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Denali Therapeutics’ ALS drug fails in mid-to-late stage trial

By Thomson Reuters Jan 6, 2025 | 3:43 PM

(Reuters) -Denali Therapeutics said on Monday its experimental drug failed to meet the main goal of a mid-to-late stage trial involving patients with amyotrophic lateral sclerosis (ALS), a fatal neurodegenerative disease.

Shares of the drug developer were down 6.6% in extended trade following the announcement.

The study’s main goal was to demonstrate a change in disease severity over time and increase survival, comparing DNL343 to a placebo, as measured by a specific scale.

“We remain deeply committed to fully understanding the effects of DNL343 in ALS and will further evaluate the data before determining next steps”, said Merit Cudkowicz, the study’s principal investigator.

A more comprehensive analysis of the study results will become available later in 2025, according to Carole Ho, the company’s medical chief.

(Reporting by Puyaan Singh in Bengaluru; Editing by Tasim Zahid)