Denali Therapeutics Faces Setback as Sanofi’s Mid-Stage ALS Therapy Trial Misses Main Goal

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Exterior view of the Sanofi headquarters building

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  • Shares of Denali Therapeutics (NASDAQ:DNLI) opened lower on Friday after the company said its partner Sanofi (NASDAQ:SNY) has faced a setback in a mid-stage trial for a jointly developed neurology candidate called SAR443820 (DNL788).
  • Denali Therapeutics stock fell as Sanofi announced that the Phase 2 trial named HIMALAYA did not meet the main goal in patients with the rare neurological disease, amyotrophic lateral sclerosis (ALS).
  • Sanofi stated that SAR443820 (DNL788), an oral RIPK1 Inhibitor, did not achieve the primary endpoint of change in a clinical measure called the ALS Functional Rating Scale-Revised (ALSFRS-R) in the trial.
  • Although the therapy missed the mark in ALS, Sanofi plans to advance it in another Phase 2 trial for multiple sclerosis, an immune-mediated neurological condition.
  • SAR443820 (DNL788) is undergoing two mid-stage clinical trials for ALS and MS as part of a 2018 collaboration agreement between the two companies.


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