DENALI THERAPEUTICS INC (DNLI) Stock News
NASDAQ:DNLI - Nasdaq - US24823R1059 - Common Stock - Currency: USD
DNLI Latest News, Press Relases and Analysis
Why Is Denali Therapeutics (DNLI) Up 0.7% Since Last Earnings Report?
Denali Therapeutics (DNLI) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Mentions: MRNA
Denali Q1 Loss Wider Than Expected, Hunter Syndrome Drug in Focus
DNLI reports a wider-than-expected loss for the first quarter of 2025. Denali submits a BLA for tividenofusp alfa under the FDA???s accelerated approval pathway based on data from the phase I/II study in participants with Hunter syndrome.
Denali Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights Including Completion of BLA Rolling Submission for Tividenofusp Alfa for Hunter Syndrome
SOUTH SAN FRANCISCO, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the first...
Why Is Denali Therapeutics Stock Trading Higher On Wednesday?
Denali Therapeutics showcases its BBB platform at J.P. Morgan Conference, highlighting DNL310's Hunter syndrome progress and plans for commercialization.
Mentions: JPM
What Happened To Denali Therapeutics Stock Wednesday?
Denali Therapeutics, Inc. (NASDAQ:DNLI) shares traded higher on Wednesday after the company initiated its biologics license application (BLA) for the accelerated approval of Tividenofusp Alfa for the treatment of Hunter syndrome.
Denali Therapeutics Announces Initiation of BLA Filing for Accelerated Approval of Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II) and Positive Ongoing Interactions with FDA on DNL126 Through START Program
Rolling submission of BLA initiated for tividenofusp alfa; preparations ongoing for potential U.S. commercial launch in late 2025 or early 2026Alignment...
Denali Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights
SOUTH SAN FRANCISCO, Calif., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the fourth...
Denali Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights
Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) with Tividenofusp Alfa
Long-term data demonstrate that robust reductions and normalization in key biomarkers from baseline were maintained over time with continued improvement in...
Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) with Tividenofusp Alfa
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 pathway...
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 pathway
Denali Therapeutics Ratchets Up Losses On Misstep In ALS Treatment. Why The Game Isn't Over Yet.
One analyst says the six-month study was too short and the benefits could appear over time.
Denali Therapeutics Announces Topline Results for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform Trial
Primary endpoint of overall function (ALSFRS-R) and survival, and key secondary endpoints of muscle strength and respiratory function, were not met at 24...
Denali Therapeutics Announces Topline Results for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform Trial
Denali Therapeutics Announces First Participant Dosed in Phase 2a Study of LRRK2 Inhibitor, BIIB122, in LRRK2-Associated Parkinson’s Disease
SOUTH SAN FRANCISCO, Calif., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced initiation of dosing in a global...
Denali Therapeutics Announces First Participant Dosed in Phase 2a Study of LRRK2 Inhibitor, BIIB122, in LRRK2-Associated Parkinson’s Disease
Denali Therapeutics Reports Third Quarter 2024 Financial Results and Business Highlights
SOUTH SAN FRANCISCO, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the third...
Denali Therapeutics Reports Third Quarter 2024 Financial Results and Business Highlights
Denali Therapeutics Announces Successful Meeting with the FDA and Plans to File for Accelerated Approval of Tividenofusp Alfa (DNL310) for the Treatment of MPS II (Hunter Syndrome)
Recent successful meeting with the FDA provides path to file for accelerated approval and subsequent conversion to full approvalPlan to submit biologics...
Denali Therapeutics Announces Publication in Science Translational Medicine Demonstrating the Potential of the Oligonucleotide Transport Vehicle Platform to Achieve Broad Biodistribution of Antisense Oligonucleotides in the CNS and Muscle Following
SOUTH SAN FRANCISCO, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad...