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742,968 Results for "denali therapeutics inc".
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Rare diseases
Denali’s Hunter Syndrome Candidate in the Spotlight After REGENXBIO Rejection
The Hunter syndrome space suffered a setback in February when the FDA turned down REGENXBIO’s investigational gene therapy, raising urgent questions about whether competitor Denali Therapeutics can clear the agency’s bar next month.
March 16, 2026
·
6 min read
·
Ben Hargreaves
Regulatory
FDA Pauses Denali’s Pompe Plans Due to Preclinical Safety Signals
Hypersensitivity reactions in a mouse model prompted the agency to suspend Denali’s planned Phase I development for DNL952 for Pompe disease.
December 5, 2025
·
2 min read
·
Tristan Manalac
Press Releases
Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)
March 25, 2026
·
17 min read
Press Releases
Denali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights
February 26, 2026
·
13 min read
Press Releases
Denali Therapeutics To Host Webcast Highlighting Presentations on Enzyme TransportVehicle™ Programs at the 2026 WORLDSymposium™
February 2, 2026
·
1 min read
Press Releases
Denali Therapeutics Announces Key Anticipated Milestones and Priorities for 2026 Including Commercial Launch of Tividenofusp Alfa for Hunter Syndrome
January 6, 2026
·
10 min read
Approvals
Denali Delivers ‘Welcome Positive’ for Rare Disease Space With FDA’s Hunter Syndrome Nod
Avlayah is the first Hunter syndrome therapy approved to address the condition’s neurologic complications, according to Tracy Beth Høeg, acting director of the Center for Drug Evaluation and Research.
March 26, 2026
·
3 min read
·
Tristan Manalac
Press Releases
Denali Therapeutics Presents Enzyme TransportVehicle™ Progress Across Three Clinical Programs for Treatment of Lysosomal Storage Disorders at 2026 WORLDSymposium™
February 5, 2026
·
15 min read
Press Releases
Denali Therapeutics Announces Board and Executive Leadership Updates
November 6, 2025
·
7 min read
Press Releases
Denali Therapeutics Announces Proposed Offering of Common Stock and Pre-Funded Warrants
December 10, 2025
·
3 min read
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