Denali Therapeutics Inc. (DNLI) announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, tividenofusp alfa (DNL310), for the treatment of individuals with Hunter syndrome (MPS II).Denali’s wholly owned program, DNL310 or tividenofusp alfa, is an Enzyme Transport Vehicle-enabled iduronate-2-sulfatase (IDS) replacement therapy in development for MPS II (Hunter syndrome).Shares of DNLI have lost 1.9% in the past six months compared with the industry’s 8.3% decline.Image So ...

SOUTH 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 Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation, all previously granted by the FDA for tividenofusp alfa in Hunter syndrome. Dena ...

Core Findings - Denali Therapeutics Inc (DNLI) announced disappointing top-line results from the phase II/III HEALEY ALS Platform Trial for its pipeline candidate DNL343, which failed to meet the primary endpoint of slowing disease progression compared to placebo [1][3][4] - DNL343, a novel small molecule targeting eIF2B, was well tolerated but did not show statistically significant differences in key secondary endpoints measuring muscle strength and respiratory function at week 24 [4][5] - The HEALEY ALS Platform Trial involved 186 participants receiving DNL343 and 139 receiving placebo, with ALS affecting approximately 30,000 people in the US and 500,000 worldwide [3] Stock Performance - DNLI shares declined 6.5% over the past six months, slightly underperforming the industry's 6.4% decline [2] Pipeline Updates - Denali and partner Sanofi discontinued the development of SAR443820/DNL788 for multiple sclerosis after the phase II K2 study failed to meet primary and key secondary endpoints [6][8] - The companies are co-developing SAR443122/DNL758 (eclitasertib) for ulcerative colitis, currently in phase II studies [8] - Denali's wholly owned program, DNL310 (tividenofusp alfa), is in development for MPS II (Hunter syndrome) [9] - BIIB122 (DNL151), an LRRK2 inhibitor for Parkinson's disease, is being evaluated in a global phase IIa study (BEACON) and a phase IIb study (LUMA) in collaboration with Biogen [9][10][11] Future Plans - Denali will report additional data from the HEALEY ALS Platform Trial in 2025, including neurofilament light (NfL) and other fluid biomarkers, subgroup analyses, and extended findings from the active treatment extension period [5] - The company will evaluate the data before determining next steps for DNL343 [5] Industry Comparison - Immunocore Holdings plc (IMCR), a Zacks Rank 1 (Strong Buy) stock in the biotech sector, has seen narrowing loss per share estimates for 2024 and 2025, with an average earnings surprise of 25.57% in the trailing four quarters [12][13]

Primary 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. (NASDAQ:DN ...

William Blair has initiated coverage on Denali Therapeutics Inc 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 alfa, an enzyme-replacemen ...

Denali Therapeutics (NASDAQ: NASDAQ: DNLI ) is changing the neurodegenerative disease landscape - one traditionally characterized by failed trials and a grim outlook. While almost all investors remain focused on large pharmaceutical players or are wary because of past disappointmentsI have a strong inclination towards high-growth companies, often treading in sectors poised for exponential expansion. My expertise lies in understanding and investing in disruptive technologies and forward-thinking enterprises. ...

Shares of Denali Therapeutics (DNLI) rose marginally yesterday after the company reported third-quarter results on Wednesday.Denali incurred a third-quarter 2024 loss of 63 cents per share, wider than the Zacks Consensus Estimate of a loss of 60 cents. The company reported a loss of 72 cents in the year-ago quarter.The bottom line improved year over year despite a rise in operating expenses, mainly due to an increase in the number of shares outstanding.In the absence of a marketed product, the company only ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38311 Denali Therapeutics Inc. (Exact name of registrant as specified in its charter) Delaware 46-3872213 ...

Exhibit 99.1 Denali Therapeutics Reports Third Quarter 2024 Financial Results and Business Highlights SOUTH SAN FRANCISCO, Calif., – November 6, 2024 – Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the third quarter ended September 30, 2024, and provided business highlights. "As leaders in pioneering a new class of therapeutics that cross the blood-brain barrier, we are making significant progress across our Transport Vehicle (TV)-enabled portfolio," said Ryan Watts, Ph.D., Ch ...

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. "As leaders in pioneering a new class of therapeutics that cross the blood-brain barrier, we are making significant progress across our Transport Vehicle (TV)-enabled portfolio,” said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. “Within our Enzyme TV (ETV) franchise, we a ...