ph.D.) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D.; hereafter “Astellas”) entered the second phase of their collaboration for co-creating innovative...

Read more about University of Tokyo, Astellas Enter Second Phase of Strategic Partnership for Co-creation of Innovative New Medicines and Medical Solutions
Apr 22, 2022

Notice Regarding Impairment Loss for Products under Development

TOKYO, April 22, 2022 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that it will book an impairment loss in the fourth quarter of the fiscal year ended March 31, 2022 (April 1, 2021 to March 31, 2022)...

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Apr 13, 2022

European Commission Approves PADCEV™ (enfortumab vedotin) for Locally Advanced or Metastatic Urothelial Cancer

- Enfortumab vedotin is the first medicine approved in the EU for patients who received a prior platinum-containing chemotherapy and a PD-1/L1 inhibitor -

TOKYO and BOTHELL, Wash. – April 13, 2022 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced that the European Commission (EC) has approved PADCEV™ (enfortumab vedotin)...

Read more about European Commission Approves PADCEV™ (enfortumab vedotin) for Locally Advanced or Metastatic Urothelial Cancer
Mar 15, 2022

Astellas Announces Topline 12-week Results from Phase 3 Study of Fezolinetant for the Nonhormonal Treatment of Vasomotor Symptoms in Women in Asia

Astellas’ MOONLIGHT 1™ clinical trial evaluating investigational fezolinetant 30 mg administered once daily

TOKYO, March 15, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced topline results from the ongoing Phase 3 MOONLIGHT 1™ clinical trial investigating the efficacy and safety of fezolinetant, an...

Read more about Astellas Announces Topline 12-week Results from Phase 3 Study of Fezolinetant for the Nonhormonal Treatment of Vasomotor Symptoms in Women in Asia
Mar 10, 2022

Astellas Announces Completion of 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, March 10, 2022 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the status and the completion of acquisition of its own shares based on the resolution of the Board of Directors' meeting held on February 2...

Read more about Astellas Announces Completion of Acquisition of Own Shares, and Cancellation of Treasury Stock
Mar 7, 2022

Astellas Announces Topline Results from Long-Term Phase 3 Safety Study of Fezolinetant which Inform Future Regulatory Filings for the Treatment of Vasomotor Symptoms Associated with Menopause

TOKYO, March 7, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced topline results from the Phase 3 SKYLIGHT 4™ clinical trial investigating the long-term safety of fezolinetant, an...

Read more about Astellas Announces Topline Results from Long-Term Phase 3 Safety Study of Fezolinetant which Inform Future Regulatory Filings for the Treatment of Vasomotor Symptoms Associated with Menopause
Mar 1, 2022

Astellas Announces Status of Acquisition of Own Shares

- Under the provision of its Articles of Incorporation in accordance with Article 459, paragraph 1 of the Companies Act -

TOKYO, March 1, 2022 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “the Company”) announced the status of acquisition of its own shares as stated below. The acquisition was implemented pursuant to the provision of its Articles of Incorporation in accordance with Article 459...

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Feb 28, 2022

Affinivax Reacquires Rights from Astellas for ASP3772, a Novel 24-valent Streptococcus pneumoniae Vaccine Candidate from Affinivax’s MAPS™ Platform

CAMBRIDGE, Mass, USA, and TOKYO, Japan, February 28, 2022 – Affinivax, Inc. (“Affinivax”) and Astellas Pharma Inc. (“Astellas”) today announced that they have entered into an agreement whereby Affinivax has reacquired the exclusive worldwide rights...

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Feb 28, 2022

Astellas and Seagen Announce CHMP Confirms Positive Opinion for PADCEV™ (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

TOKYO and BOTHELL, Wash. – February 28, 2022 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced that the Committee for Medicinal Products for Human Use...

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Feb 14, 2022

Astellas and Seagen Announce Initial Results of PADCEV® (enfortumab vedotin-ejfv) in Patients with Muscle-Invasive Bladder Cancer Not Eligible for Cisplatin Chemotherapy

– Late-breaking data from Cohort H of EV-103 trial to be presented at the 2022 ASCO Genitourinary Cancers Symposium –

TOKYO and BOTHELL, Wash. – February 14, 2022 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced the initial results from Cohort H of the EV-103 trial investigating...

