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Denali Therapeutics Inc. (DNLI)

Denali Therapeutics Inc. is a biopharmaceutical firm, founded in 2013 and based in South San Francisco, California, which focuses on identifying and advancing treatments for neurodegenerative conditions within the United States. The company, initially known as SPR Pharma Inc. until its renaming in March 2015, possesses a robust development pipeline. This includes BIIB122/DNL151, a small molecule inhibitor targeting leucine-rich repeat kinase 2 (LRRK2), currently in Phase 1 and Phase 1b clinical trials for Parkinson's disease. Another candidate, DNL310, is progressing through Phase 1/2 clinical studies for Hunter syndrome. For amyotrophic lateral sclerosis (ALS), DNL343 is in Phase 1 trials, while AR443820/DNL788 has successfully concluded its Phase 1 clinical trial for ALS, multiple sclerosis (MS), and Alzheimer's disease. Furthermore, SAR443122/DNL758 is undergoing Phase 2 clinical trials for cutaneous lupus erythematosus. Denali Therapeutics is engaged in extensive collaborative efforts with a range of partners, including Takeda Pharmaceutical Company, Genentech, Inc., Sanofi, F-star Gamma Limited, F-star Biotechnologische Forschungs-Und Entwicklungsges M.B.H, F-star Biotechnology Limited, SIRION Biotech GmbH, Genzyme Corporation, Harvard University, the Michael J. Fox Foundation, and Centogene. It also maintains a research and option agreement with Secarna Pharmaceuticals GmbH & Co. KG to co-develop antisense therapies specifically for neurodegenerative diseases.

Sector: Biological Products, (No Diagnostic Substances)

Industry: Biotechnology

Denali Therapeutics Inc. logo

Denali Therapeutics Inc.

NASDAQ:DNLIHealthcare
-1.97%$18.94
AH$19.00+0.32%vs close
Mkt Cap$3.03B
Float133.14M
O/S159.85M
Vol
$ Vol
RVOL
Inst Own97.8%
SI11.6%
Earnings
Dilution
Denali Therapeutics Inc. logoNASDAQ:DNLI$18.94-1.97%
Phase Distribution
19 lead-sponsored trials·9 active·10 completed
Phase 112
Phase 1/23
Phase 21
Phase 2/32
Not applicable1
(7 more as collaborator)
Status Overview
Recruiting4
Active, not recruiting5
Completed10

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 2/3
    Active, not recruiting

    A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)

    tividenofusp alfa, idursulfase

    Mucopolysaccharidosis II

    Enrollment
    65
    Start
    Jul 2022
    Primary Completion
    Dec 2027est.
    Completion
    Dec 2027est.
    NCT05371613
  • Phase 2/3
    Enrolling by invitation

    An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007

    tividenofusp alfa

    Mucopolysaccharidosis II

    Enrollment
    99
    Start
    Sep 2023
    Primary Completion
    Jun 2027est.
    Completion
    Jun 2027est.
    NCT06075537
  • Phase 2
    Active, not recruiting

    Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)

    BIIB122 225 mg

    Parkinson Disease

    Enrollment
    50
    Start
    Oct 2024
    Primary Completion
    Mar 2027est.
    Completion
    Feb 2028est.
    NCT06602193
  • Phase 1/2
    Active, not recruiting

    A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome

    tividenofusp alfa

    Mucopolysaccharidosis II

    Enrollment
    47
    Start
    Jul 2020
    Primary Completion
    Feb 2031est.
    Completion
    Feb 2031est.
    NCT04251026
  • Phase 1/2
    Active, not recruiting

    A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)

    DNL593, Placebo

    Frontotemporal Dementia

    Enrollment
    85
    Start
    Feb 2022
    Primary Completion
    Dec 2026est.
    Completion
    Nov 2028est.
    NCT05262023
  • Phase 1/2
    Active, not recruiting

    Study of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A)

    DNL126

    Mucopolysaccharidosis Type IIIA

    Enrollment
    20
    Start
    Dec 2023
    Primary Completion
    Aug 2028est.
    Completion
    Aug 2028est.
    NCT06181136
  • Phase 1
    Completed

    Study to Evaluate DNL201 in Subjects With Parkinson's Disease

    DNL201, Placebo

    Parkinson Disease

    Enrollment
    29
    Start
    Dec 2018
    Primary Completion
    Dec 2019
    Completion
    Dec 2019
    NCT03710707
  • Phase 1
    Completed

    Study to Evaluate DNL747 in Subjects With Alzheimer's Disease

    DNL747, Placebo

    Alzheimer Disease

    Enrollment
    16
    Start
    Feb 2019
    Primary Completion
    Dec 2019
    Completion
    Dec 2019
    NCT03757325
  • Phase 1
    Completed

    A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy Volunteers

    DNL343, Placebo

    Healthy Volunteers

    Enrollment
    96
    Start
    Feb 2020
    Primary Completion
    Aug 2021
    Completion
    Aug 2021
    NCT04268784
  • Phase 1
    Completed

    A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy Volunteers

    DNL201, Placebo

    Healthy Volunteers

    Enrollment
    122
    Start
    Jun 2017
    Primary Completion
    Aug 2018
    Completion
    Aug 2018
    NCT04551534
  • Phase 1
    Completed

    A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy Volunteers

    DNL151, Placebo

    Healthy Volunteers

    Enrollment
    186
    Start
    Nov 2017
    Primary Completion
    Feb 2021
    Completion
    Feb 2021
    NCT04557800
  • Phase 1
    Completed

    A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers

    DNL343, Placebo

    Healthy Volunteers

    Enrollment
    31
    Start
    Dec 2020
    Primary Completion
    Jun 2021
    Completion
    Jun 2021
    NCT04581772
  • Phase 1
    Completed

    A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis

    DNL343, Placebo

    Amyotrophic Lateral Sclerosis

    Enrollment
    29
    Start
    Aug 2021
    Primary Completion
    Dec 2022
    Completion
    Jun 2024
    NCT05006352
  • Phase 1
    Completed

    A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants

    DNL919, Placebo

    Healthy Participant

    Enrollment
    47
    Start
    Jul 2022
    Primary Completion
    Jun 2023
    Completion
    Jun 2023
    NCT05450549
  • Phase 1
    Completed

    A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants

    [14C]-DNL343

    Healthy Volunteers

    Enrollment
    7
    Start
    Mar 2024
    Primary Completion
    Apr 2024
    Completion
    Apr 2024
    NCT06281158
  • Phase 1
    Recruiting

    A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease

    DNL628, Placebo

    Alzheimer Disease, Early Onset

    Enrollment
    68
    Start
    Jan 2026
    Primary Completion
    Feb 2027est.
    Completion
    Feb 2027est.
    NCT07328451
  • Phase 1
    Recruiting

    A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants With Late-Onset Pompe Disease

    DNL952

    Late-onset Pompe Disease

    Enrollment
    32
    Start
    May 2026
    Primary Completion
    Aug 2028est.
    Completion
    Aug 2028est.
    NCT07354724
  • Phase 1
    Recruiting

    A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's Disease

    DNL921, Placebo

    Alzheimer's Disease, Healthy Participants

    Enrollment
    178
    Start
    Aug 2026
    Primary Completion
    Apr 2030est.
    Completion
    Apr 2030est.
    NCT07758595
  • Observational
    Completed

    A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter Syndrome

    No Intervention

    Mucopolysaccharidosis II

    Enrollment
    18
    Start
    Oct 2019
    Primary Completion
    Mar 2024
    Completion
    Mar 2024
    NCT04007536
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