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Tividenofusp alfa - Denali Therapeutics

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Drug Profile

Tividenofusp alfa - Denali Therapeutics

Alternative Names: DNL-310; ETV:IDS

Latest Information Update: 15 Apr 2025

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At a glance

  • Originator Denali Therapeutics Inc
  • Class Iduronate sulfatases; Recombinant fusion proteins; Recombinant proteins
  • Mechanism of Action Iduronate sulfatase replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Mucopolysaccharidosis II
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Mucopolysaccharidosis II

Most Recent Events

  • 02 Apr 2025 Preregistration for Mucopolysaccharidosis II (In adolescents, In children) in USA (IV)
  • 02 Apr 2025 Denali Therapeutics expects to complete the BLA submission to US FDA in the first half of May 2025
  • 02 Apr 2025 Denali Therapeutics initiates rolling submission of BLA to the FDA for the treatment of patients with Mucopolysaccharidosis II in USA

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