ALS, Denali

Denali Therapeutics’ ALS drug fails to improve function and survival in phase 2/3 trial
Denali Therapeutics' DNL343 fails to slow ALS progression in phase 2/3 trial but shows safety and offers insights for future analysis.
Denali Therapeutics’ ALS therapy fails to meet primary endpoint in Phase II/III trial
The primary analysis included 186 subjects who received the therapy and 139 subjects who were given a placebo.
ALS drugs from Denali, Calico come up short, marking setback for Healey trial
Denali’s medicine and a similar one from Calico Life Sciences and AbbVie were not much different than a placebo, bringing the tally of failed drugs in the innovative “Healey platform trial” to seven.
Denali's ALS Study Fails to Meet Primary and Secondary Endpoints
Denali Therapeutics Inc. DNLI announced disappointing top-line results from an analysis of Regimen G of the phase II/III HEALEY ALS Platform Trial on pipeline candidate DNL343. The HEALEY platform trial is evaluating eIF2B agonist DNL343 in the treatment of amyotrophic lateral sclerosis (ALS).
Denali Therapeutics announces HEALEY ALS trial regimen misses endpoints
Denali Therapeutics (DNLI) announced topline results from an analysis of Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating eIF2B
ALS drug by Google's anti-aging subsidiary fails clinical trial
Calico, Google's anti-aging subsidiary, has announced disappointing results from its first-ever drug trial. The experimental drug, fosigotifator, was tested as a potential treatment for amyotrophic lateral sclerosis (ALS).
Google's ALS drug fails phase 3 trial
A clinical trial evaluating the drug fosigotifator in patients with amyotrophic lateral sclerosis has failed to meet its primary endpoint, according to topline results from the Healey ALS platform trial.
Denali Therapeutics Announces Topline Results for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform Trial
Primary endpoint of overall function (ALSFRS-R) and survival, and key secondary endpoints of muscle strength and respiratory function, were not
Denali Therapeutics' ALS drug fails in mid-to-late stage trial
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.
Denali Therapeutics Says ALS Trial Didn't Meet Endpoints
Denali Therapeutics said the latest trial of its treatment for amyotrophic lateral sclerosis, or ALS, didn't meet its primary or secondary endpoints after 24 weeks. The biotechnology company said Monday that DNL343 didn't meet the primary endpoint of slowing disease progression as compared with a placebo.
ALS News Today6h
DNL343, fosigotifator fail HEALEY platform trial’s main goal in ALS
DNL343 and fosigotifator are made to activate the ISR pathway protein eIF2B, but both failed to slow ALS progression in the HEALEY trial.
Morningstar22d
Neurizon Files IND Application to Support HEALEY ALS Platform Trial
This milestone is a pivotal step in enabling the commencement of a Phase 2/3 clinical trial within the HEALEY ALS Platform Trial framework. The FDA has a period of 30 days to review the IND ...
FierceBiotech2d
Rival AbbVie and Denali prospects flunk phase 2/3 ALS tests, denting hopes for shared mechanism
AbbVie, Calico and Denali Therapeutics’ hopes of treating amyotrophic lateral sclerosis (ALS) by targeting eIF2B have all ...
Crain's Chicago Business1d
AbbVie and rival's ALS drugs both disappoint in study
In studies by Massachusetts General Hospital, the AbbVie-Calico collaborative drug and Denali Therapeutics' own drug failed to meet endpoints for treating amyotrophic lateral sclerosis, more widely ...