Denali Therapeutics Inc. Stock News

SOUTH SAN FRANCISCO, Calif., April 02, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), today announced that the company's initiation of a rolling submission of a biologics license application (BLA) for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome (MPS II) has been received by the Center for Drug Evaluation and Research (CDER) of the U.S. Food ...

Denali Therapeutics' stock has significantly dropped from $100 to $15 since 2021, but the company is now heavily derisked with promising product candidates nearing key milestones. Lead asset DNL310 shows strong biomarker data for Hunter syndrome, with plans for a BLA submission and accelerated approval by Q2 2025. The Biogen partnership for Parkinson's Disease asset DNL151 includes substantial ...

SOUTH SAN FRANCISCO, Calif., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the fourth quarter and year ended December 31, 2024, and provided business highlights.

SOUTH SAN FRANCISCO, Calif., Feb. 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), today announced the primary analysis of the Phase 1/2 study in 47 participants with Hunter syndrome (MPS II) in the 24-week treatment period and additional long-term follow-up of its investigational therapeutic tividenofusp alfa (DNL310). These data, along with recent Breakthrough Therapy des...

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).