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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

May 21, 2024

Astellas Announces a Collaboration with YASKAWA to Create an Innovative Cell Therapy Ecosystem through the Integration of Pharmaceutical and Robotics Technologies

- Focuses on digitizing cell manufacturing processes through robotics technology

TOKYO, May 21, 2024 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it signed a memorandum of understanding with YASKAWA Electric Corporation (YASKAWA) to begin...

Read more about Astellas Announces a Collaboration with YASKAWA to Create an Innovative Cell Therapy Ecosystem through the Integration of Pharmaceutical and Robotics Technologies
May 15, 2024

Notice Regarding Continuation of the Performance-linked Stock Compensation Scheme

TOKYO, May 15, 2024– Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “the Company”) today announced that at the meeting of the Board of Directors held today, a resolution...

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May 15, 2024

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 15, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “the Company”) announced that at the meeting of the Board of Directors...
held today, a resolution was passed to continue the Performance-linked Stock
Compensation Scheme for the Corporate Executives

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 14, 2024

Astellas Showcases Scientific Advancements Across its Oncology Portfolio at 2024 ASCO Annual Meeting

16 abstracts feature new data and post-hoc analyses of pivotal trials across several types of hard-to-treat cancers

TOKYO, May 13, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki
Okamura, “Astellas”) will share new research from across its innovative portfolio of approved and investigational cancer therapies during the 2024 American Society of Clinical Oncology...

Read more about Astellas Showcases Scientific Advancements Across its Oncology Portfolio at 2024 ASCO Annual Meeting
May 2, 2024

Astellas and Poseida Therapeutics Enter Into Research Collaboration and License Agreement to Develop Novel Allogeneic Cell Therapies in Oncology

- Leverages Poseida’s proprietary allogeneic CAR-T platform to develop innovative convertibleCAR® programs targeting solid tumors -

TOKYO and SAN DIEGO, May 1, 2024 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Poseida Therapeutics, Inc. (NASDAQ: PSTX, President and CEO: Kristin Yarema, “Poseida”) today announced that Xyphos Biosciences, Inc., (a wholly...

Read more about Astellas and Poseida Therapeutics Enter Into Research Collaboration and License Agreement to Develop Novel Allogeneic Cell Therapies in Oncology
Apr 25, 2024

Change of Directors

TOKYO, April 25, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that at a meeting of its Board of Directors held today, it decided a change in Directors as stated below. This change is subject to approval at the 19th Term Annual Shareholders Meeting and a decision at the Board of Directors meeting...

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Apr 25, 2024

Change in Definition of Core Basis in Financial Results

TOKYO, April 25, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that at the meeting of the Board of Directors held today, it decided to change the definition of core basis in consolidated financial statements...

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Apr 23, 2024

Astellas’ XTANDI^TM (Enzalutamide) Granted European Commission Approval for Use in Additional Recurrent Early Prostate Cancer Treatment Setting

•XTANDI is now the first and only novel hormone therapy available for the treatment of high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer in the European Union (EU)

TOKYO, April 23, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the European Commission (EC) has approved a label extension for XTANDITM (enzalutamide) as monotherapy or in combination with androgen deprivation therapy (ADT) for the treatment of...

Read more about Astellas’ XTANDI^TM (Enzalutamide) Granted European Commission Approval for Use in Additional Recurrent Early Prostate Cancer Treatment Setting
Apr 22, 2024

Astellas Confirms Unfavorable District Court Decision Concerning its Motion for a Preliminary Injunction Against Lupin and Zydus Generic Versions of Myrbetriq^TM

TOKYO, April 22, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) confirms the U.S. District Court for the District of Delaware has filed a Report and Recommendation that recommends denying Astellas’ motion for a preliminary injunction that sought to enjoin Lupin and Zydus from launching...

Read more about Astellas Confirms Unfavorable District Court Decision Concerning its Motion for a Preliminary Injunction Against Lupin and Zydus Generic Versions of Myrbetriq^TM
Apr 22, 2024

Takeda, Astellas and Sumitomo Mitsui Banking Announce Master Agreement to Establish Joint Venture Company for Incubation of Early Drug Discovery Programs

Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK, President and CEO; Christophe Weber, “Takeda”), Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”), and Sumitomo Mitsui Banking Corporation (President & CEO: Akihiro Fukutome, “SMBC”) today announced...

Read more about Takeda, Astellas and Sumitomo Mitsui Banking Announce Master Agreement to Establish Joint Venture Company for Incubation of Early Drug Discovery Programs
Apr 12, 2024

Notice Regarding Impairment Loss for intangible assets, Change in fair value of contingent consideration, and Revision of Financial Forecasts for FY2023

TOKYO, April12, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it expects to book approximately ¥70.0 billion in the fourth quarter of fiscal year 2023 for an impairment loss for intangible assets and change in fair value of contingent consideration...

Read more about Notice Regarding Impairment Loss for intangible assets, Change in fair value of contingent consideration, and Revision of Financial Forecasts for FY2023
Apr 1, 2024

U.S. FDA Accepts Astellas’ Supplemental New Drug Application for IZERVAY^TM (avacincaptad pegol intravitreal solution) for Geographic Atrophy

- sNDA seeks to include positive 2-year data for IZERVAY -

TOKYO, April 1, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced it received notification from the U.S. Food and Drug Administration (FDA) of acceptance of the company’s supplemental New Drug Application (sNDA) to include positive...

