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  • News bot April 7, 2026, 12:36 p.m.

    📋 ABEONA THERAPEUTICS INC. (ABEO) - Regulatory Update

    Filing Date: 2026-04-07

    Accepted: 2026-04-07 08:35:30

    Event Type: Regulatory Update

    Event Details:

    ABEONA THERAPEUTICS INC. (ABEO) Announces Regulatory Update ABEONA THERAPEUTICS INC. (ABEO) provided an update on regulatory developments for its product portfolio. Regulatory Update Details: • Applications: NDA (New Drug Application) • Regulatory Agencies: FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency) • Status: Rejected Clinical Development:

    🔬 Clinical Development Pipeline (ABEONA THERAPEUTICS INC.):

    Product Type Development Stage Therapeutic Area Source
    anti-CD19/BCMA CAR NK cells (KN5601-K) BIOLOGICAL Phase EARLY_PHASE1 Paediatric B Cell-related Autoimmune Diseases ClinicalTrials.gov
    EcoNail™ (econazole 5%/SEPA® 18% nail lacquer) DRUG Phase PHASE2 Onychomycosis ClinicalTrials.gov
    MSI-78 DRUG Phase PHASE3 Diabetic Foot Ulcers ClinicalTrials.gov
    ofloxacin DRUG Phase PHASE3 Diabetic Foot Ulcers ClinicalTrials.gov
    ABO-101 BIOLOGICAL Preclinical Mucopolysaccharidosis III-B ClinicalTrials.gov
    rAAV9.CMV.hNAGLU BIOLOGICAL Phase PHASE1 Mucopolysaccharidosis Type 3 B ClinicalTrials.gov
    LZRSE-Col7A1 Engineered Autologous Epidermal Sheets BIOLOGICAL Phase PHASE1 Epidermolysis Bullosa Dystrophica ClinicalTrials.gov
    EB-101 BIOLOGICAL Phase PHASE3 Epidermolysis Bullosa ClinicalTrials.gov
    EB-101 Surgical application of RDEB wounds BIOLOGICAL Phase PHASE3 Epidermolysis Bullosa ClinicalTrials.gov

    💼 Business Developments:

    • Partnership: Not available
    • Acquisition
    • Licensing: Not available
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: ABEONA THERAPEUTICS INC.
    • Ticker Symbol: ABEO

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