CSL Limited (CSL.AX) — Upcoming Catalysts

FDA PDUFA dates, advisory-committee meetings, and Phase 2/3 readout windows for CSL 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 CSL.AX live on Mooboard →

31–90 days1

  • Oct 26, 2026
    CSL Limited(CSL.AX)Phase 2/3 readout
    Recombinant single-chain factor VIII (rVIII-SingleChain) · Phase 3 · Congenital Hemophilia A
    NCT06738485: Recombinant Single-chain Factor VIII (rVIII-SingleChain) in Chinese Participants With Hemophilia A Previously Treated With FVIII Products. Primary completion 2026-10-26 (estimated); status ACTIVE_NOT_RECRUITING.
    ClinicalTrials.gov ↗

Later10

  • Apr 6, 2027
    CSL Limited(CSL.AX)Phase 2/3 readout
    BE1116 · Phase 3 · Complex Cardiovascular Surgery With Cardiopulmonary Bypass
    NCT07094087: Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB). Primary completion 2027-04-06 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Sep 1, 2027
    CSL Limited(CSL.AX)Phase 2/3 readout
    CSL511 Fibrinogen concentrate (human) · Phase 3 · Acquired Fibrinogen Deficiency
    NCT06617897: Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery. Primary completion 2027-09-01 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Oct 22, 2027
    CSL Limited(CSL.AX)Phase 2/3 readout
    CSL889 · Phase 2 · Sickle Cell Disease Vaso-occlusive Crisis
    NCT06699849: Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis. Primary completion 2027-10-22 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Feb 28, 2028
    CSL Limited(CSL.AX)Phase 2/3 readout
    CSL787 · Phase 2 · Non-cystic Fibrosis Bronchiectasis
    NCT07048262: Dose Range Finding, Efficacy, and Safety Study of Nebulized CSL787 in Adults With Non-cystic Fibrosis Bronchiectasis (NCFB). Primary completion 2028-02-28 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Apr 15, 2028
    CSL Limited(CSL.AX)Phase 2/3 readout
    Vamifeport · Phase 2 · Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis
    NCT07332091: Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis. Primary completion 2028-04-15 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Jun 29, 2028
    CSL Limited(CSL.AX)Phase 2/3 readout
    Anumigilimab · Phase 2 · Sickle Cell Disease
    NCT07224360: Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD). Primary completion 2028-06-29 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Oct 4, 2028
    CSL Limited(CSL.AX)Phase 2/3 readout
    CSL222 (AAV5-hFIXco-Padua) · Phase 3 · Hemophilia B
    NCT06003387: Efficacy and Safety of CSL222 (Etranacogene Dezaparvovec) Gene Therapy in Adults With Hemophilia B With Pretreatment Adeno-associated Virus Serotype 5 (AAV5) Neutralizing Antibodies (Nabs). Primary completion 2028-10-04 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Mar 13, 2029
    CSL Limited(CSL.AX)Phase 2/3 readout
    IgPro20 · Phase 3 · Secondary Immune Deficiency
    NCT07648264: Single-arm Study of IgPro20 in Adults With Secondary Immune Deficiencies Due to Hematologic Malignancies Treated With B-cell Targeting Chimeric Antigen Receptor T-cell and T-cell Redirecting Therapies. Primary completion 2029-03-13 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • May 22, 2029
    CSL Limited(CSL.AX)Phase 2/3 readout
    CSL300 · Phase 2 / Phase 3 · End Stage Kidney Disease
    NCT05485961: Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD). Primary completion 2029-05-22 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗
  • Oct 24, 2033
    CSL Limited(CSL.AX)Phase 2/3 readout
    CSL222 (Adeno-associated viral vector serotype 5 [AAV5]-hFIXco-Padua) · Phase 3 · Hemophilia B
    NCT07080905: Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or Moderately Severe Hemophilia B. Primary completion 2033-10-24 (estimated); status RECRUITING.
    ClinicalTrials.gov ↗

How CSL Limited has moved — past-year price reactions

How binary is CSL.AX? 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)
3
±10% days
40.8%
annualized vol
254
trading days
Largest single-day moves
  • +17.3%2026-08-18no matched headline
  • -16%2026-05-11no matched headline
  • -15.9%2025-10-27no matched headline
  • +7.6%2026-06-19no matched headline
  • +7.2%2026-07-29no matched headline
  • -6.9%2026-02-11no 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.

CSL Limited — active clinical pipeline

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

13 assets14 programsPh1 1Ph2 4Ph3 7· 2 post-marketing (Ph4)
AreasImmunologyCardiovascularRare / GeneticOther
CSL300Other
Phase 1
End Stage Kidney Disease (ESKD)
Phase 3
End Stage Kidney Disease
BE1116Cardiovascular
Phase 3
Complex Cardiovascular Surgery With Cardiopulmonary Bypass
CSL222 (AAV5-hFIXco-Padua)Rare / Genetic
Phase 3
Hemophilia B
CSL222 (Adeno-associated viral vector serotype 5 [AAV5]-hFIXco-Padua)Rare / Genetic
Phase 3
Hemophilia B
CSL511 Fibrinogen concentrate (human)Other
Phase 3
Acquired Fibrinogen Deficiency
IgPro20Immunology
Phase 3
Secondary Immune Deficiency
Recombinant single-chain factor VIII (rVIII-SingleChain)Rare / Genetic
Phase 3
Congenital Hemophilia A
AnumigilimabRare / Genetic · CSF3R
Phase 2
Sickle Cell Disease
CSL787Rare / Genetic
Phase 2
Non-cystic Fibrosis Bronchiectasis
CSL889Rare / Genetic
Phase 2
Sickle Cell Disease Vaso-occlusive Crisis
VamifeportRare / Genetic
Phase 2
Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis

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.