Astellas Pharma

Astellas is a Tokyo-based drugmaker that sells cancer, eye, urology and women's health medicines, led by XTANDI for prostate cancer and PADCEV for bladder cancer.

The world Astellas works in, not its own labs. Credits in the footer.

Ticker: 4503
Listing: TSE, Japan
Next date: Q3 FY2026 (October to December 2026)
Chief executive: Naoki Okamura (Representative Director, President and CEO)

Desk view · Opinion · Updated Oct 22, 2026

Astellas is outrunning XTANDI's expected decline, for now

Astellas is a profitable company in a planned handover from XTANDI to PADCEV and four other newer brands, with PADCEV, the largest of the newer brands, winning a string of bladder cancer approvals. The longer case rests on degrader and CLDN18.2 programs that have only just entered phase 3. Near-term results will turn on launches, costs and currency.

Read the full desk view

aibio.space Investor Rank · Opinion

8/10 Positive view

Profitable, with PADCEV and newer brands offsetting the planned XTANDI decline; the pipeline meant to take over later has only just entered phase 3.

Technology: 2/2
Odds: 1/2
Balance sheet: 2/2
Risk: 1/2
Momentum: 2/2

Opinion only. The Investor Rank is aibio.space's opinion of the company's business position, drawn from the public sources on this page. It is not a recommendation to buy, sell or hold any security and it is not investment advice. It does not consider the share price, valuation or your circumstances, and it can change at any time. Payments from companies never affect it. How the rank works.

Technology: Proven commercial portfolio. PADCEV cut recurrence, progression or death 47% against chemotherapy in operable bladder cancer, and the newer pipeline leans on protein degraders and CLDN18.2 drugs.
Odds: Mixed by stage. Marketed brands are de-risked, but setidegrasib and ASP2138 are fresh phase 3 programs with oncology odds of 47.7% from phase 3 to filing and 43.9% from phase 3 to approval, per BIO 2011 to 2020 data.
Balance sheet: Profitable and paying out. Q1 revenue was 640.9 billion yen with 244.7 billion yen of cash against 589.9 billion yen of debt, and the dividend is rising.
Main risk: XTANDI erosion. The forecast assumes XTANDI sales drop about 50 billion yen this year, and newer brands must fill the gap as U.S. pricing terms tighten.
Watch next: Japan PADCEV decision. A Japanese ruling in cisplatin-ineligible bladder cancer is expected by December 2026, and the next quarterly report will test the forecast.

Dates

Q3 FY2026 (October to December 2026)
Japanese regulatory decision on PADCEV plus Keytruda in cisplatin-ineligible MIBC Source

FY2027
Phase 3 LUCERNA readout for VYLOY with pembrolizumab and chemotherapy in gastric cancer Source

FY2027
Target of five or more phase 3 or registrational study starts under CSP2026 Source

Estimated June 2030
Primary completion of the setidegrasib phase 3 lung cancer trial Source

The money

Cash and cash equivalents of 244.7 billion yen at June 30, 2026 (Q1 FY2026), down 36.9 billion yen in the quarter; bonds and borrowings of 589.9 billion yen. Astellas is profitable and gives earnings guidance rather than runway guidance. Source

Revenue of 640.9 billion yen in Q1 FY2026 (April to June 2026), up 26.7%; XTANDI 276.6 billion yen, PADCEV 75.5 billion yen. FY2026 forecast: 2,220.0 billion yen. Source

Risks on the record

XTANDI, still the largest product, is expected to lose about 50 billion yen of revenue in FY2026 as it heads toward loss of exclusivity. Source
Under its August 2026 U.S. agreement, Astellas will lower Medicaid prices and align future launch prices with other developed nations; not all terms are disclosed. Source
Late-stage trials can fail: a phase 3 study of gilteritinib in newly diagnosed FLT3-mutated AML missed its overall survival endpoint in March 2026. Source

Questions investors ask

What is aibio.space's Investor Rank for Astellas Pharma?

