Denali to File for Accelerated Approval for Treatment of MPS II (Hunter Syndrome)

 

• Recent successful meeting with the FDA provides path to file for accelerated approval and subsequent conversion to full approval
  
• Plan to submit biologics license application (BLA) early in 2025 under the accelerated approval pathway
  
• New Phase 1/2 data will be presented this week at SSIEM 2024 demonstrating robust and durable biomarker responses and positive effects on clinical outcomes

https://www.globenewswire.com/news-release/2024/09/03/2939656/0/en/Denali-Therapeutics-Announces-Successful-Meeting-with-the-FDA-and-Plans-to-File-for-Accelerated-Approval-of-Tividenofusp-Alfa-DNL310-for-the-Treatment-of-MPS-II-Hunter-Syndrome.html