Denali Therapeutics (DNLI) Weighs FDA Priority Review And Rival Setback: What Does It Mean Long Term?
- Denali Therapeutics recently highlighted past and upcoming presentations of clinical and preclinical data for its Enzyme Transport Vehicle programs in rare lysosomal storage disorders, alongside an ongoing FDA Priority Review of tividenofusp alfa for Hunter syndrome with a decision expected by 5 April 2026.
- The FDA’s halt of a competing Hunter syndrome gene therapy trial has drawn attention to Denali’s ETV platform as a potential alternative approach for delivering enzyme replacement therapies to the brain and body.
- We’ll now examine how the competitor trial halt and Denali’s pending FDA decision shape the company’s longer-term investment narrative.
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