Denali Therapeutics begins marketing application for genetic disorder drug, shares rise

California-based drug developer Denali Therapeutics DNLI.O rise 11.4% to $13.70

DNLI says it has started the rolling submission of a marketing application for accelerated FDA approval of its experimental drug, tividenofusp alfa, to treat a type of rare genetic disorder called Hunter syndrome

Co says the drug is currently enrolling patients for a late-stage study

Hunter syndrome is where the body lacks an enzyme needed to break down certain sugars, causing these sugars to build up in the body, leading to various health problems

Co expects to complete the submission of marketing application in the first half of May 2025

DNLI plans a potential U.S. commercial launch in late 2025 or early 2026

Stock has fallen 34.5% YTD