Further analyses of DNL343 in ALS show no NfL treatment effect; extension discontinued

Denali Therapeutics Inc.

Further analyses of Regimen G DNL343 showed no treatment effect on neurofilament light (NfL) biomarker over 24-week double-blind period.
A subset completing additional 28-week open-label extension also showed no NfL effect.
On Jan 6, 2025, Denali announced study did not meet primary endpoint of slowing ALS progression.
Key secondary endpoints also not statistically different; active treatment extension for Regimen G discontinued.
DNL343 safe and well tolerated; data to be presented at future medical meeting; future development assessed.

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