8 out of 10, our positive view. Profitable, with PADCEV and newer brands offsetting the planned XTANDI decline; the pipeline meant to take over later has only just entered phase 3. This is opinion only, not a recommendation to buy, sell or hold, and it does not consider the share price or valuation. Source

Who is the CEO of Astellas Pharma?

Naoki Okamura is Representative Director, President and CEO of Astellas. The company's September 2026 top management list, effective October 1, names him in that role. Source

What is Astellas' best-selling drug?

XTANDI, for prostate cancer, sold 276.6 billion yen in the April to June 2026 quarter. That was more than the 160.3 billion yen from all five Strategic Brands combined. Source

What did the EU approve for Padcev in October 2026?

The European Commission approved PADCEV with Keytruda before and after surgery for adults with resectable muscle-invasive bladder cancer regardless of cisplatin eligibility. The decision was based on the EV-304 trial, where the combination cut the risk of recurrence, progression or death by 47% against chemotherapy. Source

What is setidegrasib?

Setidegrasib is an Astellas-discovered protein degrader that targets the KRAS G12D mutation. It is in phase 3 in first-line pancreatic cancer and in previously treated non-small cell lung cancer. Source

What are Astellas' financial targets to 2030?

Under CSP2026, Astellas aims to start 10 or more phase 3 or registrational studies by FY2030, double Strategic Brands revenue from FY2025, generate more than 4.3 trillion yen of cumulative core operating profit before R&D and raise the dividend by at least 2 yen a year. It targets a 30% core operating margin by FY2027. Source

Legal and investor matters

Checked against Astellas Pharma filings and press releases. Allegations are allegations; nothing here is a finding of fault. Reviewed Oct 25, 2026.

Note 34 of the consolidated financial statements for the year ended 2026-03-31 says the Group is involved in various claims and legal proceedings of a nature considered common to the pharmaceutical industry, generally related to product liability, competition and antitrust law, intellectual property, employment claims and government investigations, and that there were no material contingent liabilities required to be disclosed as at the date of submission. It does not name specific cases. Source

Apr 27, 2026Litigation
Astellas records yen 9.2 billion in other income for Myrbetriq litigation settlements in the U.S.
Astellas' results for the fiscal year ended March 31, 2026, released April 27, 2026, record a settlement payment for Myrbetriq litigation of 9.2 billion yen under other income. The financial statements attribute the line to Mirabegron litigation settlements in the United States. The documents do not name the counterparties, courts or case numbers. Note 34 of the statements reports no material contingent liabilities.
Status: settled
Astellas FY2025 financial results, 2026-04-27
Apr 27, 2026Financing
Astellas repays yen 267.4 billion of bonds and borrowings in fiscal 2025
Astellas reported on April 27, 2026 that net cash flows from bonds and borrowings were an outflow of 267.4 billion yen in the fiscal year ended March 31, 2026. Total bonds and borrowings fell from 831.4 billion yen to 566.0 billion yen. Long-term borrowings fell from 244.9 billion yen to 100.0 billion yen. Net cash flows from financing activities were an outflow of 404.8 billion yen.
Astellas FY2025 financial results, 2026-04-27

Pipeline

Program	Indication	Stage
PADCEV (enfortumab vedotin) plus Keytruda	Resectable muscle-invasive bladder cancer	Approved in the U.S. (July 2026) and EU (October 2026) regardless of cisplatin eligibility; filed in Japan Source
Setidegrasib (ASP3082)	KRAS G12D-mutated metastatic pancreatic cancer (first line) and previously treated non-small cell lung cancer	Phase 3 (two studies) Source
ASP2138	CLDN18.2-positive, HER2-negative gastric or GEJ adenocarcinoma, first line	Phase 3 Source
VYLOY (zolbetuximab) plus pembrolizumab and chemotherapy	Gastric and GEJ cancer	Phase 3 LUCERNA, enrollment completed July 2026 Source
IZERVAY (avacincaptad pegol)	Geographic atrophy secondary to AMD	Marketed; NDA accepted in China with priority review (May 2026) Source
Fezolinetant	Menopause vasomotor symptoms (Japan)	NDA submitted in Japan (August 2026) Source

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