Read more about U.S. FDA Accepts Astellas’ Supplemental New Drug Application for IZERVAY^TM (avacincaptad pegol intravitreal solution) for Geographic Atrophy
Mar 28, 2024

China’s National Medical Products Administration Accepts Astellas and Pfizer’s Supplemental Biologics License Application for enfortumab vedotin with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

- Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival vs platinum-containing chemotherapy-

TOKYO, March 28, 2024 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that on March 27, 2024 the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the supplemental Biologics License Application (sBLA) for...

Read more about China’s National Medical Products Administration Accepts Astellas and Pfizer’s Supplemental Biologics License Application for enfortumab vedotin with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer
Mar 26, 2024

Astellas’ VYLOY^TM (zolbetuximab) Approved in Japan for Treatment of Gastric Cancer

VYLOY approved in combination with chemotherapy for patients with human epidermal growth factor receptor 2 (HER2)-negative, CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer

TOKYO, March 26, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that on March 26, 2024, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved VYLOY™ (zolbetuximab), an anti-claudin 18.2 (CLDN18.2) monoclonal antibody for patients...

Read more about Astellas’ VYLOY^TM (zolbetuximab) Approved in Japan for Treatment of Gastric Cancer
Mar 22, 2024

Astellas Receives Positive CHMP Opinion for XTANDI^TM in Additional Recurrent Early Prostate Cancer Treatment Setting

- If approved, XTANDI would become the first and only NHT treatment available for metastatic and high risk biochemical recurrent non-metastatic hormone sensitive prostate cancer patient populations in the European Union (EU)

TOKYO, March 22, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of XTANDITM (enzalutamide) as monotherapy...

Read more about Astellas Receives Positive CHMP Opinion for XTANDI^TM in Additional Recurrent Early Prostate Cancer Treatment Setting
Mar 4, 2024

Astellas Initiates Phase 3 Clinical Studies of Fezolinetant for VMS Associated with Menopause in Japan

TOKYO, March 4, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced dosing of the first patient in the STARLIGHT™ 2 Phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of vasomotor symptoms...

Read more about Astellas Initiates Phase 3 Clinical Studies of Fezolinetant for VMS Associated with Menopause in Japan
Feb 16, 2024

Astellas and Kelonia Therapeutics Enter into Research and License Agreement to Develop Novel Immuno-Oncology Therapeutics

- Innovative universal, off-the-shelf in vivo CAR-T Cell therapy -

TOKYO and BOSTON, Mass., February 15, 2024 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Kelonia Therapeutics (CEO, Founder: Kevin Friedman, Ph.D., “Kelonia”) today announced that Xyphos Biosciences, Inc., (a wholly...

Read more about Astellas and Kelonia Therapeutics Enter into Research and License Agreement to Develop Novel Immuno-Oncology Therapeutics
Feb 15, 2024

PADCEV^TM (enfortumab vedotin (genetical recombination)) with KEYTRUDA^® (pembrolizumab (genetical recombination)) Granted Priority Review by Japan’s Ministry of Health, Labour and Welfare for First-Line Treatment of Advanced Bladder Cancer

- Priority review designation is based on results from the Phase 3 EV-302 trial, which found enfortumab vedotin plus pembrolizumab significantly extended overall survival and progression free survival compared to platinum-containing chemotherapy-

TOKYO, Feb. 15, 2024 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted priority review for the company’s Supplemental New Drug Application (sNDA) for PADCEV™ (enfortumab vedotin...

Read more about PADCEV^TM (enfortumab vedotin (genetical recombination)) with KEYTRUDA^® (pembrolizumab (genetical recombination)) Granted Priority Review by Japan’s Ministry of Health, Labour and Welfare for First-Line Treatment of Advanced Bladder Cancer
Feb 7, 2024

Astellas Makes Announcement about Management Structure

TOKYO, February 7, 2024 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the following changes to its management structure effective April 1, 2024...

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Jan 31, 2024

Astellas Announces Strategic Collaboration with Mass General Brigham

- Five-year collaboration to advance translational medicine and accelerate early development of novel therapies -

TOKYO, January 31, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) announced today that it has entered into a strategic collaboration with Mass General Brigham (President and CEO: Anne Klibanski, MD) that is focused on translational medicine and early development to establish...

Read more about Astellas Announces Strategic Collaboration with Mass General Brigham
Jan 31, 2024

Astellas Submits Supplemental New Drug Application in Japan for PADCEV^TM (enfortumab vedotin (genetical recombination) with KEYTRUDA^® (pembrolizumab (genetical recombination)) for First-Line Treatment of Advanced Bladder Cancer

– Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival vs platinum-containing chemotherapy–

TOKYO – January 31, 2024 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced the submission of a Supplemental New Drug Application (sNDA) on January 31 to Japan's Ministry of Health, Labour and Welfare (MHLW) for PADCEV™ (enfortumab vedotin...

Read more about Astellas Submits Supplemental New Drug Application in Japan for PADCEV^TM (enfortumab vedotin (genetical recombination) with KEYTRUDA^® (pembrolizumab (genetical recombination)) for First-Line Treatment of Advanced Bladder Cancer
Jan 26, 2024

European Medicines Agency Validates Type II Variation Application for PADCEV^TM (enfortumab vedotin) with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

– Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival –

TOKYO and NEW YORK.– Jan. 26, 2024 – Astellas Pharma Inc. (TSE:4503,President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced that on Jan. 26, 2024 the European Medicines Agency (EMA) validated for review a Type II variation application for PADCEVTM (enfortumab vedotin)...

Read more about European Medicines Agency Validates Type II Variation Application for PADCEV^TM (enfortumab vedotin) with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer
Jan 8, 2024

Astellas Provides Update on Zolbetuximab Biologics License Application in U.S.

TOKYO, January 8, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the U.S. Food and Drug Administration (FDA) issued a complete response letter on January 4, 2024, regarding the Biologics License Application (BLA) for zolbetuximab, an investigational agent...

