Denali Therapeutics
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Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)
First new FDA-approved treatment option in nearly 20 years for families living with this rare lysosomal storage disease.
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The New England Journal of Medicine Publishes Phase 1/2 Study of Denali Therapeutics’ Tividenofusp Alfa (DNL310) for Hunter Syndrome (MPS II)
The New England Journal of Medicine Publishes Phase 1/2 Study of Denali Therapeutics’ Tividenofusp Alfa (DNL310) for Hunter…
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Denali Therapeutics Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Tividenofusp Alfa for Hunter Syndrome (MPS II)
FDA assigns PDUFA target action date of January 5, 2026, for decision on accelerated approval.
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Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) with Tividenofusp Alfa
Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) with…
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Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)
Denali expects to submit a Biologics License Application for tividenofusp alfa in early 2025 for regulatory review under…
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Denali Therapeutics Announces FDA Has Selected DNL126 for MPS IIIA for START Pilot Program Intended to Accelerate Development of Rare Disease Therapies
START is a pilot program newly launched jointly by the FDA CDER and CBER divisions to further accelerate…
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