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.
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.
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 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 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.
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 (NASDAQ:DNLI) Earns Outperform Rating from Analysts at Robert W. Baird
Robert W. Baird assumed coverage on shares of Denali Therapeutics (NASDAQ:DNLI – Free Report) in a research note released on ...
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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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Arch-backed Tenvie unveils with $200M and a neuro pipeline with assets from Denali
Tenvie Therapeutics has unveiled with $200 million and the goal of transforming the neurological treatment landscape, nabbing ...
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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 ...
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 ...
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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 ...
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 ...
Why biotech startup Tenvie sees promise in drugs from founders' old company
About a year ago, Tenvie President and Chief Scientific Officer Tony Estrada approached Denali CEO Ryan Watts and others in ...