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Feb 8, 2022

Astellas Announces Management Structure

TOKYO, February 8, 2022 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the following Top Management members effective from...

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Feb 7, 2022

Astellas Announces Positive Safety Data from the FORTIS Study of AT845 in Adults with Late-Onset Pompe Disease

- Data presented at the 18th Annual WORLDSymposiumTM 2022 -

TOKYO, Feb. 7, 2022 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive interim safety data from FORTIS, the Phase I/II clinical trial evaluating AT845, an investigational adeno-associated virus (AAV) gene...

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Feb 2, 2022

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, February 2, 2022 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that at the meeting of the Board of Directors held today, a resolution was adopted to acquire its own shares pursuant...

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Dec 18, 2021

FDA Grants Accelerated Approval to Astellas’ and Seattle Genetics’ PADCEV™ (enfortumab vedotin-ejfv) for People with Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer

- First-in-Class Antibody-Drug Conjugate Directed Against Nectin-4, a Protein Highly Expressed in Urothelial Tumors1,2

TOKYO and BOTHELL, Wash., December 18, 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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Dec 17, 2021

Astellas and Seagen Receive Positive CHMP Opinion for PADCEV™ (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

- If approved, PADCEV would be the first medicine for patients in the EU who have received prior platinum-based chemotherapy and a PD-1/L1 inhibitor -

TOKYO and BOTHELL, Wash. – December 17, 2021 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced that the Committee for Medicinal Products for Human Use...

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Dec 6, 2021

Astellas Applied for Selection of “Prime Market” segment of the Tokyo Stock Exchange

TOKYO, December 6 , 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today applied for selection of the “Prime Market” segment of the Tokyo Stock Exchange, Inc. (“TSE”) as its listing market as determined at the Board...

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Dec 2, 2021

Astellas and Dyno Therapeutics Announce Research Collaboration to Develop Next-Generation AAV Gene Therapy Vectors for Skeletal and Cardiac Muscle

- Dyno receives $18 million upfront and is eligible for milestone and royalty payments potentially exceeding $1.6 billion -

TOKYO and CAMBRIDGE, Mass., Dec. 2, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Dyno Therapeutics, Inc. (President and CEO: Eric Kelsic, Ph.D., “Dyno”) today announced an option and license agreement...

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Dec 1, 2021

Astellas to Present Research on FLT3 Mutation-Positive Acute Myeloid Leukemia – from Diagnosis to Relapse – at 2021 American Society of Hematology Annual Meeting

•Four AML oral presentations are among highest number of Astellas-sponsored ASH abstracts to date

TOKYO, Dec. 1, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the presentation of new investigational data in acute myeloid leukemia (AML) and sickle cell disease at the 63rd American Society...

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Nov 15, 2021

Astellas and Pantherna Enter into Technology Evaluation Agreement for Research of mRNA-based Regenerative Medicine

TOKYO and Hennigsdorf, Germany, November 15, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pantherna Therapeutics GmbH (CEO: Klaus Giese, Ph.D., “Pantherna”) today announced that the companies...

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Oct 20, 2021

Astellas Receives “2021 Award for Excellence in Corporate Disclosure” from the Securities Analysts Association of Japan

TOKYO, October 20, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that the company has ranked first in the pharmaceuticals sector for the “2021 Award for Excellence in Corporate Disclosure”...

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Oct 12, 2021

Astellas and Seagen Complete Enrollment in EV-103 Trial Cohort K Combining PADCEV® (enfortumab vedotin-ejfv) with Pembrolizumab as First-Line Treatment for Advanced Urothelial Cancer

TOKYO and BOTHELL, Wash. – October 12, 2021 – Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced that patient enrollment was completed in Cohort K of the phase 1b/2 EV-103...

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Oct 11, 2021

World's First Use of Environmentally Friendly Biomass-based Plastic for Blister Packages, the Primary Packaging for Drugs

TOKYO, October 11, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) begin using biomass-based plastics made from plant-derived materials in blister packages as the primary packaging for pharmaceutical products...

