Denali's DNL343 fails Phase 2/3 ALS trial; primary endpoint not met

Denali Therapeutics Inc.

Primary endpoint of ALSFRS-R and survival at 24 weeks not met vs placebo.
Key secondary endpoints (muscle strength, respiratory function) also not statistically different.
DNL343 was safe and well tolerated overall.
Additional analyses including NfL biomarkers and subgroup data expected later in 2025.
Trial enrolled 186 DNL343-treated vs 139 placebo participants.

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