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Denali Therapeutics

HQ: South San Francisco, CA source · denalitherapeutics.com ↗ · West Coast

FDA-approved therapeutic company FDA-cleared device company Clinical Phase 3

Location: South San Francisco, CA · source · Oct 15, 2026

Profile checked Oct 10, 2026

Keywords: Mucopolysaccharidosis II Parkinson Disease Alzheimer's Disease Late-onset Pompe Disease Mucopolysaccharidosis Type IIIA Early Onset Alzheimer Disease Frontotemporal Dementia Amyotrophic Lateral Sclerosis Alzheimer Disease DNL343 tividenofusp alfa DNL201 DNL921 DNL952 DNL126 DNL628 BIIB122 DNL593 DNL919 DNL151 DNL747

$475.0MRaised (2 yrs)19Trials (company is sponsor)1FDA records (2 yrs)

Timeline

  1. Trial start Phase 1: A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's Disease source ↗
  2. Trial start Phase 1: A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants With Late-Onset Pompe Disease source ↗
  3. FDA FDA New drug/biologic (novel): AVLAYAH (tividenofusp alfa-eknm) — BLA761485, Mar 24, 2026. Applicant at approval: Denali Therapeutics Inc. Accelerated approval. source ↗
  4. Trial start Phase 1: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease source ↗
  5. Raise Follow-on offering: $200M (total, as published), announced Dec 10, 2025. Source: SEC filing. source ↗
  6. Raise Private placement: $275M (total, as published), announced Dec 4, 2025. Source: SEC filing. source ↗
  7. Trial start Phase 2: Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD) source ↗
  8. Trial start 1: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants source ↗
  9. Trial start Phase 1/Phase 2: Study of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A) source ↗
  10. Trial start Phase 2/Phase 3: 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 source ↗
  11. Trial start Phase 2/Phase 3: 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 M source ↗
  12. Trial start Phase 1: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants source ↗
  13. Trial start Phase 1/Phase 2: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN) source ↗
  14. Trial start Phase 1: A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis source ↗
  15. Trial start Phase 1: A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers source ↗
  16. Trial start Phase 1/Phase 2: A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome source ↗
  17. Trial start Phase 1: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy Volunteers source ↗
  18. Trial start —: A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter Syndrome source ↗
  19. Trial start Phase 1: Study to Evaluate DNL747 in Subjects With Alzheimer's Disease source ↗
  20. Trial start Phase 1: Study to Evaluate DNL201 in Subjects With Parkinson's Disease source ↗
  21. Trial start Phase 1: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy Volunteers source ↗
  22. Trial start Phase 1: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy Volunteers source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Funding

Raised: $475.0M. Last 2 years.

Clinical trials (lead sponsor) 19

RecordTitlePhaseStatusStartPrimary completion
NCT05371613A 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)Phase 2/Phase 3Active, not recruitingJul 21, 20222027-12 (estimated)
NCT07758595A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's DiseasePhase 1RecruitingAug 7, 20262030-04 (estimated)
NCT07354724A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants With Late-Onset Pompe DiseasePhase 1RecruitingMay 12, 20262028-08 (estimated)
NCT06181136Study of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A)Phase 1/Phase 2Active, not recruitingDec 7, 20232028-08 (estimated)
NCT07328451A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's DiseasePhase 1RecruitingJan 30, 20262027-02 (estimated)
NCT06075537An 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-0007Phase 2/Phase 3Enrolling by invitationSep 20, 20232027-06 (estimated)
NCT06602193Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)Phase 2Active, not recruitingOct 24, 20242027-03 (estimated)
NCT05262023A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN)Phase 1/Phase 2Active, not recruitingFeb 1, 20222026-12 (estimated)
NCT04251026A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter SyndromePhase 1/Phase 2Active, not recruitingJul 16, 20202031-02 (estimated)
NCT05006352A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral SclerosisPhase 1CompletedAug 11, 2021Dec 15, 2022 (actual)
NCT06281158A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants1CompletedMar 1, 2024Apr 30, 2024 (actual)
NCT04007536A Study of Potential Treatment-Responsive Biomarkers and Clinical Outcomes in Hunter SyndromeNot listedCompletedOct 23, 2019Mar 1, 2024 (actual)
NCT05450549A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy ParticipantsPhase 1CompletedJul 14, 2022Jun 8, 2023 (actual)
NCT04557800A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy VolunteersPhase 1CompletedNov 16, 2017Feb 19, 2021 (actual)
NCT04268784A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy VolunteersPhase 1CompletedFeb 20, 2020Aug 3, 2021 (actual)
NCT04581772A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy VolunteersPhase 1CompletedDec 23, 2020Jun 4, 2021 (actual)
NCT04551534A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy VolunteersPhase 1CompletedJun 1, 2017Aug 8, 2018 (actual)
NCT03757325Study to Evaluate DNL747 in Subjects With Alzheimer's DiseasePhase 1CompletedFeb 13, 2019Dec 5, 2019 (actual)
NCT03710707Study to Evaluate DNL201 in Subjects With Parkinson's DiseasePhase 1CompletedDec 4, 2018Dec 6, 2019 (actual)

FDA records (last 2 years)

Raises and investors new

Form D raises come from the company’s own SEC filing (last 2 years).

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