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Oct 1, 2021

Juntendo University and Astellas Establish "Direct Reprogramming Regenerative Medicine Course" for Scientific Breakthroughs

TOKYO, October 1, 2021 - Juntendo University (President: Hajime Arai, M.D., Ph.D.) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that the parties have established, inside Juntendo University Graduate School...

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Sep 27, 2021

Japan’s MHLW Approves PADCEV® (enfortumab vedotin) for Advanced Urothelial Cancer

- Enfortumab vedotin is the first and only antibody-drug conjugate (ADC) approved in Japan for patients with advanced urothelial cancer -

TOKYO and BOTHELL, Wash. – Sept. 27, 2021 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved PADCEV®...

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Sep 24, 2021

Tohoku University and Astellas Establish Second Phase of Comprehensive Industry-Academia Collaboration with Aim of Creating Innovative Healthcare Solutions

TOKYO and Sendai, Miyagi, September 24, 2021 - Tohoku University (President; Hideo Ohno, “Tohoku University”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) have established the second phase of comprehensive industry-...

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Sep 22, 2021

Astellas to Present Fezolinetant 12-Week Findings from Phase 3 SKYLIGHT 2™ Trial in Oral Session at The North American Menopause Society 2021 Annual Meeting

Astellas’ investigational non-hormonal treatment demonstrates reduction in frequency and severity of moderate to severe vasomotor symptoms (VMS) associated with menopause

TOKYO, September 22, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) will present 12-week results (S-13) from the pivotal Phase 3 SKYLIGHT 2™ clinical trial of fezolinetant for the treatment of moderate to severe vasomotor...

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Sep 21, 2021

Science-based Exercise at Home with Fit-eNce Home™ Pilot Sales Begins Today

TOKYO , September 21, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that it has begun the pilot sales of an exercise support service, Fit-eNce HomeTM, designed under the supervision of...

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Sep 17, 2021

Astellas’ and Pfizer’s XTANDI® (enzalutamide) Reduced Risk of Death by 34% in Men with Metastatic Hormone-Sensitive Prostate Cancer in Phase 3 ARCHES Study

Late-breaking abstract to be presented September 18 during European Society for Medical Oncology Congress 2021

TOKYO and NEW YORK, September 17, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) announced today ahead of the European Society for Medical Oncology (ESMO) Congress 2021 that XTANDI®...

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Sep 14, 2021

Astellas Reports Update to September 1 Announcement on the ASPIRO Clinical Trial of AT132 in Patients with X-linked Myotubular Myopathy

TOKYO, September 14, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) reports that the ASPIRO clinical trial participant, who developed a serious adverse event as described on September 1, passed away on September 9...

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Sep 2, 2021

Astellas, Nitto, and M. Heart Partnering for ECG testing service

-Total Solution for Early Detection of Atrial Fibrillation Using Disposable Holter ECG device and AI-Based Analysis Service-

TOKYO, OSAKA, and IWATE, September 2nd, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ), Nitto Denko Corporation (TSE: 6988, President; Hideo Takasaki, “Nitto”), and M. Heart Co., Ltd. (President and CEO: Yoshimi...

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Sep 1, 2021

Astellas Provides Update on ASPIRO Clinical Trial of AT132 in Patients with X-linked Myotubular Myopathy

TOKYO, September 1, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced that it has voluntarily paused screening and dosing of additional participants in its ASPIRO clinical trial evaluating AT132 in patients...

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Aug 31, 2021

Astellas Announces Personnel Changes

TOKYO, August 31, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO:
Kenji Yasukawa, Ph.D.) today announced that the personnel changes as below...

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Aug 20, 2021

Astellas Receives European Commission Approval for First-in-Class EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease

Roxadustat is the first orally administered hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) inhibitor available for adult patients with anemia associated with chronic kidney disease in Europe

TOKYO, August 20, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and FibroGen, Inc. (Nasdaq: FGEN, CEO: Enrique Conterno, "FibroGen") today announced that the European Commission (EC) has approved EVRENZOTM...

