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Denali Therapeutics (DNLI)

(90% Positive) Denali Therapeutics Inc. (DNLI) Announces Enrollment Update for year Due to Patient Enrollment Issues, Regulatory Process, Safety Review, Efficacy Assessment

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  • News bot Jan. 6, 2026, 1:07 p.m.

    📋 Denali Therapeutics Inc. (DNLI) - Clinical Trial Update

    Filing Date: 2026-01-06

    Accepted: 2026-01-06 08:02:38

    Event Type: Clinical Trial Update

    Event Details:

    Denali Therapeutics (DNLI) Announces Clinical Trial Update Denali Therapeutics (DNLI) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: year
    • Diseases/Conditions: Denali as we prepare to deliver our f, neurodegenerative diseases
    • Collaboration: MAPT
      • targeting the MAPT gene that encodes for tau. Denali today announced that the Clinical Trial Application (CTA) for the Phase 1b study of DNL628 has been approved and study start-up activities are underway. DNL952 (ETV:GAA) for Pompe diseaseDNL952 is enabled by Denali’s Enzyme TransportVehicleTM (ETV) and designed to enhance delivery of the missing enzyme, GAA, into muscle tissues and across the blood-brain barrier into the brain. Denali today announced that the U.S. FDA has lifted the clinical hold on the Investigational New Drug (IND) application for DNL952, and Denali will proceed with the Phase 1 study.BIIB122/DNL151 (small molecule LRRK2 inhibitor) for Parkinson’s diseaseThe global Phase 2b LUMA study of BIIB122 completed enrollment of participants with early-stage Parkinson’s disease in 2025
      • expected in 2026

    🔬 Clinical Development Pipeline (Denali Therapeutics Inc.):

    Product Type Development Stage Therapeutic Area Source
    DNL126 DRUG Phase PHASE1 Mucopolysaccharidosis Type IIIA ClinicalTrials.gov
    tividenofusp alfa DRUG Phase PHASE2 Mucopolysaccharidosis II ClinicalTrials.gov
    BIIB122-Matching Placebo OTHER Phase PHASE2 Parkinson Disease ClinicalTrials.gov
    BIIB122 225 mg DRUG Phase PHASE2 Parkinson Disease ClinicalTrials.gov
    Placebo DRUG Phase PHASE2 Parkinson Disease ClinicalTrials.gov
    IkT-148009 (risvodetinib) DRUG Phase PHASE2 Parkinson Disease ClinicalTrials.gov

    💼 Business Developments:

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

    Structured Data:

    • Company Name: Denali Therapeutics
    • CIK: 0001714899
    • Ticker Symbol: DNLI
    • Period End Date: 2026-01-06
    • Document Type: 8-K

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