Posted by Michael Wonder on 13 Oct 2025
Denali Therapeutics announces FDA review extension of BLA for tividenofusp alfa for the treatment of MPS II (Hunter syndrome)
13 October 2025 - Denali Therapeutics today announced that the US FDA has extended its review timeline of the biologics license application seeking accelerated approval of tividenofusp alfa for the treatment of mucopolysaccharidosis type II, also known as Hunter syndrome.
The PDUFA target date has been extended from 5 January 2026, to 5 April 2026.
