DNLI catalyst calendar

Denali Therapeutics Inc.

Upcoming catalysts
10
Cash runway
16.2 months
Cash & investments
$710M
Phase 3 programs
2

Denali Therapeutics Inc. is tracked here for clinical trial milestones, SEC filings and earnings dates. Focus area: Biological Products, (No Diagnostic Substances).

The next scheduled catalyst is Next quarterly earnings (projected) on November 5, 2026, a projected date rather than a confirmed one. There are 10 upcoming events on record.

Cash runway is approximately 16.2 months based on the most recent reported cash position and quarterly operating burn as of 2026-06-30.

Across 10 concluded trials, 100% reached completion rather than being terminated or withdrawn.

Upcoming catalysts

DateEventTypePhase
November 5, 2026 est. Next quarterly earnings (projected) Earnings —
December 15, 2026 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN) Trial Milestone Phase 1/Phase 2
February 15, 2027 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease Trial Milestone Phase 1
March 15, 2027 Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD) Trial Milestone Phase 2
June 15, 2027 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 Trial Milestone Phase 2/Phase 3
December 15, 2027 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) Trial Milestone Phase 2/Phase 3
August 15, 2028 A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL952 in Adult Participants With Late-Onset Pompe Disease Trial Milestone Phase 1
August 15, 2028 Study of DNL126 in Pediatric Participants With Mucopolysaccharidosis Type IIIA (Sanfilippo Syndrome Type A) Trial Milestone Phase 1/Phase 2
April 15, 2030 A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of DNL921 in Healthy Participants and Participants With Alzheimer's Disease Trial Milestone Phase 1
February 15, 2031 A Study of Tividenofusp Alfa (DNL310) in Pediatric Participants With Hunter Syndrome Trial Milestone Phase 1/Phase 2

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Recent history

DateEventTypePhase
August 6, 2026 Quarterly results filed (8-K) Earnings —
July 28, 2026 8-K filed: Acquisition completed Corporate —
June 18, 2026 8-K filed: Material agreement, Reg FD disclosure Corporate —
May 22, 2026 8-K filed: Reg FD disclosure Filing —
May 7, 2026 Quarterly results filed (8-K) Earnings —
March 31, 2026 8-K filed: Reg FD disclosure Filing —
March 25, 2026 8-K filed: Reg FD disclosure Filing —
February 26, 2026 Quarterly results filed (8-K) Earnings —
January 6, 2026 8-K filed: Reg FD disclosure Filing —
December 10, 2025 8-K filed: Material agreement, Other event Corporate —
December 4, 2025 8-K filed: Material agreement Corporate —
December 4, 2025 8-K filed: Reg FD disclosure, Other event Filing —
November 6, 2025 Quarterly results filed (8-K) Earnings —
October 14, 2025 8-K filed: Reg FD disclosure Filing —
August 11, 2025 Quarterly results filed (8-K) Earnings —
July 7, 2025 8-K filed: Reg FD disclosure Filing —
June 3, 2025 8-K filed: Material agreement Corporate —
May 6, 2025 Quarterly results filed (8-K) Earnings —
April 30, 2024 A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants Trial Milestone Phase 1
June 8, 2023 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants Trial Milestone Phase 1
December 15, 2022 A Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of DNL343 in Participants With Amyotrophic Lateral Sclerosis Trial Milestone Phase 1
August 3, 2021 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL343 in Healthy Volunteers Trial Milestone Phase 1
June 4, 2021 A Study to Evaluate the Bioavailability and Safety of DNL343 in Healthy Volunteers Trial Milestone Phase 1
February 19, 2021 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Healthy Volunteers Trial Milestone Phase 1
December 6, 2019 Study to Evaluate DNL201 in Subjects With Parkinson's Disease Trial Milestone Phase 1
December 5, 2019 Study to Evaluate DNL747 in Subjects With Alzheimer's Disease Trial Milestone Phase 1
August 8, 2018 A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Healthy Volunteers Trial Milestone Phase 1

About this data

Trial milestones come from the ClinicalTrials.gov v2 API, filings from SEC EDGAR, and financial figures from SEC XBRL company facts. Dates marked est. are projected rather than company-confirmed. This is an information tool, not investment advice — verify anything you act on against the linked primary source.

Last updated 2026-10-14.