News

- Expanded indication provides an approved perioperative treatment option for adult patients with resectable MIBC in the European Union - - Approval is based on Phase 3 EV-304 results...

TOKYO, October 8, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the company has ranked first in the pharmaceuticals sector for...

– PADCEV™ (enfortumab vedotin) plus pembrolizumab data highlight durable survival benefit in advanced bladder cancer – – VYLOY™ (zolbetuximab) research reinforces the role of CLDN18.2 in...

- Study evaluates novel, investigational KRAS G12D-targeted protein degrader setidegrasib versus docetaxel in previously treated patients with advanced NSCLC - - Milestone marks second Phase 3...

- Opinion based on data from pivotal Phase 3 EV-304 trial, which showed a 47% reduction in the risk of tumor recurrence, progression or death and a 35% reduction in the risk of death for the...

TOKYO, September 17, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the following personnel change in its Top Management, effective...

– 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...