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Cabaletta Bio Inc (CABA)

(30% Negative) Cabaletta Bio Inc (CABA) Announces Delay in expected Trials for 1H26 to confirm GMP readiness Due to Pandemic-Related Challenges, Patient Enrollment Issues, Regulatory Process, Manufacturing Considerations, Safety Review, Efficacy Assessment

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  • News bot Jan. 30, 2026, 8:13 a.m.

    📋 Cabaletta Bio Inc (CABA) - Clinical Trial Update

    Filing Date: 2026-01-12

    Accepted: 2026-01-12 08:02:10

    Event Type: Clinical Trial Update

    Event Details:

    Cabaletta Bio Inc (CABA) Announces Clinical Trial Update Cabaletta Bio Inc (CABA) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: expected, achieved
    • Diseases/Conditions: 1H26 to confirm GMP readiness
    • Clinical Stage: Phase 1
    • Update Type: Trial Timeline Adjustment
    • Primary Factors: Pandemic-Related Challenges, Patient Enrollment, Regulatory Process
    • Collaboration: FDA
      • anticipated in lupus, scleroderma and myasthenia gravis in 1H26 FDA alignment on registrational study achieved in SLE and LN for small single-arm cohorts; strategically prioritizing no preconditioning regimen pending dose-ranging data PHILADELPHIA, Jan. 12, 2026
      • expected in 1H26 to confirm GMP readiness, including supply chain logistics New durability data without preconditioning and higher dose initial clinical data from RESET-PV™ expected in 1H26; dose-ranging data from RESET-SLE™ without preconditioning anticipated in 2026
      • expected in 1H26: Following the presentation of complete Phase 1/2 clinical data from RESET-Myositis cohorts in 2025

    🔬 Clinical Development Pipeline (Cabaletta Bio Inc):

    Product Type Development Stage Therapeutic Area Source
    CABA-201 BIOLOGICAL Phase PHASE1 Generalized Myasthenia Gravis (gMG) ClinicalTrials.gov
    DSG3-CAART BIOLOGICAL Phase PHASE1 Pemphigus Vulgaris ClinicalTrials.gov
    MuSK-CAART BIOLOGICAL Phase PHASE1 MuSK Myasthenia Gravis ClinicalTrials.gov
    CABA-201 following preconditioning with fludarabine and cyclophosphamide BIOLOGICAL Phase PHASE1 Idiopathic Inflammatory Myopathy ClinicalTrials.gov
    DSG3-CAART or CABA-201 BIOLOGICAL Phase PHASE1 Pemphigus Vulgaris ClinicalTrials.gov

    💼 Business Developments:

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

    Structured Data:

    • Company Name: Cabaletta Bio Inc
    • Ticker Symbol: CABA

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