Denali Therapeutics

Denali Therapeutics Inc. director Vicki L. Sato sold 3,080 shares at $20.91 each, totaling $64,402.80, reducing her stake by 2.77%. DNLI stock opened at $21.26, with a market cap of $3.06 billion. Institutional investors increased stakes, owning 92.92% of shares. Analysts rate DNLI as 'Moderate Buy' with a $40.40 average target. Denali develops treatments for neurodegenerative and lysosomal storage diseases.

DNL343, evaluated in the HEALEY ALS Platform Trial, did not meet primary or key secondary endpoints at 24 weeks but was safe and well-tolerated. Further analyses, including biomarkers and subgroup data, are expected in 2025. The study underscores the urgent need for effective ALS treatments.

Denali Therapeutics Inc. announced FDA Breakthrough Therapy Designation for tividenofusp alfa (DNL310) for Hunter syndrome treatment, highlighting its potential to address both brain and body symptoms. The designation aims to expedite development, with a Biologics License Application expected in early 2025. Tividenofusp alfa targets the disease's cognitive, behavioral, and physical symptoms, representing a significant advancement over current treatments.

Denali Therapeutics Inc. DNLI started dosing in the BEACON study for BIIB122, targeting LRRK2-associated Parkinson’s disease. Shares rose 8.7% YTD. The phase IIa study assesses BIIB122's safety and biomarkers in 50 participants, funded by a $75M agreement. Denali also progresses with DNL310 for Hunter syndrome and DNL343 for ALS, planning a BLA for DNL310.

DelveInsight's 'Multiple Sclerosis Pipeline Insight 2024' report highlights 75+ companies developing 80+ therapies, including promising candidates like GA Depot, Remibrutinib, and IMU 838. Key events include Immunic's positive Phase 3 ENSURE trial interim analysis, Roche's FDA approval for Ocrevus injectable, and Sanofi's mixed results for tolebrutinib in Phase III trials. The report covers global pipeline stages, product types, molecule types, mechanisms of action, and routes of administration.

Tau Inhibitors Clinical Trial Pipeline Analysis shows 25+ key companies expected to transform treatment, with increased funding accelerating advancements in neurodegenerative disease therapies.

Denali Therapeutics Inc. (DNLI), a biopharmaceutical company, focuses on developing treatments for neurodegenerative and lysosomal storage diseases. With a market cap of $3.058B, it collaborates with major firms like Biogen and Takeda. Its programs target diseases such as Parkinson's, ALS, and MPS, utilizing innovative transport vehicle technology.

Denali Therapeutics plans to submit a biologics license application (BLA) for tividenofusp alfa (DNL310) under the accelerated approval pathway in early 2025, following a successful FDA meeting. Phase 1/2 data presented at SSIEM 2024 shows significant biomarker responses and clinical improvements in MPS II patients, supporting the drug's potential for accelerated and full approval.

Denali Therapeutics plans to submit a biologics license application (BLA) for tividenofusp alfa (DNL310) under the accelerated approval pathway in early 2025, following a successful FDA meeting. Phase 1/2 data presented at SSIEM 2024 shows robust biomarker responses and clinical improvements in MPS II (Hunter syndrome) treatment, supporting the drug's potential for accelerated and full approval.