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Denali Therapeutics Initiates BLA Filing Ror Accelerated Approval Of Tividenofusp Alfa For Treatment Of Hunter Syndrome And Positive Ongoing Interactions With FDA On DNL126 Through START Program

Author: Benzinga Newsdesk | April 02, 2025 07:09am
  • Rolling submission of BLA initiated for tividenofusp alfa; preparations ongoing for potential U.S. commercial launch in late 2025 or early 2026
  • Alignment through recent interactions with CDER on path to accelerated approval and conversion to full approval for tividenofusp alfa
    • Productive collaboration continues under START for an accelerated development and approval path for DNL126
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