Daiichi Sankyo Company, Limited (4568.T) — Upcoming Catalysts

FDA PDUFA dates, advisory-committee meetings, and Phase 2/3 readout windows for Daiichi Sankyo Company, Limited, built from public data lanes (ClinicalTrials.gov and official sources). Each row links to its source.

For informational purposes only — not investment advice. Track 4568.T live on Mooboard →

This week1

  • Sep 30, 2026
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    Ifinatamab deruxtecan · Phase 1 / Phase 2 · Extensive Stage-small Cell Lung Cancer
    NCT06362252: A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03). Primary completion 2026-09-30 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗

Next 30 days1

  • Oct 20, 2026
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    DS-3939a · Phase 1 / Phase 2 · Advanced Solid Tumor; Metastatic Solid Tumor
    NCT05875168: First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors. Primary completion 2026-10-20 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗

Later23

  • Jan 31, 2027
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    DS-5141b · Phase 2 · Duchenne Muscular Dystrophy
    NCT04433234: Long-term, Extension Study of DS-5141b in Patients With Duchenne Muscular Dystrophy. Primary completion 2027-01-31 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗
  • Apr 30, 2027
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    Ifinatamab deruxtecan (I-DXd) · Phase 1 / Phase 2 · Advanced Solid Tumor; Malignant Solid Tumor
    NCT04145622: Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors. Primary completion 2027-04-30 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • May 1, 2027
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    Quizartinib · Phase 1 / Phase 2 · Acute Myeloid Leukemia
    NCT03793478: Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood. Primary completion 2027-05-01 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗
  • Sep 1, 2027
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    HER3-DXd · Phase 2 · Advanced Solid Tumor; Melanoma
    NCT06172478: A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors. Primary completion 2027-09-01 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Sep 30, 2027
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    Raludotatug deruxtecan · Phase 2 · Advanced Solid Tumor; Metastatic Solid Tumors
    NCT06660654: A Study of Raludotatug Deruxtecan in Participants With Advanced/Metastatic Solid Tumors (REJOICE-PanTumor01). Primary completion 2027-09-30 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗
  • Oct 1, 2027
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    Trastuzumab Deruxtecan · Phase 3 · Breast Cancer
    NCT05950945: Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer. Primary completion 2027-10-01 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Jan 30, 2028
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    Ifinatamab deruxtecan · Phase 3 · Small Cell Lung Cancer
    NCT06203210: A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer. Primary completion 2028-01-30 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Feb 29, 2028
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    R-DXd · Phase 2 / Phase 3 · Solid Cancer
    NCT06161025: A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer. Primary completion 2028-02-29 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Mar 30, 2028
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    valemetostat tosylate · Phase 1 / Phase 2 · Non-small Cell Lung Cancer; Lung Cancer
    NCT06644768: A Study of Valemetostat Tosylate Plus Pembrolizumab Versus Pembrolizumab Alone in First-Line NSCLC Without Actionable Genomic Alterations. Primary completion 2028-03-30 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗
  • Jun 1, 2028
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    Bempedoic acid · Phase 3 · Coronary Atherosclerosis; Mixed Dyslipidemia
    NCT07474649: A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events. Primary completion 2028-06-01 (estimated); status NOT_YET_RECRUITING.
