Denali Therapeutics' ALS Study Fails to Meet Primary Goal; Shares Plunge 19% After Market Close

Investing.com -- Biopharmaceutical company Denali Therapeutics experienced a 19% decline in after-hours trading following the announcement that its amyotrophic lateral sclerosis (ALS) study did not meet its primary endpoint. The study evaluated the eIF2B agonist DNL343 as a potential treatment for ALS under the Phase 2/3 HEALEY ALS Platform Study's G Regimen.

According to the company’s press release, the trial failed to achieve its primary objective of demonstrating efficacy in slowing disease progression compared to placebo. Additionally, key secondary endpoints, which included measurements of muscle strength and respiratory function, did not show significant differences between the active and placebo groups at week 24.

Despite the failure to meet both the primary and secondary endpoints, DNL343 was found to be safe and well-tolerated by patients. Denali Therapeutics also indicated that further analysis is planned for the later stages of 2025.