Astellas Pharma Inc. (4503.T) — Upcoming Catalysts
FDA PDUFA dates, advisory-committee meetings, and Phase 2/3 readout windows for Astellas Pharma Inc., built from public data lanes (ClinicalTrials.gov and official sources). Each row links to its source.
For informational purposes only — not investment advice. Track 4503.T live on Mooboard →
Next 30 days1
- Aug 31, 2026ClinicalTrials.gov ↗Astellas Pharma Inc.(4503.T)Phase 2/3 readoutzolbetuximab · Phase 2 · Pancreatic Cancer; Metastatic Pancreatic CancerNCT03816163: A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer. Primary completion 2026-08-31 (estimated); status ACTIVE_NOT_RECRUITING.
Later15
- Dec 31, 2026ClinicalTrials.gov ↗Astellas Pharma Inc.(4503.T)Phase 2/3 readoutzolbetuximab · Phase 2 · Pharmacokinetics of Zolbetuximab; Gastric CancerNCT03505320: A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer. Primary completion 2026-12-31 (estimated); status ACTIVE_NOT_RECRUITING.
- Mar 31, 2027ClinicalTrials.gov ↗Astellas Pharma Inc.(4503.T)Phase 2/3 readoutzolbetuximab · Phase 3 · Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer; Locally Advanced Unresectable Gastric Adenocarcinoma or CancerNCT06901531: A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer. Primary completion 2027-03-31 (estimated); status RECRUITING.
- Oct 30, 2027ClinicalTrials.gov ↗Astellas Pharma Inc.(4503.T)Phase 2/3 readoutRoxadustat · Phase 3 · Chronic Kidney Disease; Renal AnemiaNCT05970172: A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease. Primary completion 2027-10-30 (estimated); status RECRUITING.
- Nov 30, 2027ClinicalTrials.gov ↗Astellas Pharma Inc.(4503.T)Phase 2/3 readoutEnfortumab Vedotin · Phase 2 · Muscle-invasive Bladder CancerNCT07475806: A Study to Find Out if Enfortumab Vedotin Given With Pembrolizumab Helps People With Muscle-invasive Bladder Cancer Keep Their Bladder. Primary completion 2027-11-30 (estimated); status RECRUITING.
- Jul 31, 2028ClinicalTrials.gov ↗Astellas Pharma Inc.(4503.T)Phase 2/3 readoutGilteritinib · Phase 1 / Phase 2 · Acute Myeloid Leukemia (AML); FLT3-mutated Acute Myeloid LeukemiaNCT05520567: A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia. Primary completion 2028-07-31 (estimated); status ACTIVE_NOT_RECRUITING.
- Jun 30, 2029ClinicalTrials.gov ↗Astellas Pharma Inc.(4503.T)Phase 2/3 readoutASP2998 · Phase 1 / Phase 2 · Locally Advanced or Metastatic Malignant Solid TumorsNCT07287995: A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors. Primary completion 2029-06-30 (estimated); status RECRUITING.
- Jul 31, 2029ClinicalTrials.gov ↗Astellas Pharma Inc.(4503.T)Phase 2/3 readoutenzalutamide · Phase 2 · Prostate CancerNCT02960022: A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study. Primary completion 2029-07-31 (estimated); status RECRUITING.
- Jul 31, 2029ClinicalTrials.gov ↗Astellas Pharma Inc.(4503.T)Phase 2/3 readoutASP546C · Phase 1 / Phase 2 · Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma; Pancreatic AdenocarcinomaNCT07488676: A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors. Primary completion 2029-07-31 (estimated); status RECRUITING.
- Aug 31, 2029ClinicalTrials.gov ↗Astellas Pharma Inc.(4503.T)Phase 2/3 readoutSetidegrasib · Phase 3 · Pancreatic Cancer; Metastatic Pancreatic CancerNCT07409272: A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer. Primary completion 2029-08-31 (estimated); status RECRUITING.
- Feb 28, 2030ClinicalTrials.gov ↗Astellas Pharma Inc.(4503.T)Phase 2/3 readoutASP2246 · Phase 1 / Phase 2 · Chronic Ischemic StrokeNCT07318714: A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke. Primary completion 2030-02-28 (estimated); status RECRUITING.