Read more about Astellas Provides Update on Zolbetuximab Biologics License Application in U.S.
Dec 28, 2023

Elpiscience and Astellas Enter into Research Collaboration and License Agreement for Novel Bispecific Macrophage Engager

Shanghai and Suzhou, TOKYO, December 28, 2023 - Elpiscience Biopharma, Ltd. (Chairman and CEO: Darren Ji, MD, Ph.D., “Elpiscience”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced a research collaboration and license agreement for novel bispecific...

Read more about Elpiscience and Astellas Enter into Research Collaboration and License Agreement for Novel Bispecific Macrophage Engager
Dec 22, 2023

Astellas Completes Acquisition of Propella Therapeutics

TOKYO, December 22, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) announced today that it has completed the acquisition of Propella Therapeutics, Inc. (President and CEO: William Moore, “Propella”), and has become a wholly owned subsidiary of Astellas...

Read more about Astellas Completes Acquisition of Propella Therapeutics
Dec 18, 2023

EMA Recommends Arpraziquantel for Treatment of Schistosomiasis in Preschool-Aged Children

- Astellas contributed to the development of a pediatric formulation to treat schistosomiasis as a member of the Pediatric Praziquantel Consortium -

TOKYO, December 18, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) contributed to the development of a pediatric formulation to treat schistosomiasis as a member of the Pediatric Praziquantel Consortium (Consortium). The Consortium announced that the Committee...

Read more about EMA Recommends Arpraziquantel for Treatment of Schistosomiasis in Preschool-Aged Children
Dec 15, 2023

PADCEV^® (enfortumab vedotin-ejfv) with KEYTRUDA^® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer

– PADCEV plus pembrolizumab approved based on groundbreaking EV-302 trial –

TOKYO and NEW YORK – December 15, 2023 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced that on December 15, 2023 the U.S. Food and Drug Administration (FDA) has approved PADCEV® (enfortumab vedotin-ejfv, an antibody-drug conjugate...

Read more about PADCEV^® (enfortumab vedotin-ejfv) with KEYTRUDA^® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer
Dec 11, 2023

Astellas’ VEOZA^TM (fezolinetant) Approved by European Commission for Treatment of Vasomotor Symptoms Associated with Menopause

First-in-class treatment option reduces number and intensity of hot flashes and night sweats

TOKYO, December 11, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the European Commission (EC) on December 7 approved VEOZATM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause...

Read more about Astellas’ VEOZA^TM (fezolinetant) Approved by European Commission for Treatment of Vasomotor Symptoms Associated with Menopause
Nov 30, 2023

Astellas’ Fezolinetant Reduces Frequency and Severity of VMS Associated with Menopause in Women Considered Unsuitable for Hormone Therapy

Phase 3b DAYLIGHT study being presented at ESG 2023 demonstrated fezolinetant 45 mg achieved statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms due to menopause and patient-reported sleep disturbance at 24 weeks

TOKYO, November 30, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) will present 24-week results from the Phase 3b DAYLIGHT clinical trial examining the efficacy and safety of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of...

Read more about Astellas’ Fezolinetant Reduces Frequency and Severity of VMS Associated with Menopause in Women Considered Unsuitable for Hormone Therapy
Nov 30, 2023

FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV^® (enfortumab vedotin-ejfv) with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

– Results of pivotal confirmatory trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall survival and progression-free survival vs standard platinum containing chemotherapy–

TOKYO and BOTHELL, Wash.– November 30, 2023 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) and Seagen Inc. (Nasdaq: SGEN) today announced that on November 30, 2023 the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as a combination therapy for the treatment...

Read more about FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV^® (enfortumab vedotin-ejfv) with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer
Nov 16, 2023

University of Tsukuba and Astellas Confirm a Strategic Partnership

- Accelerating the development of the life science ecosystem centered on Tsukuba -

TOKYO and IBARAKI, November 16, 2023 - University of Tsukuba (President: Kyosuke Nagata) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that they have signed a letter of confirmation regarding a strategic partnership to accelerate the digitalization of the drug...

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Nov 16, 2023

Pfizer and Astellas' XTANDI^® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting

XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy* in nonmetastatic castration-sensitive prostate cancer

TOKYO and NEW YORK, November 16, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application for XTANDI®...

Read more about Pfizer and Astellas' XTANDI^® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting
Nov 15, 2023

Astellas to Acquire Propella Therapeutics

- Acquire PRL-02, prostate cancer treatment program being developed by Propella Therapeutics -

TOKYO and PITTSBORO, N.C., November 15, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Propella Therapeutics, Inc. (President and CEO: William Moore, “Propella”) today announced that Astellas, through a US subsidiary, and Propella have entered into a merger agreement...

Read more about Astellas to Acquire Propella Therapeutics
Nov 15, 2023

Astellas Announces Data from ASPIRO Study in X-linked Myotubular Myopathy Published in The Lancet Neurology

Preliminary data analysis on ventilator dependence and motor improvement are reported alongside overall safety findings

TOKYO, November 15, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that The Lancet Neurology published a preliminary data analysis from the ASPIRO trial, evaluating the safety and efficacy of investigational AT132 (resamirigene bilparvovec), an adeno-associated...

Read more about Astellas Announces Data from ASPIRO Study in X-linked Myotubular Myopathy Published in The Lancet Neurology
Nov 4, 2023

IZERVAY^TM (avacincaptad pegol intravitreal solution) Monthly or Every Other Month Reduced Geographic Atrophy Lesion Growth Through 2 Years

-Phase 3 results presented at the AAO Annual Meeting demonstrated the IZERVAY treatment effect more than doubled over 2 years compared to 1 year-

TOKYO, November 4, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced results from the GATHER2 Phase 3 clinical trial, demonstrating IZERVAY™ (avacincaptad pegol intravitreal solution) continued to reduce the rate of geographic atrophy (GA) lesion growth for both...

