FDA Extends Review Timeline for Denali's Tividenofusp Alfa MPS II Therapy Filing
FDA extended the PDUFA review timeline for Denali Therapeutics’ BLA for tividenofusp alfa in Hunter syndrome, delaying the U.S. decision beyond the original target date. The extension raises uncertainty over launch timing and revenue forecasts for the company’s MPS II therapy.
1. FDA Review Extension Details
The FDA extended the review timeline for Denali's BLA seeking accelerated approval of tividenofusp alfa to treat Hunter syndrome. No updated decision date has been announced, reflecting the agency’s thorough evaluation process.
2. Impact on Launch and Financial Forecasts
This delay pushes potential market launch into an undefined period, heightening uncertainty around projected 2026 revenues tied to the MPS II therapy. It may also affect investor expectations for near-term cash flows.
3. Next Steps and Regulatory Engagement
Denali intends to engage with the FDA to clarify data requirements and may provide supplemental clinical or biomarker evidence. The company could request a formal meeting to define next steps and refine its regulatory strategy.