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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.
Denali Therapeutics announced promising data for DNL343, an investigational treatment for amyotrophic lateral sclerosis (ALS), indicating it is well-tolerated, effective in inhibiting stress response biomarkers, and supports once-daily dosing.
The company plans to initiate the Phase 2/3 HEALEY ALS Platform Trial for DNL343 in mid-2023, following a successful 28-day Phase 1b study involving 29 ALS patients. The upcoming results will be showcased at the American Academy of Neurology annual meeting on April 25, 2023.
DNL343 aims to enhance eIF2B activity, potentially preventing ALS progression by improving protein synthesis and neuronal health. The HEALEY trial is a collaborative effort to test multiple therapies simultaneously to expedite ALS treatment development.
Denali Therapeutics Inc. (Nasdaq: DNLI) reported its financial results for Q4 and full-year 2022, highlighting a strategic focus on late-stage clinical development for various neurodegenerative therapies. The company reported a net loss of $98.7 million for Q4, up from $75.3 million the previous year. Collaboration revenue decreased to $10.3 million in Q4, down from $12.5 million year-over-year, though total revenue for the year rose to $108.5 million. Operating expenses are expected to increase by 25-30% in 2023, driven by R&D investments, despite a cash position of $1.34 billion as of December 31, 2022.
Denali Therapeutics announced positive interim results from the Phase 1/2 study of DNL310 (ETV:IDS) for treating MPS II (Hunter syndrome). Data from 28 participants showed significant improvements in adaptive behavior, cognitive capabilities, and hearing after 49 weeks of treatment. DNL310 normalized cerebrospinal fluid levels of heparan sulfate and improved lysosomal function biomarkers. The safety profile is consistent with standard care, and data support continued enrollment in the upcoming Phase 2/3 COMPASS study. Denali also plans to submit an IND application for its second investigational therapy, DNL126, aimed at MPS IIIA.
Denali Therapeutics Inc. (Nasdaq: DNLI) announced key presentations at the 19th Annual WORLD Symposium from February 22-26, 2023, in Orlando, Florida. The focus will be on DNL310 (ETV:IDS) for treating MPS II (Hunter syndrome) and DNL126 (ETV:SGSH) for MPS IIIA (Sanfilippo syndrome type A). Presentations will cover interim clinical data from the Phase 2/3 COMPASS study and preclinical data for DNL126. DNL310 is being evaluated in a global study to address multiple symptoms of Hunter syndrome, and it has received Fast Track and Priority Medicines designations from regulatory authorities. Both therapies aim to provide critical treatment advancements for patients with neurodegenerative lysosomal storage diseases.
Denali Therapeutics (DNLI) announced a significant milestone as its partner, Sanofi, has begun dosing in a Phase 2 clinical trial of SAR443820 (DNL788) for multiple sclerosis. This trial follows the successful Phase 1 trial, which showed robust target engagement and CNS penetration. Denali will receive a $25 million milestone payment from Sanofi for the trial's initiation. SAR443820 aims to address inflammation and cell death in neurodegenerative diseases, and is part of a broader RIPK1 inhibitor program. The collaboration also includes other treatments for diseases such as ALS and Alzheimer's.
Denali Therapeutics announced significant advancements in its clinical portfolio, showcasing progress in four late-stage programs for MPS II, ALS, and Parkinson's disease. A focus on Transport Vehicle (TV) technology highlights ongoing clinical studies, including the IND submission for an additional ETV program and new Oligonucleotide TV targets. CEO Ryan Watts emphasized the broadened therapeutic approach and the commitment to addressing neurodegenerative diseases. Upcoming milestones include interim data presentations and participant recruitment for several clinical trials throughout 2023.
Denali Therapeutics announced interim Phase 1b results for DNL343 in ALS patients, highlighting its ability to effectively penetrate the blood-brain barrier and inhibit key biomarkers of disease progression. After 28 days of once-daily oral dosing, DNL343 was well tolerated. The company is now designing a Phase 2/3 trial to enter the HEALEY ALS Platform Trial. This trial aims to evaluate effective treatments for ALS, a disease with limited options. Results of the study will be presented at an upcoming symposium, emphasizing Denali's commitment to advancing therapies for neurodegenerative diseases.
Denali Therapeutics (Nasdaq: DNLI) reported its Q3 2022 results, showing a net loss of $103.3 million, an increase from $84.6 million in Q3 2021. Collaboration revenue decreased to $3.6 million from $5.3 million, primarily due to a decline in Takeda collaboration revenue. R&D expenses rose to $87.8 million, driven by increased activity in clinical programs. Denali also completed a public offering, raising $296.2 million. The company remains focused on developing treatments for neurodegenerative diseases with seven therapeutic candidates.
Denali Therapeutics (NASDAQ: DNLI) announced interim results from Part A of a Phase 1/2 study for DNL593, showing dose-dependent increases in cerebrospinal fluid (CSF) progranulin levels in healthy volunteers, indicating effective brain delivery. The single doses were generally well tolerated, supporting progression to Part B, which will involve participants with frontotemporal dementia (FTD-GRN). Currently, there are no approved treatments for FTD, underscoring the potential significance of DNL593 as a progranulin replacement therapy.
Denali Therapeutics (NASDAQ: DNLI) announced the successful closing of its upsized public offering of 11,933,962 shares at $26.50 each, generating approximately $316 million before expenses. The offering included full exercise of the underwriters' option for additional shares. Major underwriters included Goldman Sachs, J.P. Morgan, and Jefferies. This offering is part of Denali's strategy to enhance its financial resources as it develops therapies targeting neurodegenerative diseases through innovative approaches.
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