    ClinicalTrials.gov ↗
  • Jun 1, 2028
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    Trastuzumab Deruxtecan · Phase 3 · Gastric Cancer; Gastroesophageal Junction Cancer
    NCT06731478: Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer. Primary completion 2028-06-01 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Jun 1, 2028
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    Ifinatamab deruxtecan · Phase 3 · Esophageal Squamous Cell Carcinoma
    NCT06644781: A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01). Primary completion 2028-06-01 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Jun 6, 2028
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    Quizartinib High Dose · Phase 2 · Acute Myeloid Leukemia; Leukemia
    NCT06824168: Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission. Primary completion 2028-06-06 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Jul 25, 2028
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    Ifinatamab deruxtecan · Phase 1 / Phase 2 · Recurrent or Metastatic Solid Tumors
    NCT06330064: A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02). Primary completion 2028-07-25 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Nov 1, 2028
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    Trastuzumab Deruxtecan · Phase 3 · Ovarian Cancer
    NCT06819007: Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01). Primary completion 2028-11-01 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • May 11, 2029
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    Datopotamab Deruxtecan · Phase 3 · Metastatic Non Small Cell Lung Cancer
    NCT05555732: Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07). Primary completion 2029-05-11 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗
  • Jun 1, 2029
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    Dato-DXd · Phase 2 / Phase 3 · Urothelial Cancer; Bladder Cancer
    NCT07129993: Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma. Primary completion 2029-06-01 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Jul 1, 2029
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    R-DXd · Phase 3 · Fallopian Tube Cancer; Primary Peritoneal Cancer
    NCT07791732: A Study of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab as Maintenance Therapy in Second-Line Platinum-Sensitive Recurrent Ovarian Cancer (REJOICE-Ovarian03). Primary completion 2029-07-01 (estimated); status NOT_YET_RECRUITING.
    ClinicalTrials.gov ↗
  • Mar 4, 2030
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    Datopotamab Deruxtecan · Phase 3 · Metastatic Non Small Cell Lung Cancer
    NCT05215340: Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations. Primary completion 2030-03-04 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗
  • Apr 24, 2030
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    Trastuzumab Deruxtecan · Phase 3 · Non-small Cell Lung Cancer
    NCT06899126: Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer. Primary completion 2030-04-24 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Jun 26, 2030
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    Quizartinib · Phase 3 · Leukemia
    NCT06578247: Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML. Primary completion 2030-06-26 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗
  • Jul 4, 2030
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    Trastuzumab deruxtecan · Phase 3 · Advanced Breast Cancer; Metastatic Breast Cancer
    NCT07683754: T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd. Primary completion 2030-07-04 (estimated); status NOT_YET_RECRUITING.
    ClinicalTrials.gov ↗
  • Jul 31, 2030
    Daiichi Sankyo Company, Limited(4568.T)Phase 2/3 readout
    DS-3939a · Phase 1 / Phase 2 · Solid Tumor; Locally Advanced Non-Small Cell Lung Cancer
    NCT07739966: A Study of DS-3939a in Participants With Solid Tumors. Primary completion 2030-07-31 (estimated); status NOT_YET_RECRUITING.
    ClinicalTrials.gov ↗

