Denali Therapeutics Drug Fails ALS Trial

Denali Therapeutics announced that its experimental drug DNL343 failed to meet primary and secondary endpoints in the Phase II/III HEALEY ALS platform study, which aimed to evaluate its efficacy in slowing progression of amyotrophic lateral sclerosis (ALS). The trial, involving 186 patients treated with DNL343 compared to 139 in the placebo group, showed no significant improvement in disease severity, muscle strength, or respiratory function after 24 weeks. However, the drug was reported to be safe and well tolerated, leading analysts to suggest that the disappointing results were somewhat expected given the challenges inherent in developing ALS therapies. Future analyses, including subgroup evaluations and biomarker assessments, are anticipated later in 2025. This setback follows another recent failure for Denali, raising concerns about the company's prospects in ALS treatment development. Despite the stock dip following the announcement, some analysts view it as a potential buying opportunity for investors.