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 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’ 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.
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.
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).
ALS drug fails stage 3 trial
Secondary endpoints, including the revised ALS functioning rating scale, respiratory function and health-related quality of life also showed no statistically significant improvement compared to the placebo.
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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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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 ...
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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, ...
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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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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 ...
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Denali Therapeutics price target lowered to $32 from $35 at BTIG
BTIG analyst Thomas Shrader lowered the firm’s price target on Denali Therapeutics (DNLI) to $32 from $35 and keeps a Buy rating on the shares after the company announced topline data from the Phase 2 ...
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Denali Starts Dosing in Phase II Parkinson's Disease Study
Denali has two wholly-owned, late-stage development programs, DNL310 for Hunter syndrome and DNL343 (eIF2B activator) for amyotrophic lateral sclerosis (ALS). DNL310 or tividenofusp alfa is an ...