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.
Novel small molecule for ALS fails to meet primary endpoint in phase 2/3 study
Topline results from a phase 2/3 clinical trial showed that an eIF2B agonist to treat ALS failed to meet its primary endpoint of slowing disease progression compared with placebo at week 24.According to a press release from Denali Therapeutics Inc.
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 Suffers Another ALS Fail With Phase II/III Flop
Denali’s failure on Monday continues biopharma’s losing streak against amyotrophic lateral sclerosis. PTC Therapeutics and Amylyx have seen similarly disappointing results.
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 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
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.
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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.
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DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy Designation
Denali Therapeutics Inc. DNLI announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, ...
Denali Therapeutics' Amyotrophic Lateral Sclerosis Misses Pivotal Trial, But Analyst Says It Was Expected
Denali's DNL343 missed efficacy goals in the HEALEY ALS trial but was well-tolerated. Analysts await detailed biomarker data ...
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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 ...
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Tenvie Debuts With Denali Assets, $200M for Neurological, Metabolic Diseases
Backed by ARCH Venture Partners, F-Prime Capital and Mubadala Capital, the new company will develop a pipeline of ...
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Denali slides after ALS drug flunks clinical test
The result is another major disappointment to ALS patients, who have limited drug treatment options at present, particularly ...