Denali Therapeutics outlines 2026 milestones including Hunter syndrome launch

Denali Therapeutics Inc. (NASDAQ: DNLI) announced anticipated milestones for 2026, including preparation for the commercial launch of tividenofusp alfa for Hunter syndrome pending FDA approval.

The company is preparing for a regulatory decision on its Biologics License Application for tividenofusp alfa under the FDA's accelerated approval pathway, with a target action date of April 5, 2026. Results from the open-label Phase 1/2 clinical trial were published in The New England Journal of Medicine on January 1, 2026.

Denali expects multiple clinical data readouts in 2026, including initial data from its Phase 1/2 study of DNL126 for Sanfilippo syndrome Type A, which will be presented at the 2026 WORLD Symposium in February. The company also anticipates data from its LRRK2 inhibitor program for Parkinson's disease and frontotemporal dementia studies.

The company plans to initiate first-in-human clinical studies for two Alzheimer's disease programs and one Pompe disease program. The FDA has approved the Clinical Trial Application for DNL628, an oligonucleotide therapy targeting tau protein for Alzheimer's disease. The FDA also lifted a clinical hold on DNL952 for Pompe disease, allowing the Phase 1 study to proceed.

As of September 30, 2025, Denali reported approximately $872.9 million in cash, cash equivalents and marketable securities. In December 2025, the company completed an equity financing with gross proceeds of approximately $200 million and announced a royalty funding agreement with Royalty Pharma for up to $275 million based on future sales of tividenofusp alfa.

Denali maintains active collaborations with Biogen for its Parkinson's disease program and with Takeda for its frontotemporal dementia program, both with 50/50 U.S. commercial rights. The company also receives royalty payments for a program licensed to Sanofi.

You May Also Be Interested In

• Wolfe Research Upgrades Janux Therapeutics (JANX) to Outperform, 'An ARM Out of the Penalty Box'
• JPMorgan Starts Reformation Inc (REF) at Overweight
• Mizuho Starts Jersey Mike's Subs (JMKE) at Outperform