Denali Therapeutics Inc.'s DNL343 failed to meet the primary endpoint in the phase 2/3 HEALY ALS trial, but potential biomarker analyses in 2025 may offer a path forward. Despite the trial setback in ALS, Denali's stock remains stable due to continued pre-specified analyses expected in late 2025. BLA filing of tividenofusp alfa for the treatment of patients with MPS II remains on track under th...
Denali Therapeutics shares reversed higher on Tuesday after the drugmaker's ALS treatment failed in a six-month study. The post Denali Reverses Its Fortunes With 'Too Early' Miss In ALS Treatment appeared first on Investor's Business Daily.
Denali Therapeutics said on Monday its experimental drug failed to meet the main goal of a mid-to-late stage trial in patients with amyotrophic lateral sclerosis (ALS), a fatal neurodegenerative disease.
SOUTH SAN FRANCISCO, Calif., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI) today announced topline results from an analysis of Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating eIF2B agonist DNL343 in the treatment of amyotrophic lateral sclerosis (ALS).
Denali Therapeutics' unique blood-brain barrier technology and strategic partnerships offer a significant edge in the challenging neurodegenerative disease landscape. The company's strong cash position and disciplined financial strategy support its ambitious R&D and commercialization efforts without immediate need for additional funding. Denali's pipeline targets critical neurodegenerative path...
SOUTH SAN FRANCISCO, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the third quarter ended September 30, 2024, and provided business highlights.
SOUTH SAN FRANCISCO, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced the outcome of a recent successful meeting with the Center for Drug Evaluation and Research (CDER) division of the U.S. Food and Drug Administration (FDA) providing a path to filing a biologics license application (BLA) for accelerated approval and subsequent conversion to ful...
Denali Therapeutics' proprietary Transport Vehicle technology enables drug delivery across the blood-brain barrier, targeting neurodegenerative diseases. DNL310, targeting MPS II, and DNL343 for ALS are key drug candidates with potential, though competition is significant. The company's $500 million capital raise supports its aggressive R&D investment, providing a runway for developing its pipe...
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