Denali outlines 2026 milestones: PDUFA April 5 for Hunter syndrome, multiple pipeline readouts

Denali Therapeutics Inc.

Preparing for commercial launch of tividenofusp alfa (Hunter syndrome) with PDUFA target action date April 5, 2026; results published in NEJM.
Expect multiple clinical data readouts: Phase 1/2 DNL126 for Sanfilippo type A, Phase 1/2 DNL593 for FTD-GRN, Phase 2b LUMA for Parkinson's (BIIB122).
Initiate Phase 1b for DNL628 (OTV:MAPT) in Alzheimer's; FDA lifted clinical hold on DNL952 for Pompe disease; Phase 1 start.
Completed equity financing (~$200M gross) and royalty funding from Royalty Pharma up to $275M; cash as of Sep 30, 2025: ~$872.9M.
Partnerships: Biogen (Parkinson's, 50/50 US), Takeda (FTD-GRN, 50/50 US), Sanofi (RIPK1 inhibitor in UC, royalties).

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.