NASDAQ:DNLI - Nasdaq - US24823R1059 - Common Stock - Currency: USD
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.
SOUTH SAN FRANCISCO, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the first...
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 showcases its BBB platform at J.P. Morgan Conference, highlighting DNL310's Hunter syndrome progress and plans for commercialization.
Mentions: JPM
Rolling submission of BLA initiated for tividenofusp alfa; preparations ongoing for potential U.S. commercial launch in late 2025 or early 2026Alignment...
SOUTH SAN FRANCISCO, Calif., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the fourth...
InvestorPlace - Stock Market News, Stock Advice & Trading Tips Denali Therapeutics (NASDAQ:DNLI) just reported results for the second quarter ...
Long-term data demonstrate that robust reductions and normalization in key biomarkers from baseline were maintained over time with continued improvement in...
Denali expects to submit a Biologics License Application for tividenofusp alfa in early 2025 for regulatory review under the accelerated approval pathway...
Denali expects to submit a Biologics License Application for tividenofusp alfa in early 2025 for regulatory review under the accelerated approval pathway
One analyst says the six-month study was too short and the benefits could appear over time.
Primary endpoint of overall function (ALSFRS-R) and survival, and key secondary endpoints of muscle strength and respiratory function, were not met at 24...
SOUTH SAN FRANCISCO, Calif., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced initiation of dosing in a global...
SOUTH SAN FRANCISCO, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the third...
Recent successful meeting with the FDA provides path to file for accelerated approval and subsequent conversion to full approvalPlan to submit biologics...
SOUTH SAN FRANCISCO, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad...