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

Denali Therapeutics

02/04/2025 16:48

** 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

(Reporting by Siddhi Mahatole)

((siddhi.mahatole@thomsonreuters.com))