How Daiichi Sankyo Company, Limited has moved — past-year price reactions

How binary is 4568.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.

1.5%
typical day (1Y)
2
±10% days
38.5%
annualized vol
242
trading days
Largest single-day moves
  • -11.1%2026-07-31no matched headline
  • -10.4%2026-04-24no matched headline
  • -8.1%2025-11-04no matched headline
  • +7.7%2025-10-02no matched headline
  • -6.1%2026-06-19no matched headline
  • +5.9%2026-03-17no 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.

Daiichi Sankyo Company, Limited — active clinical pipeline

Daiichi Sankyo Company, Limited's registered Phase 1–3 programs by asset and indication, derived from ClinicalTrials.gov.

36 assets57 programsPh1 18Ph2 17Ph3 22
AreasOncologyCardiovascularRare / GeneticOther
Trastuzumab DeruxtecanOncology · HER2 ADC
Phase 1
Recurrent or Metastatic Solid Tumors
Phase 3
Advanced Breast CancerBreast CancerEndometrial CancerGastric CancerGastric Cancer, AdenocarcinomaNon-small Cell Lung CancerOvarian Cancer
Ifinatamab deruxtecanOncology
Phase 2
Extensive Stage-small Cell Lung CancerRecurrent or Metastatic Solid Tumors
Phase 3
Esophageal Squamous Cell CarcinomaSmall Cell Lung Cancer
QuizartinibOncology · CSF1R/FLT3/KIT/PDGFRβ/RET
Phase 1
Hepatic Impairment
Phase 2
Acute Myeloid Leukemia
Phase 3
Leukemia
Datopotamab DeruxtecanOncology · TROP2 ADC
Phase 1
Advanced or Metastatic NSCLC
Phase 3
Metastatic Non Small Cell Lung Cancer (2)
Patritumab DeruxtecanOncology · HER3 ADC
Phase 2
Hormone Receptor Positive
Phase 3
Nonsquamous Non-small Cell Lung Cancer
R-DXdOncology
Phase 3
Fallopian Tube CancerSolid Cancer
Trastuzumab deruxtecan (DS-8201a)Oncology · HER2 ADC
Phase 1
Breast Cancer
Phase 3
Breast Cancer
Bempedoic acidCardiovascular · ACLY
Phase 3
Coronary Atherosclerosis
Dato-DXdOncology · TROP2 ADC
Phase 3
Urothelial Cancer
DS-1062aOncology · TROP2 ADC
Phase 3
Non-small Cell Lung Cancer
DS-8201aOncology · HER2 ADC
Phase 3
HER2-Positive Primary Breast Cancer
PexidartinibOncology · CSF1R/FLT3/KIT
Phase 3
Tenosynovial Giant Cell Tumor
T-DXdOncology
Phase 3
Advanced Cancer
Trastuzumab deruxtecan (T-DXd)Oncology · HER2 ADC
Phase 3
Breast Cancer
valemetostat tosylateOncology
Phase 1
Advanced Solid Tumor
Phase 2
Non-small Cell Lung CancerRelapsed/Refractory Peripheral T-Cell Lymphoma
DS-3939aOncology
Phase 2
Advanced Solid TumorSolid Tumor
HER3-DXdOncology
Phase 1
Non-Small Cell Lung Cancer (NSCLC)
Phase 2
Advanced Solid Tumor
Ifinatamab Deruxtecan (I-DXd)Oncology
Phase 2
Advanced Solid TumorExtensive-stage Small-cell Lung Cancer
DS-1001bOncology · IDH1
Phase 2
WHO Grade II Glioma
DS-5141bRare / Genetic
Phase 2
Duchenne Muscular Dystrophy
DS3790aOncology
Phase 2
Hematological Malignancies
Patritumab Deruxtecan (Fixed dose)Oncology · HER3 ADC
Phase 2
Non-Small Cell Lung Cancer Metastatic
Quizartinib High DoseOncology
Phase 2
Acute Myeloid Leukemia
Raludotatug deruxtecanOncology
Phase 2
Advanced Solid Tumor
Datopotamab Deruxtecan (Dato-DXd)Oncology · TROP2 ADC
Phase 1
Hormone Receptor Positive Breast Cancer
DS-1055aOncology
Phase 1
Solid Tumor
DS-1103aOncology
Phase 1
Advanced Solid Tumor
DS-2243aOncology
Phase 1
Solid Tumors
DS-3201bOncology
Phase 1
Lymphoma, Malignant
DS-6000aOncology
Phase 1
Renal Cell Carcinoma
DS1025aOncology
Phase 1
Advanced Solid Tumor
DS3610aOncology
Phase 1
Solid Tumors
DS5361bOncology
Phase 1
Advanced Solid Tumor
DS9051bOncology
Phase 1
Advanced or Metastatic Adrenocortical Carcinoma
HER3-DXd (FL-DP)Oncology
Phase 1
Non-Small Cell Lung Cancer (NSCLC)
ValemetostatOncology
Phase 1
Metastatic Castration-resistant Prostate Cancer

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).

Targets from a ChEMBL (EMBL-EBI) snapshot dated 2026-08-20 · 310/1701 assets resolved when it was built

See the full biopharma catalyst calendar across all covered companies.