Denali Therapeutics Announces U.S. FDA Breakthrough Therapy …
2 days ago · About Tividenofusp Alfa. Tividenofusp alfa (or DNL310) is composed of iduronate 2-sulfatase (IDS) fused to Denali’s proprietary Enzyme TransportVehicle™ (ETV), which is engineered for active ...
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy
1 day ago · About Tividenofusp Alfa. Tividenofusp alfa (or DNL310) is composed of iduronate 2-sulfatase (IDS) fused to Denali’s proprietary Enzyme TransportVehicle™ (ETV), which is engineered for active transport into the brain and broad delivery throughout the body with the goal of addressing behavioral, cognitive, and physical symptoms of Hunter ...
FDA Grants Breakthrough Therapy Designation to Denali’s Tividenofusp …
1 day ago · Tividenofusp alfa has been supported by data from an ongoing, open-label, single-arm phase 1/2 study and is also being studied in phase 2/3 COMPASS study (NCT05371613), a larger-scale trial pinning the agent against idursulfase for up to a 96-week treatment period.
FDA Grants Breakthrough Therapy Designation to Tividenofusp Alfa …
1 day ago · The FDA granted breakthrough therapy designation (BTD) for tividenofusp alfa (DNL310; Denali Therapeutics) for the treatment of patients with Hunter syndrome (MPS II), a rare genetic disease that can lead to physical, cognitive, and behavioral complications, according to a news release from Denali Therapeutics. 1
Denali's Hunter Syndrome Drug Gets FDA Breakthrough Status ...
2 days ago · About Tividenofusp Alfa. Tividenofusp alfa (or DNL310) is composed of iduronate 2-sulfatase (IDS) fused to Denali’s proprietary Enzyme TransportVehicle™ (ETV), which is engineered for active transport into the brain and broad delivery throughout the body with the goal of addressing behavioral, cognitive, and physical symptoms of Hunter ...
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy
2 days ago · About Tividenofusp Alfa. Tividenofusp alfa (or DNL310) is composed of iduronate 2-sulfatase (IDS) fused to Denali’s proprietary Enzyme TransportVehicle™ (ETV), which is engineered for active ...
Denali Therapeutics announces U.S. FDA BTD granted for tividenofusp
2 days ago · Denali Therapeutics announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, for tividenofusp alfa for the treatment of individuals with Hunter ...
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy …
2 days ago · About Tividenofusp Alfa. Tividenofusp alfa (or DNL310) is composed of iduronate 2-sulfatase (IDS) fused to Denali’s proprietary Enzyme TransportVehicle™ (ETV), which is engineered for active transport into the brain and broad delivery throughout the body with the goal of addressing behavioral, cognitive, and physical symptoms of Hunter ...
Denali Therapeutics Announces Successful Meeting with the FDA …
Sep 3, 2024 · Based on discussions with CDER, Denali will include preclinical and clinical data on biomarkers (CSF HS and neurofilament light (NfL)) and safety in the BLA for tividenofusp alfa as a treatment...
Denali Therapeutics Announces New Data and Expansion of Its
Feb 7, 2024 · New data show additional improvement and stabilization in clinical outcomes in MPS II with 104 weeks of tividenofusp alfa (DNL310) treatment in the open-label, single-arm Phase 1/2 study ...
- Some results have been removed