MedPath

DNL343

Generic Name
DNL343
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
-
CAS Number
2278265-85-1
Unique Ingredient Identifier
-
Background

DNL343 is under investigation in clinical trial NCT05842941 (HEALEY ALS Platform Trial - Regimen G DNL343).

Associated Conditions
-
Associated Therapies
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Denali Therapeutics Announces Topline Results for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform Trial

DNL343, evaluated in the HEALEY ALS Platform Trial, did not meet primary or secondary endpoints at 24 weeks but was safe and well-tolerated. Further analyses, including biomarkers and subgroup data, are expected in 2025. The study underscores the urgent need for effective ALS treatments.
stocktitan.net
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Denali Therapeutics ALS Drug Trial Falls Short as DNL343 Misses Primary Endpoint

Denali Therapeutics announced topline results from the Phase 2/3 HEALEY ALS Platform Trial for DNL343, showing it did not meet the primary endpoint of slowing ALS progression compared to placebo. The trial involved 325 participants, with DNL343 found safe and well-tolerated. Further analyses are expected in 2025.
finance.yahoo.com
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Denali Therapeutics Announces Topline Results for DNL343 in Phase 2/3 HEALEY ALS Platform Trial

Denali Therapeutics announced DNL343 did not meet primary and secondary endpoints in the Phase 2/3 HEALEY ALS Platform Trial for ALS treatment. Despite not showing efficacy in slowing disease progression, DNL343 was safe and well-tolerated. Further analyses, including biomarker studies, are expected in 2025.
investing.com
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Denali Therapeutics' ALS study fails to meet primary endpoint

Denali Therapeutics' stock fell 19% after its ALS study with DNL343 failed to meet primary and secondary objectives, despite being safe and well tolerated. Further analyses are planned for 2025.
investing.com
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Denali reports ALS trial misses primary goals

Denali Therapeutics Inc. announced its Phase 2/3 clinical trial for ALS treatment DNL343 did not meet primary efficacy endpoints. Despite this, DNL343 was safe and well tolerated. The company, financially robust, plans further analyses. ALS affects 30,000 in the U.S. and 500,000 globally. Denali remains committed to ALS treatment research.
massgeneral.org
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Sean M. Healey & AMG Center Announces Topline Results of HEALEY ALS Platform Trial's Regimen G Testing DNL343

The HEALEY ALS Platform Trial's Regimen G, testing DNL343, did not meet primary or key secondary endpoints at 24 weeks but was safe and well-tolerated. Additional analyses, including biomarkers and long-term effects, are expected by 2025. The trial aims to accelerate ALS treatment development, with ongoing commitment to understanding DNL343's effects.
morningstar.com
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Denali Therapeutics Announces Topline Results for Regimen G Evaluating DNL343 in the HEALEY ALS Platform Trial

DNL343, evaluated in the Phase 2/3 HEALEY ALS Platform Trial, did not meet primary or key secondary endpoints at 24 weeks but was safe and well-tolerated. Further analyses, including biomarker studies, are expected in 2025. The trial aims to accelerate ALS treatment development.
marketscreener.com
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Denali Therapeutics Announces Topline Results for Regimen in HEALEY ALS Platform Trial

DNL343, evaluated in the Phase 2/3 HEALEY ALS Platform Trial, did not meet primary and key secondary endpoints at 24 weeks but was safe and well-tolerated. Further analyses, including biomarkers and subgroup data, are expected in 2025. ALS, affecting 30,000 in the U.S., urgently needs effective therapies.

Faroe Islands Archives: Sickle Cell Disease Impact, J&J NSCLC Trial, BIAL Parkinson’s Study, Acelyrin Stock Drop, Metsera GLP-1RA Results, Lyme Disease Trial Exclusion, Denali ALS Therapy Failure, FDA Skin Biopsy Guidance, CytoMed and SunAct Solid Tumour Trial, I-Mab CD73 Antibody Pause

Sickle cell disease impacts health severely. J&J reports positive Phase III NSCLC trial results. BIAL completes full dose regimen in Parkinson’s trial. Acelyrin's stock drops despite positive Phase II data. Metsera announces positive Phase IIa GLP-1RA results. Study finds Lyme disease patients excluded by trial criteria. Denali's ALS therapy fails Phase II/III. FDA issues draft guidance on skin biopsies. CytoMed and SunAct to trial solid tumour treatment. I-Mab pauses CD73 antibody development.
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