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

Month Year

Sep 24, 2024

Astellas Receives Approval from the European Commission for VYLOY^TM (zolbetuximab) in Combination with Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer

- Zolbetuximab is currently the first and only therapy approved in the European Union to target claudin 18.2, a biomarker positively expressed by 38% of patients with advanced gastric cancer1,2 -

TOKYO, 20 September, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the European Commission (EC) has approved VYLOYTM (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients...

Read more about Astellas Receives Approval from the European Commission for VYLOY^TM (zolbetuximab) in Combination with Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer
Sep 24, 2024

Japan’s Ministry of Health, Labour and Welfare Approves PADCEV^TM(enfortumab vedotin) with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Radically Unresectable Urothelial Carcinoma

- Approval based on the EV-302 trial where the treatment combination nearly doubled median overall survival and significantly extended progression free survival compared to platinum-containing chemotherapy, the current standard of care for first-line treatment of radically unresectable urothelial carcinoma1 -

TOKYO, September 24, 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 approved PADCEVTM (enfortumab vedotin [genetical recombination]) with...

Read more about Japan’s Ministry of Health, Labour and Welfare Approves PADCEV^TM(enfortumab vedotin) with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Radically Unresectable Urothelial Carcinoma
Sep 18, 2024

Astellas Announces FDA Listing of DIGITIVA^TM for the Management of Heart Failure

- New digital health solution for heart failure management puts patients at the center of their care by providing ability for at-home disease monitoring -

TOKYO, September 18, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that DIGITIVA™, a non-invasive digital health solution for heart failure management, has been listed with...

Read more about Astellas Announces FDA Listing of DIGITIVA^TM for the Management of Heart Failure
Sep 11, 2024

Astellas Presents Scientific Progress in Advanced and Hard-to-Treat Cancers at ESMO 2024

- Eight abstracts, including two oral presentations, feature new clinical data from Astellas’ oncology portfolio and two lead pipeline programs across a broad range of cancer types -

TOKYO, September 11, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) will highlight new data from across its approved and investigational cancer therapies during the 2024 European Society...

Read more about Astellas Presents Scientific Progress in Advanced and Hard-to-Treat Cancers at ESMO 2024
Sep 4, 2024

Astellas to Present VEOZAH^TM (fezolinetant) Data at 2024 Annual Meeting of The Menopause Society

- Pooled analyses from two SKYLIGHT™ studies highlight impact on sleep disturbance and impairment, relationship between improvements in the frequency or severity of hot flashes and mood -

TOKYO, September 4, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) announced that VEOZAH™ (fezolinetant), its first-in-class treatment for moderate to severe vasomotor symptoms...

Read more about Astellas to Present VEOZAH^TM (fezolinetant) Data at 2024 Annual Meeting of The Menopause Society
Sep 3, 2024

Notice Regarding Issuance of Unsecured Bonds

TOKYO, September 3, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) successfully priced a dual-tranche of series 5th and 6th JPY denominated unsecured bonds (”the Bonds”) as below. The issuance of the Bonds is intended...

Read more about Notice Regarding Issuance of Unsecured Bonds
Aug 28, 2024

European Commission Approves Astellas’ PADCEV^TM (enfortumab vedotin) in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Urothelial Cancer

- First regimen approved in advanced urothelial cancer to demonstrate superiority to platinum-containing chemotherapy, the standard of care for nearly 40 years1 -

TOKYO, August 28, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the European Commission has granted Marketing Authorization for PADCEV™ (enfortumab vedotin, an antibody-drug conjugate [ADC])...

Read more about European Commission Approves Astellas’ PADCEV^TM (enfortumab vedotin) in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Urothelial Cancer
Aug 27, 2024

Astellas Initiates Phase 3 Clinical Study of Fezolinetant for VMS in Women with Breast Cancer Receiving Adjuvant Endocrine Therapy

- HIGHLIGHT 1™ study to evaluate fezolinetant for treatment of moderate to severe vasomotor symptoms in women with stage 0-3 hormone receptor positive breast cancer receiving adjuvant endocrine therapy -

TOKYO, August 27, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced dosing of the first patient in the HIGHLIGHT 1™ Phase 3 pivotal study for fezolinetant, an investigational...