- Feb 28, 2030ClinicalTrials.gov ↗Astellas Pharma Inc.(4503.T)Phase 2/3 readoutASP388B · Phase 1 / Phase 2 · Locally Advanced or Metastatic Solid TumorsNCT07730021: A Study of ASP388B Given by Itself and With Standard Therapies in Participants With Solid Tumors. Primary completion 2030-02-28 (estimated); status NOT_YET_RECRUITING.
- Mar 31, 2030ClinicalTrials.gov ↗Astellas Pharma Inc.(4503.T)Phase 2/3 readoutEnfortumab vedotin · Phase 3 · Urothelial Cancer; Urinary Bladder NeoplasmsNCT07566156: Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309). Primary completion 2030-03-31 (estimated); status RECRUITING.
- Jun 30, 2030ClinicalTrials.gov ↗Astellas Pharma Inc.(4503.T)Phase 2/3 readoutSetidegrasib · Phase 3 · Non-small Cell Lung Cancer (NSCLC)NCT07566052: A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation. Primary completion 2030-06-30 (estimated); status RECRUITING.
- Feb 28, 2031ClinicalTrials.gov ↗Astellas Pharma Inc.(4503.T)Phase 2/3 readoutASP2138 · Phase 3 · Gastric Adenocarcinoma; Gastroesophageal Junction (GEJ) AdenocarcinomaNCT07673887: A Study of ASP2138 Together With Chemotherapy and Pembrolizumab in Adults With Gastric Cancer. Primary completion 2031-02-28 (estimated); status RECRUITING.
- May 31, 2032ClinicalTrials.gov ↗Astellas Pharma Inc.(4503.T)Phase 2/3 readoutASP5541 · Phase 2 · Prostate Cancer; Metastatic Castration-Resistant Prostate CancerNCT07005154: A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer. Primary completion 2032-05-31 (estimated); status RECRUITING.
How Astellas Pharma Inc. has moved — past-year price reactions
How binary is 4503.T? Its typical daily move, how often it swings ±10%, and its biggest single-day moves over the last year — useful context for sizing around a catalyst.
1%
typical day (1Y)
0
±10% days
29.3%
annualized vol
242
trading days
Largest single-day moves
- +7.7%2026-02-05no matched headline
- +7.5%2026-05-29no matched headline
- +6%2026-08-06no matched headline
- +5.6%2025-11-04no matched headline
- +5.5%2026-04-01no matched headline
- +5.3%2026-03-24no matched headline
Real daily price moves over the past year — not every move is a catalyst, and headlines (where shown) are a possible same-day driver, not confirmed causation.
Astellas Pharma Inc. — active clinical pipeline
Astellas Pharma Inc.'s registered Phase 1–3 programs by asset and indication, derived from ClinicalTrials.gov.
19 assets33 programsPh1 11Ph2 11Ph3 9· 2 post-marketing (Ph4)
AreasOncologyImmunologyCardiovascularOther
AssetPhase 1Phase 2Phase 3
SetidegrasibOncology
Phase 1
zolbetuximabOncology · CLDN18
ASP2138Oncology
Phase 3
Enfortumab vedotinOncology · Nectin-4 ADC
Phase 3
GilteritinibOncology · AXL/FLT3
Phase 2
Phase 3
FezolinetantOther · TACR3
Phase 3
mirabegronOther · ADRB3
RoxadustatOther · EGLN2
Phase 3
ASP2246Cardiovascular
Phase 2
ASP2998Oncology
ASP388BOncology
ASP546COncology
enzalutamideOncology · AR
Phase 2
ASP1002Oncology
Phase 1
ASP2390Immunology
Phase 1
ASP5834Oncology
Phase 1
PRL-02 injectionOncology
Phase 1
Active registered Phase 1–3 trials from ClinicalTrials.gov — not the company's official IR pipeline (no preclinical or undisclosed assets). Grouped by trial intervention name; therapeutic area is auto-categorized. Each indication links to its trial. Molecular targets sourced from ChEMBL (EMBL-EBI).
See the full biopharma catalyst calendar across all covered companies.