News

– Agreement supports commitment to patient access, affordability and innovation – TOKYO, August 31, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”)...

- Partnership supports the development of next-generation leaders contributing to a more sustainable society - - Summit scheduled to take place at the Tokyo International Forum from September 28...

- ASP2138's advancement into Phase 3 marks an important milestone in Astellas' commitment to advancing research in CLDN18.2 with its differentiated portfolio, spanning approved treatments and...

TOKYO, August 7, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) confirms it has submitted a New Drug Application (NDA) to Japan's Ministry of Health,...

View Q1/FY2026 Financial results and related materials.

- First and only treatment regimen for adults with MIBC, regardless of cisplatin eligibility, representing a platinum-free potential standard of care - - Broadened approval supported by Phase 3...

TOKYO, July 7, 2026 – 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...

- Approval based on Phase 3 EV-303 results demonstrating significant improvements in event-free survival and overall survival compared with surgery alone - - Despite curative-intent surgery,...

TOKYO, May 29, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, the “Company”) hereby announces that Dr. Andreas Busch, an Outside Director of the Company, has...

TOKYO, May 29, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, the “Company”) has noted that Institutional Shareholder Services Inc. (“ISS”), a proxy advisory...

- Company sets ambition to achieve pipeline-led, record-high revenues by the mid-2030s - - CSP2026 is a growth strategy that will deliver profitable growth and generate cash, accelerate...

- Positive opinion is based on data from the pivotal Phase 3 EV-303 trial showing a 60% reduction in the risk of disease recurrence, progression or death and a 50% reduction in the risk of death...

- 10 abstracts, including two oral presentations, reinforce Astellas’ long-term commitment to advancing oncology care - TOKYO, May 18, 2026 – Astellas Pharma Inc. (TSE: 4503, President and...

TOKYO, May 15, 2026 – 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...

TOKYO, May 15, 2026– 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...

- Avacincaptad pegol granted Priority Review status in China - TOKYO, May 15, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the...

TOKYO, May 14, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the submission of a Supplemental New Drug Application (sNDA) to Japan's...

Pooled post hoc analysis of GATHER1 and GATHER2 showed IZERVAY® (avacincaptad pegol intravitreal solution) reduced the risk of progressing to loss of driving eligibility compared with sham over...

View Financial Results of Astellas for FY2025.

TOKYO, April 27, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it booked an impairment loss for intangible assets and recorded...

TOKYO, April 27, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the following personnel change in its Top Management, effective from...

TOKYO, April 27, 2026 – 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...

TOKYO, April 24, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that MSN Pharmaceuticals, Inc. and MSN Laboratories Private Ltd....

- Submission based on statistically significant event-free and overall survival data from the Phase 3 EV-304 trial - - Building on the existing indication in cisplatin-ineligible muscle-invasive...

- Setidegrasib is an investigational, novel KRAS G12D-targeted protein degrader - - KRAS G12D mutations occur in approximately 40% of pancreatic ductal adenocarcinomas, with no approved targeted...

TOKYO, March 31, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the following changes to its Top Management, effective April 1, 2026.

TOKYO, March 23, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the European Medicines Agency (EMA) has validated for review a...

TOKYO AND ROTTERDAM, March 9, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and HOVON Foundation (Rotterdam, The Netherlands) today announced that the...

In the Phase 3 EV-304 trial, statistically significant improvements in overall survival and pathological complete response were also observed, with over half of patients having no detectable...

- Astellas and Vir Biotechnology to co-develop and co-commercialize VIR-5500 through a sharing of expenses and revenues - - Astellas to lead commercialization of VIR-5500 in the U.S. with Vir...

TOKYO, February 12, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it has reached separate agreements with Lupin Limited and Lupin...

TOKYO, February 10, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it has reached an agreement with Lupin Limited and Lupin...

TOKYO, February 4, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced upward revisions to its consolidated financial forecast for the...

View Financial Results of Astellas for Q3 YTD/FY2025.

TOKYO, February 3, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced topline results from the STARLIGHT™ 2 Phase 3 pivotal study for...

- Data from the Phase 3 EV-303 trial found that enfortumab vedotin plus pembrolizumab showed a 60% reduction in the risk of disease recurrence, progression or death, and a 50% reduction in the...

TOKYO, January 7, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced it will present at the 44th Annual J.P. Morgan Healthcare Conference,...

- Pioneering cell therapy innovation through robotics and AI - - Among the first innovator pharmaceutical companies granted AMT designation - - Enabling early, priority engagement with FDA to...

PADCEV plus Keytruda is the first and only regimen without platinum-based chemotherapy to improve event-free and overall survival when used before and after surgery in cisplatin-eligible patients...

- Data reflect new insights and precision oncology advancements in portfolio and pipeline - - Cohort results from Phase 2 ILUSTRO study evaluating a zolbetuximab triplet combination regimen in...

- Presentations include pooled post-hoc analysis of the Phase 3 ADMIRAL and COMMODORE data on post-transplant gilteritinib resumption in relapsed or refractory FLT3m+ AML - - Findings from the...

TOKYO, November 28, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the European Medicines Agency (EMA) validated for review a Type...

- PADCEV plus Keytruda is the first and only approved perioperative treatment regimen that can significantly improve survival over current standard of care (surgery alone) in cisplatin-ineligible...

TOKYO, October 30, 2025 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced revisions to its consolidated financial forecast for the fiscal year...

View Financial Results of Astellas for Q2 YTD/FY2025.

Extensive and growing evidence continues to reinforce fezolinetant as an effective treatment for moderate to severe VMS associated with menopause Preliminary analysis from OPTION-VMS observational...

Results from the pivotal EV-303 trial demonstrated that, when used before and after surgery, the combination reduced the risk of recurrence, progression or death by 60% and the risk of death by...

In GATHER2 open-label extension study, IZERVAY reduced GA growth 37-40.5% vs. projected sham, with earlier intervention resulting in greater protection of retinal tissue area Study results found...

First and only combination regimen to improve survival when used before and after surgical cystectomy in cisplatin-ineligible patients with muscle-invasive bladder cancer Unprecedented survival...

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that VEOZAH™ (fezolinetant), its first-in-class, targeted, non-hormonal treatment for moderate to...