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Denali Therapeutics Inc. - DNLI STOCK NEWS

Welcome to our dedicated page for Denali Therapeutics news (Ticker: DNLI), a resource for investors and traders seeking the latest updates and insights on Denali Therapeutics stock.

Denali Therapeutics Inc. (NASDAQ: DNLI) is a leading biotechnology company based in South San Francisco, focused on the discovery and development of breakthrough therapies for neurodegenerative diseases such as Alzheimer’s, Parkinson’s, and ALS, as well as lysosomal storage diseases like MPS II (Hunter syndrome) and MPS IIIA (Sanfilippo syndrome Type A).

Founded by a visionary team of scientists, industry experts, and investors, Denali leverages cutting-edge genetic insights and translational medicine tools to address the underlying causes of neurodegeneration. The company is pioneering the use of its proprietary Transport Vehicle (TV) technology, designed to deliver large therapeutic molecules across the blood-brain barrier (BBB) effectively.

Denali’s development pipeline includes several promising programs:

  • Tividenofusp alfa (DNL310): An ETV-enabled iduronate-2-sulfatase (IDS) replacement therapy in late-stage development for MPS II.
  • DNL343: An eIF2B activator targeting ALS, currently in the Phase 2/3 HEALEY ALS Platform Trial.
  • DNL126 (ETV:SGSH): An enzyme replacement therapy for MPS IIIA, selected by the FDA for the START Pilot Program to accelerate rare disease therapeutic development.
  • OTV:MAPT: Aiming to treat Alzheimer’s disease by targeting tau proteins.
  • BIIB122/DNL151: A LRRK2 inhibitor co-developed with Biogen for Parkinson’s disease.

Denali’s rigorous scientific approach has garnered significant collaborations with industry giants like Sanofi, Takeda, and Biogen, enhancing its potential to revolutionize treatment for these debilitating disorders. Financially, Denali is robust, with over $1.43 billion in cash and marketable securities as of March 31, 2024, and a projected cash runway extending into 2028.

Denali’s latest news includes the initiation of clinical trials for DNL126 and the announcement of program milestones expected to make significant strides in 2024. For more details, visit Denali Therapeutics.

Rhea-AI Summary
Denali Therapeutics Inc. announces new data presentations highlighting the potential of its BBB-crossing enzyme replacement therapies in development for the treatment of mucopolysaccharidoses (MPS). New clinical data on tividenofusp alfa in MPS II (Hunter syndrome) and mouse model data on DNL126 in MPS IIIA (Sanfilippo syndrome type A) are being presented. The Phase 1/2 study of tividenofusp alfa shows sustained normalization of CSF heparan sulfate, robust, sustained reduction in neurofilament light chain (NfL), and positive treatment effects in brain and somatic tissues. The Phase 1/2 results also demonstrate normalization of liver and spleen volumes, maintenance of normal growth, and sustained reduction of urine heparan sulfate and dermatan sulfate. Dosing has begun in the Phase 1/2 study of DNL126 for the potential treatment of MPS IIIA.
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Denali Therapeutics Inc. (Nasdaq: DNLI) announced upcoming presentations at the 20th Annual WORLDSymposium™ for its Enzyme Transport Vehicle (ETV) development programs, tividenofusp alfa (DNL310) and DNL126 (ETV:SGSH). The presentations will include new two-year data on clinical outcomes and preclinical studies of DNL126 in MPS IIIA mice. Denali is also participating in events on strategies for treating the CNS and emerging biomarkers in neurodegenerative lysosomal diseases.
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Denali Therapeutics Inc. (DNLI) announced program progress and expected milestones for 2024, including the completion of enrollment in late-stage clinical trials for MPS II and ALS, establishment of commercial readiness, and advancement of a broad clinical-stage portfolio of seven therapeutic product candidates across various diseases.
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Denali Therapeutics Inc. (DNLI) Reports Q3 Financial Results, Highlights Progress in Neurodegenerative Disease Treatment
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Denali Therapeutics announces positive interim data from Phase 1/2 study of DNL310 in MPS II patients
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Denali Therapeutics Inc. (DNLI) and Biogen Inc. have entered a significant collaboration with Biogen exercising its option to license Denali's Antibody Transport Vehicle (ATV):Amyloid beta program (ATV:Aβ) aimed at Alzheimer’s treatment.

The ATV technology is designed to enhance the delivery of therapeutic antibodies across the blood-brain barrier, potentially improving efficacy against amyloid beta plaque, a key feature of Alzheimer’s disease. Following this agreement, Biogen will manage all development and commercialization efforts related to the program, while Denali will receive an option exercise payment and may earn milestone payments and royalties based on future sales. This collaboration builds on the partnership initiated in 2020.

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FAQ

What is the current stock price of Denali Therapeutics (DNLI)?

The current stock price of Denali Therapeutics (DNLI) is $21.45 as of December 20, 2024.

What is the market cap of Denali Therapeutics (DNLI)?

The market cap of Denali Therapeutics (DNLI) is approximately 3.1B.

What is Denali Therapeutics Inc. known for?

Denali Therapeutics Inc. is known for developing therapies targeting neurodegenerative diseases and lysosomal storage diseases using its proprietary Transport Vehicle (TV) technology.

What are some key products in Denali's pipeline?

Key products include Tividenofusp alfa (DNL310) for MPS II, DNL343 for ALS, DNL126 for MPS IIIA, and BIIB122/DNL151 for Parkinson’s disease.

What is Denali’s Transport Vehicle (TV) technology?

Denali’s TV technology is designed to deliver large therapeutic molecules across the blood-brain barrier, improving treatment efficacy for central nervous system diseases.

Who are some of Denali’s key partners?

Denali has significant collaborations with Sanofi, Takeda, and Biogen.

What is the financial outlook for Denali Therapeutics?

Denali has a strong financial position with over $1.43 billion in cash and marketable securities, and a cash runway extending into 2028.

What recent milestones has Denali achieved?

Recent milestones include FDA selection of DNL126 for the START Pilot Program and the initiation of clinical trials for MPS IIIA and ALS therapies.

Where is Denali Therapeutics headquartered?

Denali Therapeutics is headquartered in South San Francisco, California.

What diseases does Denali focus on?

Denali focuses on neurodegenerative diseases such as Alzheimer’s, Parkinson’s, ALS, and lysosomal storage diseases like MPS II and MPS IIIA.

How does Denali's TV technology work?

Denali's TV technology uses engineered Fc domains to bind specific transport receptors at the BBB, delivering therapeutic cargo to the brain through receptor-mediated transcytosis.

What is the significance of Denali’s collaborations?

Collaborations with companies like Sanofi, Takeda, and Biogen enhance Denali’s capacity to develop and commercialize groundbreaking therapeutics for neurodegenerative diseases.

Denali Therapeutics Inc.

Nasdaq:DNLI

DNLI Rankings

DNLI Stock Data

3.09B
130.05M
9.66%
91.47%
4.93%
Biotechnology
Biological Products, (no Disgnostic Substances)
Link
United States of America
SOUTH SAN FRANCISCO