Read more about Astellas Initiates Phase 3 Clinical Study of Fezolinetant for VMS in Women with Breast Cancer Receiving Adjuvant Endocrine Therapy
Aug 20, 2024

China’s National Medical Products Administration (NMPA) Approves PADCEV^TM (enfortumab vedotin) for Treatment of Locally Advanced or Metastatic Urothelial Cancer

- Approval based on the global EV-301 and China EV-203 trials, where enfortumab vedotin signficantly improved overall survival (OS) and objective response rate (ORR) respectively in patients following prior treatment with platinum-based chemotherapy and PD-1/L1 inhibitors1,2

TOKYO, August 20, 2024 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has...

Read more about China’s National Medical Products Administration (NMPA) Approves PADCEV^TM (enfortumab vedotin) for Treatment of Locally Advanced or Metastatic Urothelial Cancer
Aug 1, 2024

Notice Regarding Change in fair value of contingent consideration

TOKYO, August 1, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it booked ¥5.5 billion in the first quarter of fiscal year 2024 for change in the fair value of contingent...

Read more about Notice Regarding Change in fair value of contingent consideration
Jul 29, 2024

Astellas Receives Positive CHMP Opinion for PADCEV^TM (enfortumab vedotin) in combination with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

- If approved, enfortumab vedotin in combination with pembrolizumab will be the first and only treatment to offer an alternative to platinum-containing chemotherapy, the current standard of care for those with unresectable or metastatic urothelial cancer

TOKYO, July 26, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency...

Read more about Astellas Receives Positive CHMP Opinion for PADCEV^TM (enfortumab vedotin) in combination with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer
Jul 26, 2024

Astellas Receives Positive CHMP Opinion for Zolbetuximab in Combination with Chemotherapy for Treatment of Advanced Gastric and Gastroesophageal Junction Cancer

- If approved by the European Commission, zolbetuximab would become the first and only CLDN18.2-targeted therapy approved in the European Union

TOKYO, July 26, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that on July 26, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European...

Read more about Astellas Receives Positive CHMP Opinion for Zolbetuximab in Combination with Chemotherapy for Treatment of Advanced Gastric and Gastroesophageal Junction Cancer
Jul 22, 2024

Astellas and Graduate School of Medicine / Faculty of Medicine, Osaka University Enter into Research Collaboration to Develop Pluripotent Stem Cell-Derived Cartilage Organoid Cell Therapy

- Collaborative Research on Innovative Cartilage Organoid Cell Therapy for Intervertebral Disc Degenerative Disease using Astellas’ Universal Donor Cell Technology -

TOKYO and Osaka, July 22, 2024 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Graduate School of Medicine / Faculty of Medicine, Osaka University (President: Shojiro Nishio “Osaka University”) today announced...

Read more about Astellas and Graduate School of Medicine / Faculty of Medicine, Osaka University Enter into Research Collaboration to Develop Pluripotent Stem Cell-Derived Cartilage Organoid Cell Therapy
Jul 2, 2024

China’s National Medical Products Administration Approves XTANDI^® (enzalutamide) in Metastatic Hormone-Sensitive Prostate Cancer

- Approval marks XTANDI’s third indication for advanced prostate cancer in China -

TOKYO, July 2, 2024 – 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 approved...

Read more about China’s National Medical Products Administration Approves XTANDI^® (enzalutamide) in Metastatic Hormone-Sensitive Prostate Cancer
May 30, 2024

U.S. FDA ACKNOWLEDGES ASTELLAS’ RESUBMISSION OF BIOLOGICS LICENSE APPLICATION FOR ZOLBETUXIMAB AND SETS NEW ACTION DATE

If approved, the investigational therapy would offer a new treatment option for patients with advanced gastric and gastroesophageal junction cancers as the first and only CLDN18.2-targeted therapy in the U.S.

TOKYO, May 30, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the company’s resubmission of the Biologics License Application (BLA) for zolbetuximab...

Read more about U.S. FDA ACKNOWLEDGES ASTELLAS’ RESUBMISSION OF BIOLOGICS LICENSE APPLICATION FOR ZOLBETUXIMAB AND SETS NEW ACTION DATE
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...

Read more about Notice Regarding Continuation of the Performance-linked Stock Compensation Scheme
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...

Read more about Change in Definition of Core Basis in Financial Results
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

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