Shots:
- The US FDA has accepted BLA & granted priority review to tividenofusp alfa for the treatment of Hunter syndrome (MPS II), with PDUFA target action date of Jan 5, 2026
- BLA was supported by a P-I/II trial of tividenofusp alfa in 47 MPS II pts, as Denali prepares for its US commercial launch. It is also being evaluated in the P-II/III (COMPASS) trial against idursulfase for MPS II to support global approvals, with active enrollment across North America, South America, & EU
- Tividenofusp alfa combines iduronate 2-sulfatase (IDS) with Denali’s proprietary Enzyme TransportVehicle (ETV), designed for active brain transport & broad body distribution to target the behavioral, cognitive, & physical symptoms of MPS II
Ref: Globenewswire | Image: Denali Therapeutics | Press Release
Related News:- REGENXBIO Reports the US FDA’s BLA Acceptance and Priority Review of RGX-121 for Treating Mucopolysaccharidosis II
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
