Denali Therapeutics Inc. (DNLI) News
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Latest DNLI News From Around the Web
Below are the latest news stories about DENALI THERAPEUTICS INC that investors may wish to consider to help them evaluate DNLI as an investment opportunity.
DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy DesignationDenali obtains Breakthrough Therapy Designation for its experimental candidate, tividenofusp alfa (DNL310), for the treatment of pateints with Hunter syndrome. |
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)Denali expects to submit a Biologics License Application for tividenofusp alfa in early 2025 for regulatory review under the accelerated approval pathwaySOUTH SAN FRANCISCO, Calif., Jan. 08, 2025 (GLOBE NEWSWIRE) -- 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 of individuals with Hunter syndrome (MPS II). This designation is in addition to Fas |
Denali Therapeutics price target lowered to $32 from $35 at BTIGBTIG analyst Thomas Shrader lowered the firm’s price target on Denali Therapeutics (DNLI) to $32 from $35 and keeps a Buy rating on the shares after the company announced topline data from the Phase 2/3 HEALEY trial which was testing an agonist of eIF2B for amyotrophic lateral sclerosis. The DNL343 failure is sobering as the program was backed by convincing pre-clinical data showing reduced aggregation of key drivers of ALS pathology such as TDP-43, the analyst tells investors in a research note |
These Stocks Moved the Most Today: Nvidia, Micron, Aurora Innovation, Tesla, Carvana, Moderna, Palantir, and MoreNvidia falls after the company provides few updates about its artificial-intelligence chips at the CES trade show, while shares of Micron and Aurora Innovation jump after securing partnerships with the semiconductor giant. |
Denali Reverses Its Fortunes With 'Too Early' Miss In ALS TreatmentDenali Therapeutics shares reversed higher on Tuesday after the drugmaker's ALS treatment failed in a six-month study. |
Denali's ALS Study Fails to Meet Primary and Secondary EndpointsDNLI's DNL343 fails to achieve the primary and secondary endpoints, as observed from an analysis of Regimen G of the phase II/III HEALEY ALS platform trial. |
Denali Therapeutics' Amyotrophic Lateral Sclerosis Misses Pivotal Trial, But Analyst Says It Was ExpectedOn Monday, Denali Therapeutics Inc. (NASDAQ:DNLI) revealed topline results from an analysis of Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating DNL343 for amyotrophic lateral sclerosis. Compared to placebo, the study did not meet the primary endpoint of efficacy in slowing disease progression. The primary endpoint was evaluated as a change in disease severity over time as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) and survival through week 24. Also Read: Denali |
Denali Therapeutics’ ALS therapy fails to meet primary endpoint in Phase II/III trialThe primary analysis included 186 subjects who received the therapy and 139 subjects who were given a placebo. |
Denali Therapeutics Announces Topline Results for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform TrialPrimary endpoint of overall function (ALSFRS-R) and survival, and key secondary endpoints of muscle strength and respiratory function, were not met at 24 weeksOverall, DNL343 was found to be safe and well toleratedAdditional analyses, including neurofilament light (NfL) and other fluid biomarkers, prespecified sub-group analyses and analyses from the active treatment extension period are expected later in 2025 SOUTH SAN FRANCISCO, Calif., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc |
Denali Therapeutics Neurodegenerative Disease Platform Sparks Analyst OptimisticWilliam Blair has initiated coverage on Denali Therapeutics Inc (NASDAQ:DNLI), a company focused on developing drugs for neurodegenerative diseases. The analyst highlights that Denali is developing a specialized transport vehicle (TV) platform to enhance the delivery of treatments across the blood-brain barrier. It stands out from competitors with its promising potential for top-tier performance and scalability across different therapies and conditions. The company’s lead program Tividenofusp al |