Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) For the fiscal year ended December 31, 2024 OR Delaware 46-3872213 (State or other jurisdiction of incorporation or organization) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Comm ...

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. “In 2024, we made significant strides across our portfolio, particularly with our Enzyme Transport Vehicle (ETV) programs, achieving a path to a potential accelerated approval for our lead program in MPS II,” said Ryan Watts, Ph.D., CEO of Denali. “In 2025, we will continue expanding ...

Denali Therapeutics (DNLI) reported primary analysis data from an early to mid-stage study of its pipeline candidate, tividenofusp alfa (DNL310), in 47 patients with Hunter syndrome (MPS II) over a 24-week treatment period, along with additional long-term follow-up data. DNLI’s wholly-owned program, tividenofusp alfa, is an Enzyme Transport Vehicle-enabled iduronate-2-sulfatase replacement therapy in development for MPS II.Per the additional long-term data readout from the phase I/II study, treatment with t ...

Long-term data demonstrate that robust reductions and normalization in key biomarkers from baseline were maintained over time with continued improvement in hearing, cognition and adaptive behaviorLong-term safety data with median follow-up of two years, and out to more than four years, demonstrate that tividenofusp alfa was generally well tolerated Regulatory submission for accelerated approval is planned for early 2025; U.S. launch preparation is ongoing to deliver tividenofusp alfa to families with MPS II ...

SOUTH SAN FRANCISCO, Calif., Jan. 30, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), today announced upcoming oral (platform) and poster presentations at the 21st Annual WORLDSymposium™, which will be held February 3-7, 2025, in San Diego, California. The oral presentation includes clinical results related to its Hunter syndrome (MPS II) investigational therapeutic, tividenofusp alfa (DNL310). Tividenofusp alfa is enabled by the Denali TransportVehicle™ platform, which is designed to effec ...

SOUTH SAN FRANCISCO, Calif., Jan. 30, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), today announced upcoming oral (platform) and poster presentations at the 21st Annual WORLDSymposium™, which will be held February 3-7, 2025, in San Diego, California. The oral presentation includes clinical results related to its Hunter syndrome (MPS II) investigational therapeutic, tividenofusp alfa (DNL310). Tividenofusp alfa is enabled by the Denali TransportVehicle™ platform, which is designed to effe ...

Denali Therapeutics (DNLI) has performed well in the past 12 months amid a volatile market. Shares of the company have gained 26.6% against the industry’s decline of 14.3%. The stock has also outperformed the sector and the S&P 500 Index in this time frame.Denali is developing a broad portfolio of product candidates engineered to cross the blood-brain barrier for the treatment of neurodegenerative and lysosomal storage diseases.  The upward price trajectory can be attributed to positive pipeline updates.DNL ...

Denali Therapeutics Inc DNLI CEO Ryan Watts presented at the J.P. Morgan Healthcare Conference. The presentation primarily focused on the company’s blood-brain-barrier (BBB) crossing platform technology and the pipeline, including tividenofusp alfa (tivi, DNL310) in Hunter syndrome and DNL126 in Sanfilippo syndrome Type A, as well as ATV:Abeta approach in Alzheimer’s disease.Also Read: Denali Therapeutics’ Amyotrophic Lateral Sclerosis Misses Pivotal Trial, But Analyst Says It Was ExpectedJP Morgan notes th ...

FDA Breakthrough Therapy Designation received for tividenofusp alfa for Hunter syndrome (MPS II); on track to submit biologics license application (BLA) in early 2025Preparing for commercial launch of tividenofusp alfa for Hunter syndrome in late 2025 or early 2026Enable accelerated approval pathway for DNL126 for Sanfilippo syndrome Type A (MPS IIIA)Expand and advance portfolio of multiple TransportVehicleTM (TV) enabled programs for delivery of enzyme, oligonucleotide, and antibody therapeutics for rare a ...

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