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

Month Year

Mar 6, 2025

Astellas and YASKAWA Agree to Establish a Joint Venture Focused on Cell Therapy Manufacturing

- Joint venture will aim to develop a cell therapy manufacturing platform through robotics and will offer access to startups and academic institutions -

TOKYO, March 6, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and YASKAWA Electric Corporation (TSE: 6506, President and CEO; Masahiro Ogawa, “YASKAWA”)...

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Feb 13, 2025

U.S. FDA Approves Expanded Label for Astellas’ IZERVAY^TM (avacincaptad pegol intravitreal solution) for Geographic Atrophy

- IZERVAY dosing approved beyond 12 months -

TOKYO, February 13, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the U.S. Food and Drug Administration (FDA) approved expanded U.S. Prescribing information for IZERVAY™...

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Feb 12, 2025

Pfizer and Astellas’ PADCEV^® (enfortumab vedotin-ejfv) plus KEYTRUDA^® (pembrolizumab) Shows Long-Term Efficacy in First Line Treatment of Locally Advanced or Metastatic Urothelial Cancer (la/mUC)

•Enfortumab vedotin plus pembrolizumab continues to demonstrate superior efficacy versus chemotherapy in a broad population, reinforcing the combination as standard of care in first-line treatment of la/muC

TOKYO and NEW YORK, February 12, 2025 – Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced additional follow-up results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39)...

Read more about Pfizer and Astellas’ PADCEV^® (enfortumab vedotin-ejfv) plus KEYTRUDA^® (pembrolizumab) Shows Long-Term Efficacy in First Line Treatment of Locally Advanced or Metastatic Urothelial Cancer (la/mUC)
Feb 5, 2025

Recording of Extraordinary Losses in Non-consolidated Financial Results(J-GAAP)

TOKYO, February 5, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it recorded extraordinary losses in the non-consolidated financial results as below....

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Feb 5, 2025

Astellas Submits New Drug Application for Conditional Approval of Avacincaptad Pegol for Geographic Atrophy in Japan

- Ministry of Health, Labour and Welfare to evaluate ACP as potential first and only treatment for patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in Japan -

TOKYO, February 5, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the submission of a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW)...

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Feb 4, 2025

Astellas Makes Announcement about Management Structure

TOKYO, February 4, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the following changes to its management structure effective April 1, 2025....

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Jan 24, 2025

Notice Regarding Progress in Core Business, Impairment Loss and Revision of Financial Forecasts for FY2024

TOKYO, January 24, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the financial forecast for fiscal year 2024 announced on October 30, 2024...

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Jan 9, 2025

U.S. FDA Confirms Class 1 Resubmission of the Supplemental New Drug Application for IZERVAY^TM (avacincaptad pegol intravitreal solution) for Geographic Atrophy

TOKYO, January 9, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the U.S. Food and Drug Administration (FDA) accepted the revised supplemental New Drug Application...

Read more about U.S. FDA Confirms Class 1 Resubmission of the Supplemental New Drug Application for IZERVAY^TM (avacincaptad pegol intravitreal solution) for Geographic Atrophy
Jan 8, 2025

China’s National Medical Products Administration (NMPA) Approves PADCEV^TM in combination with KEYTRUDA^® (pembrolizumab) for the Treatment of Advanced Bladder Cancer

- First regimen to be approved in China to demonstrate superiority to platinum-containing chemotherapy for the treatment of locally advanced or metastatic urothelial cancer, the standard of care for nearly 40 years1

TOKYO, January 8, 2025 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that China’s National Medical Products Administration (NMPA) has approved...

Read more about China’s National Medical Products Administration (NMPA) Approves PADCEV^TM in combination with KEYTRUDA^® (pembrolizumab) for the Treatment of Advanced Bladder Cancer
Jan 6, 2025

China’s National Medical Products Administration (NMPA) Approves VYLOY^TM (zolbetuximab) for First-Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

- China has the highest number of cases and deaths from gastric cancer of any country worldwide1 -

TOKYO, Jan. 06, 2025 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) today announced that China’s National Medical Products Administration (NMPA) has approved VYLOY™ (zolbetuximab)...

Read more about China’s National Medical Products Administration (NMPA) Approves VYLOY^TM (zolbetuximab) for First-Line Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Dec 19, 2024

Astellas and Sangamo Therapeutics Announce Capsid License Agreement to Deliver Genomic Medicines for Neurological Diseases

- Agreement grants Astellas rights to employ Sangamo’s novel proprietary capsid, STAC-BBB, for up to five potential neurological disease targets -

TOKYO and RICHMOND, California, December 19, 2024 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company...

Read more about Astellas and Sangamo Therapeutics Announce Capsid License Agreement to Deliver Genomic Medicines for Neurological Diseases
Nov 19, 2024

Astellas Provides Update on IZERVAY^TM (avacincaptad pegol intravitreal solution) Supplemental New Drug Application

TOKYO, Nov. 19, 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 (CRL) on November 15...

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Oct 30, 2024

Notice Regarding Foreign Exchange Loss

TOKYO, October 30, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it has booked a foreign exchange gain of ¥1.9 billion as other income for the first quarter ...

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Oct 28, 2024

Astellas Provides Update on Marketing Authorization Application for Avacincaptad Pegol (ACP) in the European Union

TOKYO, Oct 28, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the company's decision to withdraw its marketing authorization application from the European Medicines...

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Oct 21, 2024

Astellas’ VYLOY^TM (zolbetuximab-clzb) Approved by U.S. FDA for Treatment of Advanced Gastric and GEJ Cancer

- VYLOY is the first and only CLDN18.2-targeted treatment approved in the U.S. for adults with advanced gastric and gastroesophageal junction cancer whose tumors are CLDN18.2 positive -

TOKYO, Oct. 18, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY™ (zolbetuximab-clzb) in...

Read more about Astellas’ VYLOY^TM (zolbetuximab-clzb) Approved by U.S. FDA for Treatment of Advanced Gastric and GEJ Cancer
Oct 10, 2024

Astellas to Present VEOZA^TM (fezolinetant) Data at IMS World Congress on Menopause

TOKYO, October 10, 2024 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) announced that VEOZA™ (fezolinetant)*, its first-in-class treatment for moderate to severe vasomotor symptoms...

Read more about Astellas to Present VEOZA^TM (fezolinetant) Data at IMS World Congress on Menopause
Oct 8, 2024

Astellas and AviadoBio Announce Exclusive Option and License Agreement for Gene Therapy AVB-101 Targeting Frontotemporal Dementia and Other Indications

- Astellas receives an exclusive option to license AVB-101, an investigational, AAV-based gene therapy in Phase 1/2 development -

LONDON, and TOKYO, - Oct 8, 2024 – AviadoBio Ltd. (“AviadoBio”) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced an exclusive option and license agreement for AVB-101...

Read more about Astellas and AviadoBio Announce Exclusive Option and License Agreement for Gene Therapy AVB-101 Targeting Frontotemporal Dementia and Other Indications
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...

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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

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