Denali Therapeutics seeks regulatory approval from the FDA for its therapy delivering the IDS enzyme.
4 reports, 3 independent
Updated Aug 12
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What happened
Denali Therapeutics seeks regulatory approval from the FDA for its therapy delivering the IDS enzyme.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.- Denali Therapeutics submitted a Biologics License Application (BLA) for its therapy and the FDA granted Priority Review.Sub-event
FDA accepted BLA for Denali Therapeutics' tividenofusp alfa.1 source
Denali Therapeutics seeks FDA approval for its IDS enzyme therapy.1 source
- FDA accepted BLA for Denali's drug using the IDS enzyme.
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The entities involved
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Coverage
Newest first; wire copies grouped- ZacksDNLI Tops on Q2 Earnings, Expects Decree on Hunter Syndrome Drug in '26 Denali Therapeutics (DNLI) reported a second-quarter 2025 loss of 72 cents per share, narrower than the Zacks Consensus Estimat
- GlobeNewswireDenali Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights Tividenofusp alfa BLA for Hunter syndrome accepted for priority review and assigned PDUFA target action date
- Insider MonkeyDenali Therapeutics Inc. (DNLI) Secures FDA Priority Review for First-Ever Brain-Penetrant Hunter Syndrome Therapy We recently compiled a list of 11 Best Future Stocks to Buy Now. Denali Therapeutics
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