Read more about IZERVAY^TM (avacincaptad pegol intravitreal solution) Monthly or Every Other Month Reduced Geographic Atrophy Lesion Growth Through 2 Years
Oct 25, 2023

Astellas Ranked First in Pharmaceuticals Sector of “2023 Award for Excellence in Corporate Disclosure” by Securities Analysts Association of Japan

TOKYO, October 25, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the company has ranked first in the pharmaceuticals sector for the “2023 Award for Excellence in Corporate Disclosure” granted by the Securities Analysts Association of Japan (SAAJ) to...

Read more about Astellas Ranked First in Pharmaceuticals Sector of “2023 Award for Excellence in Corporate Disclosure” by Securities Analysts Association of Japan
Oct 22, 2023

Groundbreaking EV-302 Trial Significantly Extends Overall Survival and Progression-Free Survival in Patients Treated with PADCEV^®(enfortumab vedotin-ejfv) and KEYTRUDA^® (pembrolizumab) in First-Line Advanced Bladder Cancer

– Risk of death was reduced by 53% in patients treated with enfortumab vedotin plus pembrolizumab compared to chemotherapy –

TOKYO and BOTHELL, Wash. – October 22, 2023 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) and Seagen Inc. (Nasdaq: SGEN) today announced results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) for PADCEV® (enfortumab vedotin-ejfv) in combination...

Read more about Groundbreaking EV-302 Trial Significantly Extends Overall Survival and Progression-Free Survival in Patients Treated with PADCEV^®(enfortumab vedotin-ejfv) and KEYTRUDA^® (pembrolizumab) in First-Line Advanced Bladder Cancer
Oct 15, 2023

Astellas to Share New Data Across Hard-to-Treat Cancers During ESMO Congress 2023

Data include three late-breaking abstracts, underscoring Astellas’ efforts to potentially redefine expectations for patients across its oncology portfolio

TOKYO, Oct 15, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) will share new research results during the European Society for Medical Oncology (ESMO) Congress 2023 from October 20-24, showcasing the company’s focus on making a meaningful difference for people living with...

Read more about Astellas to Share New Data Across Hard-to-Treat Cancers During ESMO Congress 2023
Oct 13, 2023

Astellas Receives Positive CHMP Opinion for VEOZA^TM (fezolinetant)

Fezolinetant is an investigational nonhormonal treatment for vasomotor symptoms (VMS) associated with menopause

TOKYO, October 13, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on October 12 adopted a positive opinion relating to the use of VEOZA™ (fezolinetant) 45 mg...

Read more about Astellas Receives Positive CHMP Opinion for VEOZA^TM (fezolinetant)
Oct 10, 2023

Astellas, BioLabs and Mitsui Fudosan Announce a Collaboration to Enhance the Life Science Ecosystems in Tsukuba and Kashiwa-no-ha, Japan

- Open Innovation Hub Named SakuLabTM-Tsukuba will open at the Astellas Tsukuba Research Center -

TOKYO and Boston, MA October 10, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and BioLabs Global, Inc. (Founder and CEO: Johannes Fruehauf, “BioLabs”) and Mitsui Fudosan (TSE: 8801, President and CEO: Takashi Ueda, “Mitsui Fudosan”) today announced that they have agreed...

Read more about Astellas, BioLabs and Mitsui Fudosan Announce a Collaboration to Enhance the Life Science Ecosystems in Tsukuba and Kashiwa-no-ha, Japan
Sep 28, 2023

Astellas Announces Personnel Change

TOKYO, September 28, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the following personnel change in its top management effective from...

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Sep 22, 2023

PADCEV^® (enfortumab vedotin-ejfv) and KEYTRUDA^® (pembrolizumab) Significantly Improve Overall Survival and Progression-Free Survival in Patients With Previously Untreated Advanced Bladder Cancer in Pivotal Phase 3 EV-302 Trial

– Trial results to be submitted for presentation at upcoming medical meeting –

TOKYO and BOTHELL, Wash. – September 22, 2023 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) and Seagen Inc. (Nasdaq: SGEN) today announced positive topline results from the Phase 3 EV-302 clinical trial (also known as...

Read more about PADCEV^® (enfortumab vedotin-ejfv) and KEYTRUDA^® (pembrolizumab) Significantly Improve Overall Survival and Progression-Free Survival in Patients With Previously Untreated Advanced Bladder Cancer in Pivotal Phase 3 EV-302 Trial
Sep 19, 2023

Astellas Highlights VEOZAH^TM (fezolinetant) Data at the 2023 Annual Meeting of The Menopause Society

Pooled analyses from pivotal Phase 3 SKYLIGHT^TMstudies provide new insights into fezolinetant for the treatment of moderate to severe VMS due to menopause

TOKYO, September 19, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) will share new pooled efficacy and safety analyses from the pivotal Phase 3 SKYLIGHT™ studies for VEOZAH™ (fezolinetant), its first-in-class treatment for moderate to severe vasomotor...

Read more about Astellas Highlights VEOZAH^TM (fezolinetant) Data at the 2023 Annual Meeting of The Menopause Society
Sep 19, 2023

China’s National Medical Products Administration Accepts New Drug Application for XTANDI^®(enzalutamide) in Metastatic Hormone-Sensitive Prostate Cancer

TOKYO, September 19, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted its New Drug...

