HEALEY ALS Trial Serves Up More Disappointment as Denali, AbbVie/Calico Fail
Misses from amyotrophic lateral sclerosis hopefuls Denali Therapeutics and partners AbbVie and Calico Life Sciences mark the latest setbacks for the controversial platform trial, the results from which have largely mirrored the dismal success rate in the ALS space overall.
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: Despite ALS Primary Endpoint Failure, Possible Path Forward Remains
Denali Therapeutics Inc.'s stock remains stable despite trial setback in ALS. BLA filing for MPS II treatment on track. Click for my DNLI stock update.
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 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.
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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Denali Therapeutics spinout raises $200M as neuro company resets
Tenvie Therapeutics is making hay from an R&D shift at Denali Therapeutics, acquiring several of its neuroscience drug ...
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Denali Therapeutics Ratchets Up Losses On Misstep In ALS Treatment. Why The Game Isn't Over Yet.
Denali Therapeutics shares slumped for the second straight day Tuesday after the drugmaker's ALS treatment failed in a ...
GMC Celebrates 25 Years Of The Denali
To commemorate the 25th anniversary of Denali, GMC is offering customers a special 25th Anniversary Denali Package available ...
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 ...
Denali Therapeutics: Strategic Pipeline Potential and Investment Opportunity Amid Recent Setbacks
Analyst Mayank Mamtani from B.Riley Financial reiterated a Buy rating on Denali Therapeutics (DNLI – Research Report) and keeping the price ...
Trump Proposes Renaming Mount Denali to Mount McKinley, Sparking Cultural Debate
President-elect Donald Trump has announced plans to change the name of Mount Denali in Alaska back to Mount McKinley, ...
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Denali Fault Mystery Unveiled: A Geological Breakthrough Reshapes North America’s History
A 620-mile geological enigma that has baffled scientists for decades has finally been solved. The Denali Fault, a massive ...
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)
Denali Therapeutics Inc. (NASDAQ: DNLI), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tividenofusp alfa (DNL310) for the treatment ...