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DENALI THERAPEUTICS INC. (DNLI)

(10% Negative) DENALI THERAPEUTICS INC. (DNLI) Announces Delay in approval Trials for AVLAYAH™ (tividenofusp alfa-eknm) Due to Pandemic-Related Challenges, Patient Enrollment Issues, Regulatory Process, Safety Review, Efficacy Assessment

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  • News bot March 25, 2026, 7:13 p.m.

    📋 DENALI THERAPEUTICS INC. (DNLI) - Clinical Trial Update

    Filing Date: 2026-03-25

    Accepted: 2026-03-25 15:13:02

    Event Type: Clinical Trial Update

    Event Details:

    DENALI THERAPEUTICS INC. (DNLI) Announces Clinical Trial Update DENALI THERAPEUTICS INC. (DNLI) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: approval
    • Diseases/Conditions: AVLAYAH™ (tividenofusp alfa-eknm)
    • Update Type: Trial Timeline Adjustment
    • Primary Factors: Pandemic-Related Challenges, Patient Enrollment, Regulatory Process, Regulatory Timeline
    • Collaboration: GLOBE NEWSWIRE

    🔬 Clinical Development Pipeline (DENALI THERAPEUTICS INC.):

    Product Type Development Stage Therapeutic Area Source
    tividenofusp alfa DRUG Phase PHASE2 Mucopolysaccharidosis II ClinicalTrials.gov
    Placebo DRUG Phase PHASE1 Alzheimer Disease, Early Onset ClinicalTrials.gov
    DNL628 DRUG Phase PHASE1 Alzheimer Disease, Early Onset ClinicalTrials.gov
    BIIB122-Matching Placebo OTHER Phase PHASE2 Parkinson Disease ClinicalTrials.gov
    BIIB122 225 mg DRUG Phase PHASE2 Parkinson Disease ClinicalTrials.gov
    Matching Placebo DRUG Phase PHASE2 Amyotrophic Lateral Sclerosis ClinicalTrials.gov
    DNL343 DRUG Phase PHASE2 Amyotrophic Lateral Sclerosis ClinicalTrials.gov
    DNL952 DRUG Phase PHASE1 Late-onset Pompe Disease ClinicalTrials.gov
    DNL593 DRUG Phase PHASE1 Frontotemporal Dementia ClinicalTrials.gov
    DNL126 DRUG Phase PHASE1 Mucopolysaccharidosis Type IIIA 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 INC.
    • Ticker Symbol: DNLI

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