Read more about China’s National Medical Products Administration Accepts New Drug Application for XTANDI^®(enzalutamide) in Metastatic Hormone-Sensitive Prostate Cancer
Sep 18, 2023

Iveric Bio Announces Positive 24-Month Topline Results from Phase 3 Study of IZERVAY^TM (avacincaptad pegol intravitreal solution) for Geographic Atrophy

GATHER2 24-month results met the primary objective of reducing the rate of GA growth in patients treated with IZERVAY compared to sham

TOKYO, September 18, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced positive 24-month topline results from the Phase 3 GATHER2 clinical trial evaluating the efficacy and safety of IZERVAY™...

Read more about Iveric Bio Announces Positive 24-Month Topline Results from Phase 3 Study of IZERVAY^TM (avacincaptad pegol intravitreal solution) for Geographic Atrophy
Sep 14, 2023

Astellas to Invest more than €330 Million in a New State-of-the-Art Facility in Tralee, Co. Kerry. Ireland

- Investment will build capabilities to supply the Astellas global market and accelerate the development and commercialisation of innovative medicines-

TOKYO, September 14, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced its intention to submit a planning application to build a new state-of-the-art facility, at an approximate cost of €330 million in Tralee, Co. Kerry...

Read more about Astellas to Invest more than €330 Million in a New State-of-the-Art Facility in Tralee, Co. Kerry. Ireland
Sep 12, 2023

European Medicines Agency Validates Type II Variation for Astellas' XTANDI^® (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence

Application based on results from Phase 3 EMBARK trial, which showed XTANDI plus leuprolide reduced risk of metastasis or death by 58%

TOKYO, September 12, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the European Medicines Agency (EMA) has validated its Type II variation for XTANDI® (enzalutamide) for the treatment of patients with non-metastatic...

Read more about European Medicines Agency Validates Type II Variation for Astellas' XTANDI^® (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence
Aug 25, 2023

Notice Regarding Issuance of Unsecured Bonds

TOKYO, August 25, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) successfully priced a dual-tranche of series 3rd and 4th JPY denominated unsecured bonds...

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Aug 23, 2023

FDA Grants Priority Review for XTANDI^® in Non-Metastatic Castration-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence

If approved, XTANDI would become the first and only novel hormone therapy approved in this earlier type of prostate cancer

NEW YORK and TOKYO, August 23, 2023 – Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the companies’ supplemental...

Read more about FDA Grants Priority Review for XTANDI^® in Non-Metastatic Castration-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence
Aug 18, 2023

European Medicines Agency Accepts Iveric Bio’s Marketing Authorization Application for Avacincaptad Pegol for Geographic Atrophy

TOKYO, August 18, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”), today announced the European Medicines Agency (EMA) has accepted for regulatory review the marketing authorization application (MAA) for avacincaptad pegol...

Read more about European Medicines Agency Accepts Iveric Bio’s Marketing Authorization Application for Avacincaptad Pegol for Geographic Atrophy
Aug 9, 2023

Astellas to Open New Life Sciences Facility in DivcoWest’s Cambridge Crossing Neighborhood

TOKYO and SAN FRANCISCO, August 9, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and DivcoWest, a DivCore Capital Company, announced today plans for Astellas to open a new state-of-the-art life sciences facility at 441 Morgan Avenue, in the Cambridge Crossing...

Read more about Astellas to Open New Life Sciences Facility in DivcoWest’s Cambridge Crossing Neighborhood
Aug 7, 2023

Astellas and Poseida Therapeutics Announce Strategic Investment to Support Poseida’s Commitment to Redefining Cancer Cell Therapy

Poseida is a clinical-stage biotechnology company dedicated to advancing a new class of cancer cell therapy and gene therapy products using genetic engineering technologies

TOKYO and SAN DIEGO, August, 7, 2023 -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Poseida Therapeutics, Inc. (NASDAQ: PSTX, CEO: Mark Gergen, "Poseida") today announced a strategic investment to support the advancement of Poseida's commitment to redefining cancer cell therapy...

Read more about Astellas and Poseida Therapeutics Announce Strategic Investment to Support Poseida’s Commitment to Redefining Cancer Cell Therapy
Aug 5, 2023

Iveric Bio Receives U.S. FDA Approval for IZERVAY^TM (avacincaptad pegol intravitreal solution), a New Treatment for Geographic Atrophy

IZERVAY is the only approved GA treatment with a statistically significant reduction in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials

TOKYO, August 5, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”), today announced the U.S. Food and Drug Administration (FDA) approved IZERVAY™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary...

Read more about Iveric Bio Receives U.S. FDA Approval for IZERVAY^TM (avacincaptad pegol intravitreal solution), a New Treatment for Geographic Atrophy
Aug 1, 2023

Transforming Astellas Japan Commercial business to deliver growth for the future

TOKYO, August 1, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) constantly reviews its allocation of managerial resources, in order to adapt flexibly to the rapidly changing business environment and to reinforce its medium...

Read more about Transforming Astellas Japan Commercial business to deliver growth for the future
Jul 31, 2023

China’s National Medical Products Administration Accepts Astellas’ Biologics License Application for Zolbetuximab

TOKYO, July 31, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the Biologics License...

Read more about China’s National Medical Products Administration Accepts Astellas’ Biologics License Application for Zolbetuximab
Jul 25, 2023

Astellas and PeptiDream Enter into Research Collaboration and License Agreement to Discover Novel Targeted Protein Degraders

TOKYO and KANAGAWA, July 25, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and PeptiDream Inc. (TSE: 4587, President and CEO: Patrick C. Reid, “PeptiDream”) today announced a research collaboration and license agreement...

