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  • News bot Jan. 8, 2026, 9:04 p.m.

    📋 Anika Therapeutics, Inc. (ANIK) - Regulatory Update

    Filing Date: 2026-01-08

    Accepted: 2026-01-08 16:02:04

    Event Type: Regulatory Update

    Event Details:

    Anika Therapeutics Inc. (ANIK) Announces Regulatory Update Anika Therapeutics Inc. (ANIK) provided an update on regulatory developments for its product portfolio. Regulatory Update Details: • Applications: BLA (Biologics License Application), NDA (New Drug Application) • Regulatory Agencies: FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency) • Status: Approved, Rejected Clinical Development:

    🔬 Clinical Development Pipeline (Anika Therapeutics, Inc.):

    Product Type Development Stage Therapeutic Area Source
    NKT5097 CDK2/CDK4 dual degrader DRUG Phase PHASE1 HR+ Breast Cancer ClinicalTrials.gov
    NKT3964 DRUG Phase PHASE1 Solid Tumor ClinicalTrials.gov
    Semaglutide 1 mg DRUG Phase PHASE2 Diabetes Mellitus, Type 2 ClinicalTrials.gov
    HT-6184 Matching Placebo DRUG Phase PHASE2 Diabetes Mellitus, Type 2 ClinicalTrials.gov
    HT-6184 DRUG Phase PHASE2 Diabetes Mellitus, Type 2 ClinicalTrials.gov
    Cetrelimab DRUG Phase PHASE1 Non Small Cell Lung Cancer ClinicalTrials.gov
    tolododekin alfa DRUG Phase PHASE1 Non Small Cell Lung Cancer ClinicalTrials.gov
    Integrity Implant System DEVICE Approved Rotator Cuff Tears of the Shoulder ClinicalTrials.gov
    Oral NKT2152 DRUG Phase PHASE1 ccRCC ClinicalTrials.gov
    Anika Integrity Implant System DEVICE Preclinical Rotator Cuff Tears ClinicalTrials.gov

    💼 Business Developments:

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

    Structured Data:

    • Company Name: Anika Therapeutics Inc.
    • CIK: 0000898437
    • Ticker Symbol: ANIK
    • Period End Date: 2026-01-07
    • Document Type: 8-K

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