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Aug 6, 2021

Astellas Reforms Research Organization

- To become an agile organization where each drug discovery team autonomously creates VALUE -

TOKYO, August 6, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) will change its research organization as of October 1, 2021 as follows...

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Jul 30, 2021

Astellas and Minovia Therapeutics Announce Strategic Collaboration for Novel Mitochondrial Cell Therapy Programs

TOKYO, Japan, and Haifa, Israel, July 30, 2021 - Minovia Therapeutics, Ltd. (CEO; Natalie Yivgi-Ohana, Ph.D., “Minovia”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced a worldwide strategic collaboration...

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Jul 16, 2021

Begun Providing Holter ECG Analysis Service using AI

-Jointly Developed by Astellas and M. Heart-

TOKYO and Iwate, July 16, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and M. Heart Co., Ltd. (Headquarters: Iwate, President and CEO: Yoshimi Mizunuma, "M. Heart") launched "MYHOLTER II", a software for the holter...

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Jul 13, 2021

Affinivax and Astellas Present Safety and Immunogenicity Data from Phase 2 Study of ASP3772, a Novel 24 valent MAPS™ Vaccine for Streptococcus pneumoniae

Study results were selected for oral presentation at the 31st European Congress of Clinical Microbiology & Infectious Diseases (ECCMID)

CAMBRIDGE, Mass, USA, and TOKYO, Japan, July 13, 2021 -- Affinivax, Inc. ("Affinivax") and Astellas Pharma Inc. (“Astellas”) announced results from the Phase 2 clinical trial of ASP3772, a novel vaccine candidate targeting Streptococcus pneumoniae...

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Jul 13, 2021

Astellas Named to FTSE4Good Index Series for 10 Consecutive Years

TOKYO, July 13, 2021 – Astellas Pharma Inc. (President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that it has been named to the FTSE4Good Index Series for 10 consecutive years, as a company that is performing excellent initiatives in the areas of ESG...

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Jul 9, 2021

U.S. FDA Grants Regular Approval and Expands Indication for PADCEV® (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer

- Regular Approval Based on Overall Survival Results from Confirmatory EV-301 Trial -

TOKYO and BOTHELL, Wash.– July 9, 2021 -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced the U.S. Food and Drug Administration (FDA) granted PADCEV® (enfortumab vedotin-ejfv)...

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Jun 25, 2021

Astellas Receives Positive CHMP Opinion for EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease

TOKYO, June 25, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and FibroGen, Inc. (Nasdaq: FGEN, CEO: Enrique Conterno, "FibroGen") today announced the Committee for Medicinal Products for Human Use (CHMP)...

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Jun 17, 2021

Notice Regarding Impairment Loss Following the Termination of DNA Vaccine ASP0892 Development

TOKYO, June 17, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that it has decided to terminate the development of the DNA vaccine ASP0892, which is currently in Phase 1 study for peanut allergy...

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Jun 16, 2021

Astellas Transfers Five Legacy Products in Europe, Russia, CIS and Asia to Cheplapharm

TOKYO, June 16, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that Astellas and Cheplapharm Arzneimittel GmbH (“Cheplapharm”) have enterd into an Asset Purchase Agreement, under which Astellas will...

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Jun 8, 2021

New Research Reflects Astellas’ Commitment to Acute Myeloid Leukemia at EHA 2021 Virtual Congress

Eight abstracts cover FLT3 mutation-positive AML, patient treatment preferences and utilization in hard-to-treat blood cancer

TOKYO, June 8, 2021 – 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 the European Hematology Association (EHA) virtual congress...

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Jun 3, 2021

Reviewing capabilities for sustainable growth

-　 Astellas Will Offer an Early Retirement Incentive Program　-

TOKYO, June 3, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) is constantly reviewing its management resource allocation in order to respond flexibly to rapid changes in the business environment and strengthen...

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May 26, 2021

Astellas Announces New Corporate Strategic Plan 2021

Evolved strategy. Ambitious goals. Transformative execution. Same deep commitment to our VISION

TOKYO, May 26, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced its new Corporate Strategic Plan 2021 (“CSP2021”) for fiscal years 2021 through 2025...