Read more about Astellas and PeptiDream Enter into Research Collaboration and License Agreement to Discover Novel Targeted Protein Degraders
Jul 18, 2023

Astellas and Eko Health Announce Agreement to Incorporate Next Generation Eko CORE 500^TM Digital Stethoscope into Z1608, an Innovative Solution Under Development for Heart Failure Patients Built on Welldoc’s Proven Digital Therapeutic Platform

TOKYO, Emeryville, California and Columbia, Maryland, July 18, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Eko Health Inc. (Co-Founder and CEO: Connor Landgraf, “Eko”) announced today that they have entered into a License & Supply Agreement...

Read more about Astellas and Eko Health Announce Agreement to Incorporate Next Generation Eko CORE 500^TM Digital Stethoscope into Z1608, an Innovative Solution Under Development for Heart Failure Patients Built on Welldoc’s Proven Digital Therapeutic Platform
Jul 13, 2023

European Medicines Agency Accepts Astellas’ Marketing Authorization Application for Zolbetuximab

TOKYO, July 13, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the European Medicines Agency (EMA) has accepted for regulatory review the company’s marketing authorization application (MAA) for...

Read more about European Medicines Agency Accepts Astellas’ Marketing Authorization Application for Zolbetuximab
Jul 11, 2023

Astellas Completes Acquisition of Iveric Bio

Tokyo and Parsippany, New Jersey, July 11, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it has successfully completed the acquisition of IVERIC bio, Inc. (NASDAQ: ISEE, CEO: Glenn P. Sblendorio, “Iveric...

Read more about Astellas Completes Acquisition of Iveric Bio
Jul 10, 2023

Astellas and 4D Molecular Therapeutics (4DMT) Enter into License Agreement to Use 4DMT’s Proprietary Intravitreal R100 Vector for Rare Ophthalmic Targets

TOKYO and EMERYVILLE, Calif., July 10, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and 4D Molecular Therapeutics, Inc. (NASDAQ: FDMT, CEO: David Kirn, MD, “4DMT”) today announced a license agreement under which...

Read more about Astellas and 4D Molecular Therapeutics (4DMT) Enter into License Agreement to Use 4DMT’s Proprietary Intravitreal R100 Vector for Rare Ophthalmic Targets
Jul 6, 2023

Astellas Announces U.S. FDA Grants Priority Review for Zolbetuximab Biologics License Application

If approved, the investigational therapy would offer a new treatment option for patients with advanced gastric and gastroesophageal cancers

TOKYO, July 6, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company’s Biologics License Application (BLA) for zolbetuximab, a first-in-class...

Read more about Astellas Announces U.S. FDA Grants Priority Review for Zolbetuximab Biologics License Application
Jun 29, 2023

Astellas Establishes Open Innovation Hub for Tumor Microenvironment Research with Cutting-Edge Spatial Biology, in Mitsui Fudosan’s “MITSUI LINK-Lab KASHIWA-NO-HA 1”

TOKYO, June 29, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Mitsui Fudosan Co., Ltd. (TSE: 8801, President and CEO: Takashi Ueda, “Mitsui Fudosan”) announced today that Astellas will establish...

Read more about Astellas Establishes Open Innovation Hub for Tumor Microenvironment Research with Cutting-Edge Spatial Biology, in Mitsui Fudosan’s “MITSUI LINK-Lab KASHIWA-NO-HA 1”
Jun 27, 2023

Phase 3b Trial of Fezolinetant Shows Positive Topline Results for Treatment of VMS Due to Menopause

Study evaluated 24-week efficacy and safety of Astellas’ fezolinetant in women considered unsuitable for hormone therapy

TOKYO, June 27, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced positive topline results from the Phase 3b DAYLIGHT clinical trial for fezolinetant, an investigational oral, nonhormonal...

Read more about Phase 3b Trial of Fezolinetant Shows Positive Topline Results for Treatment of VMS Due to Menopause
Jun 14, 2023

Astellas and Cullgen Enter into Strategic Collaboration and Option Agreement to Advance Innovative Targeted Protein Degraders

TOKYO and SAN DIEGO, June 14, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Cullgen Inc. (President and CEO: Ying Luo, Ph.D., “Cullgen”) today announced a research collaboration and exclusive option agreement to discover multiple innovative protein degraders...

Read more about Astellas and Cullgen Enter into Strategic Collaboration and Option Agreement to Advance Innovative Targeted Protein Degraders
Jun 12, 2023

Astellas Confirms Unfavorable District Court Decision in Myrbetriq^® U.S. Patent Trial

TOKYO, June 12, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) confirmed the U.S. District Court for the District of Delaware issued a decision on June 9 finding U.S. Patent No. 10,842,780...

Read more about Astellas Confirms Unfavorable District Court Decision in Myrbetriq^® U.S. Patent Trial
Jun 9, 2023

Astellas Submits New Drug Application for Zolbetuximab in Japan

Ministry of Health, Labour and Welfare to evaluate zolbetuximab as treatment option for patients with advanced gastric and gastroesophageal cancers

TOKYO, June 9, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the submission of a New Drug Application (NDA) on June 9, 2023 to Japan's Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab...

Read more about Astellas Submits New Drug Application for Zolbetuximab in Japan
Jun 9, 2023

Gilteritinib as Maintenance Therapy Demonstrated Benefit in Subgroups of FLT3-ITD Acute Myeloid Leukemia Patients

Data from Phase 3 MORPHO trial selected for press briefing and to be presented as oral session during the 2023 European Hematology Association (EHA) Hybrid Congress

TOKYO and ROCKVILLE, Md., June 9, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) today presented data from the Phase 3 MORPHO clinical trial which demonstrated favorable results in subgroups...

