Monday, January 5, 2026
141 days ago
delayed Drug Information
- Drug Name
- Tividenofusp Alfa (DNL310) (CT.gov)
- Application Type
- BLA
- FDA Designations
- BreakthroughFast TrackOrphan DrugPriority Review
- Indication
- Hunter Syndrome (Mucopolysaccharidosis Type II)
- Approved As
- Tividenofusp Alfa (DNL310)
Filing Details
- Company
- Denali Therapeutics Inc. →
- Stock Ticker
- DNLI
- SEC CIK
- 0001714899
- Source
- GlobeNewswire →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Explore Denali Therapeutics Inc.
View Denali Therapeutics Inc.'s full pipeline, approved drugs, and clinical trials.
Data sourced from SEC EDGAR filings. Last updated: 2026-03-22. Report an issue