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May 19, 2021

Astellas and Seagen Announce Updated Results from Two Trials of PADCEV® (enfortumab vedotin-ejfv) in Patients with Locally Advanced or Metastatic Urothelial Cancer Not Eligible for Cisplatin Chemotherapy

- Durable Responses Observed in Second Cohort of Patients in Pivotal EV-201 Trial of PADCEV and in Initial First-Line Cohort of the EV-103 Trial Evaluating PADCEV in Combination with KEYTRUDA® (pembrolizumab) -

TOKYO & BOTHELL, Wash. – May 19, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced updated results from two clinical trials examining PADCEV® (enfortumab vedotin-ejfv)...

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May 17, 2021

Astellas to Present Data from Expanding Oncology Portfolio During the 2021 ASCO Annual Meeting

Astellas’ ambitious innovation and committed collaboration support new research on investigational and approved therapies in hard-to-treat cancers

TOKYO, May 17, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) will share new data across its oncology portfolio during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting from June 4-8, 2021...

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May 14, 2021

Japan’s Ministry of Health, Labour and Welfare Grants Priority Review for Enfortumab Vedotin New Drug Application

NDA, submitted in March, is for locally advanced or metastatic urothelial cancer that has progressed after anti-cancer medication

TOKYO, May 14, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced Japan's Ministry of Health, Labour and Welfare (MHLW) has granted priority review for the company’s New Drug Application (NDA)...

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May 13, 2021

Astellas and Kyoto University Innovation Capital Establish Strategic Alliance Agreement

TOKYO and Kyoto, May 13, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) and Kyoto University Innovation Capital Co., Ltd. (President and CEO; Ko Kusumi, “KYOTO-iCAP”) have established a strategic alliance...

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May 12, 2021

Notice Regarding Continuation of the Performance-linked Stock Compensation Scheme

TOKYO, May 12, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “the Company”) today announced that at the meeting of the Board of Directors held today...

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May 4, 2021

Astellas’ XTANDI™ (enzalutamide) Approved by European Commission for Men with Metastatic Hormone-Sensitive Prostate Cancer

Enzalutamide is now the only oral therapy approved by the European Commission to treat three distinct types of advanced prostate cancer

TOKYO, May 4, 2021 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the European Commission (EC) has approved an additional indication for the oral once-daily therapy XTANDITM (enzalutamide)...

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Apr 27, 2021

Notice Regarding Impairment Loss for Investigational Gene Therapy AT132 and the Differences Between Financial Forecasts and Actual Results for the Fiscal Year Ended March 31, 2021

TOKYO, April 27, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that it booked an impairment loss in the fourth quarter of the fiscal year ended March 31, 2021 (April 1, 2020 to March 31, 2021)...

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Apr 27, 2021

Change of Directors

TOKYO, April 27, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that at a meeting of its Board of Directors held today...

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Apr 19, 2021

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

- Priority Review Granted with Action Date of August 17 -

TOKYO and BOTHELL, Wash. – April 19, 2021 -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced the U.S. Food and Drug Administration (FDA) filed two supplemental Biologics License...

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Apr 5, 2021

Astellas and TOA EIYO Announce Termination of Distribution Agreement

TOKYO, April 5, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) and TOA EIYO Ltd. (President: Atsuo Takahashi, Ph.D., “TOA EIYO”) today announced that the both companies have agreed to terminate the distribution agreement...

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Apr 1, 2021

Astellas Announces Termination of Co-promotion with Viatris, Succession of Manufacturing and Marketing Approval, and Transfer of Distribution for Lipitor® Tablets

TOKYO, April 1, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) annouced that Astellas and Viatris Pharmaceuticals Japan Inc. (Country Manager: Sun-A Kim, “Viatris”) have agreed to end the co-promotion of a...

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Mar 31, 2021

Astellas and TB Alliance Enter into a New Collaborative Research Agreement to Identify Lead Compounds for the Treatment of Tuberculosis

TOKYO and New York, March 31, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) and TB Alliance (President and CEO: Mel Spigelman, M.D.), a non-profit organization dedicated to finding faster-acting and affordable drug...

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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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