Read more about Gilteritinib as Maintenance Therapy Demonstrated Benefit in Subgroups of FLT3-ITD Acute Myeloid Leukemia Patients
Jun 8, 2023

Astellas and Kate Therapeutics Announce Exclusive License Agreement for KT430

KT430 is a preclinical, next-generation investigational gene therapy to treat X-linked myotubular myopathy (XLMTM)

TOKYO and SAN DIEGO, June 8, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”), and Kate Therapeutics (“KateTx”) today announced an exclusive license agreement to develop and commercialize KT430. KT430 is a preclinical next-generation...

Read more about Astellas and Kate Therapeutics Announce Exclusive License Agreement for KT430
May 25, 2023

Astellas announces the intended decision to transfer its manufacturing plant and business based in Meppel, the Netherlands, to Delpharm

TOKYO, May 25, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that Astellas B.V. and Astellas Pharma Europe B.V., Astellas’ subsidiaries in Netherlands, have made an intended decision...

Read more about Astellas announces the intended decision to transfer its manufacturing plant and business based in Meppel, the Netherlands, to Delpharm
May 25, 2023

Astellas Announces Commitments to 3rd Phase of GHIT Fund Replenishment

TOKYO, May 25, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it has committed to supporting the 3rd phase of the Global Health Innovative Technology Fund...

Read more about Astellas Announces Commitments to 3rd Phase of GHIT Fund Replenishment
May 25, 2023

Astellas Highlights Continued Delivery of Strong Cancer Portfolio and Pipeline at 2023 ASCO Annual Meeting

Data at meeting illustrate company’s progress in addressing unmet needs in a broad range of hard-to-treat solid tumors and hematologic malignancies

TOKYO, May 25, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki
Okamura, “Astellas”) will share new research from across its expanding portfolio of approved
and investigational cancer therapies during the 2023 American Society of Clinical Oncology...

Read more about Astellas Highlights Continued Delivery of Strong Cancer Portfolio and Pipeline at 2023 ASCO Annual Meeting
May 17, 2023

Notice Regarding Continuation of the Performance-linked Stock Compensation Scheme

TOKYO, May 17, 2023– Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “the Company”) today 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
May 17, 2023

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 17, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “the Company”) announced that at the meeting of the Board of Directors held today, a resolution was passed to continue...

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 16, 2023

Sony and Astellas Enter into Collaborative Research Agreement to Discover a Novel ADC Platform for the Oncology Field

- Conduct collaborative research on Sony’s unique polymeric materials to achieve high-DAR ADC -

TOKYO, May 16, 2023 – Sony Corporation (President and CEO: Kimio Maki, “Sony”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that they have entered into a collaborative research agreement to discover a novel Antibody-Drug Conjugate...

Read more about Sony and Astellas Enter into Collaborative Research Agreement to Discover a Novel ADC Platform for the Oncology Field
May 13, 2023

Astellas’ VEOZAH^TM (fezolinetant) Approved by U.S. FDA for Treatment of Vasomotor Symptoms Due to Menopause

VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause

TOKYO, May 13 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has approved VEOZAHTM (fezolinetant) 45 mg once daily for the treatment...

Read more about Astellas’ VEOZAH^TM (fezolinetant) Approved by U.S. FDA for Treatment of Vasomotor Symptoms Due to Menopause
May 11, 2023

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

TOKYO, May 11, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today confirmed that the Court of Appeals for the Federal Circuit (CAFC) issued a Mandate that officially ends the CAFC appeal on patent infringement...

Read more about Astellas Confirms Final Federal Circuit Decision in LEXISCAN^®0.4 mg/mL U.S. Patent Appeal
Apr 30, 2023

Astellas Enters into Definitive Agreement to Acquire Iveric Bio

-Companies to Create World-Class Ophthalmology Entity-

Tokyo and Parsippany, New Jersey, April 30, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Iveric bio, Inc. (NASDAQ: ISEE, CEO: Glenn P. Sblendorio, “Iveric Bio”) today announced that on April 29, 2023...

Read more about Astellas Enters into Definitive Agreement to Acquire Iveric Bio
Apr 29, 2023

XTANDI^® (enzalutamide) plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide

Data from Phase 3 EMBARK trial to be presented as a plenary session during the 2023 American Urological Association Annual Meeting

TOKYO and NEW YORK, April 29, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) announced today that XTANDI® (enzalutamide) plus leuprolide significantly reduced the risk of metastasis...

Read more about XTANDI^® (enzalutamide) plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide
Apr 27, 2023

Changes of Representative Director and Directors

TOKYO, April 27, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that at a meeting of its Board of Directors held today, it decided changes of...

Read more about Changes of Representative Director and Directors
Apr 14, 2023

Results from Astellas’ Phase 3 SPOTLIGHT Trial of Investigational Zolbetuximab Published in The Lancet

TOKYO, April 14, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that The Lancet published detailed data from the Phase 3 SPOTLIGHT trial evaluating first-line treatment with zolbetuximab, an investigational first-in-class Claudin...

Read more about Results from Astellas’ Phase 3 SPOTLIGHT Trial of Investigational Zolbetuximab Published in The Lancet
Apr 12, 2023

CiRA, Kyoto University and Astellas Second Phase Joint Research Agreement Signed for Medical Applications of iPS Cells

Kyoto and Tokyo, April 12, 2023 - The Center for iPS Cell Research and Application, Kyoto University (Director: Dr. Jun Takahashi; “CiRA”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) entered into the second phase...

Read more about CiRA, Kyoto University and Astellas Second Phase Joint Research Agreement Signed for Medical Applications of iPS Cells
Apr 11, 2023

Notice Regarding Impairment Loss and Revision of Financial Forecasts for FY2022

TOKYO, April 11, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it expects to book an impairment loss of approximately ¥58.0 billion as other expenses in the fourth quarter of fiscal year 2022...

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Apr 3, 2023

FDA Grants Accelerated Approval for PADCEV^®(enfortumab vedotin-ejfv) with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Locally Advanced or Metastatic Urothelial Cancer

– First treatment option combining an antibody-drug conjugate plus a PD-1 inhibitor in this patient population –

TOKYO and BOTHELL, Wash. – April 3, 2023 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) and Seagen Inc. (Nasdaq: SGEN) today announced the U.S. Food and Drug Administration (FDA) has granted PADCEV®...

Read more about FDA Grants Accelerated Approval for PADCEV^®(enfortumab vedotin-ejfv) with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Locally Advanced or Metastatic Urothelial Cancer
Mar 29, 2023

Astellas and Roche Diabetes Care Japan ink partnership agreement to develop and commercialize integrated diabetes self-management solution with BlueStar^®

- Accu-Chek® Guide Me glucose meter to be paired with BlueStar® in Japan, which is being jointly developed by Astellas and Welldoc -

TOKYO and Columbia, Maryland, March 29, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that it has entered into an agreement ("the Agreement") with Roche Diabetes Care Japan Co., Ltd...

Read more about Astellas and Roche Diabetes Care Japan ink partnership agreement to develop and commercialize integrated diabetes self-management solution with BlueStar^®
Mar 28, 2023

Astellas Announces Personnel Change

TOKYO, March 28, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO:
Kenji Yasukawa, Ph.D.) today announced the following personnel change...

Read more about Astellas Announces Personnel Change
Mar 22, 2023

Astellas Announces Positive Findings from Phase 3 GLOW Trial of Zolbetuximab during March ASCO Plenary Series

Data shows investigational zolbetuximab plus CAPOX reduced risk of progression or death by 31.3% vs CAPOX alone

TOKYO, March 22, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) will present detailed results from the Phase 3 GLOW trial evaluating first-line treatment with zolbetuximab, an investigational first-in-class Claudin...

Read more about Astellas Announces Positive Findings from Phase 3 GLOW Trial of Zolbetuximab during March ASCO Plenary Series
Mar 17, 2023

Phase 3 Study Shows XTANDI^® (enzalutamide) plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer

Pfizer and Astellas announce positive topline results from Phase 3 EMBARK trial

NEW YORK and TOKYO, March 17, 2023 – Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline...

Read more about Phase 3 Study Shows XTANDI^® (enzalutamide) plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer
Mar 16, 2023

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 16, 2023 – 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...

Read more about Astellas Announces Completion of Acquisition of Own Shares, and Cancellation of Treasury Stock
Mar 14, 2023

Astellas Announces Phase 3 China ARCHES Study of XTANDI^® Meets Primary Endpoint

XTANDI^® (enzalutamide) plus androgen deprivation therapy (ADT) significantly delays time to PSA progression compared to placebo plus ADT

TOKYO, MARCH 14, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline results from the Phase 3 China ARCHES study of XTANDI® (enzalutamide) plus androgen deprivation therapy...

Read more about Astellas Announces Phase 3 China ARCHES Study of XTANDI^® Meets Primary Endpoint
Mar 13, 2023

Results from Astellas’ Pivotal Phase 3 SKYLIGHT 1^TM Study of Fezolinetant for Vasomotor Symptoms Due to Menopause Published in The Lancet

Treatment with fezolinetant resulted in statistically significant reductions in the frequency and severity of VMS and improvements in quality of life

TOKYO, March 13, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced The Lancet published detailed results from the pivotal Phase 3 SKYLIGHT 1™ study of fezolinetant, an investigational oral, nonhormonal...

Read more about Results from Astellas’ Pivotal Phase 3 SKYLIGHT 1^TM Study of Fezolinetant for Vasomotor Symptoms Due to Menopause Published in The Lancet
Mar 9, 2023

Astellas and BMT CTN Announce Topline Results from Phase 3 MORPHO Trial of Gilteritinib

TOKYO and ROCKVILLE, Md., March 9, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) today announced topline results from the Phase 3 MORPHO clinical...

Read more about Astellas and BMT CTN Announce Topline Results from Phase 3 MORPHO Trial of Gilteritinib
Mar 9, 2023

Astellas and Seagen Announce China’s National Medical Products Administration Accepts Biologics License Application for Enfortumab Vedotin in Certain Patients with Locally Advanced or Metastatic Urothelial Cancer

– Clinical data submitted are consistent with global data and support enfortumab vedotin as a platinum-free option in patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy –

TOKYO and BOTHELL, Wash.– March 9, 2023 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq: SGEN) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products...

Read more about Astellas and Seagen Announce China’s National Medical Products Administration Accepts Biologics License Application for Enfortumab Vedotin in Certain Patients with Locally Advanced or Metastatic Urothelial Cancer
Mar 1, 2023

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, 2023 – 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...

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Feb 22, 2023

Announcement of Winning the 5th Japan Open Innovation Prize "Minister of Environment Award"

February 22, 2023 - Astellas Pharma Inc. (Headquarters: Tokyo; President and CEO: Kenji Yasukawa), The Mitsubishi Chemical Group, and CKD Corporation (Headquarters: Komaki, Aichi; President: Katsuhito Okuoka) won the Minister of Environment Award...

Read more about Announcement of Winning the 5th Japan Open Innovation Prize "Minister of Environment Award"
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...

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

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