Denali Therapeut Stock Price, News & Analysis

Denali Therapeutics (NASDAQ: DNLI) has initiated dosing in a Phase 1b study of DNL343, a potential first-in-class treatment for amyotrophic lateral sclerosis (ALS). This study aims to evaluate the safety and efficacy of DNL343, which activates EIF2B, a protein complex crucial for neuronal health. ALS currently affects over 20,000 people in the U.S. annually. Denali plans to present preliminary data at the upcoming NEALS Meeting on October 6, 2021, highlighting the treatment’s significance for addressing critical unmet medical needs in ALS.

Denali Therapeutics (NASDAQ: DNLI) published preclinical findings demonstrating the efficacy of its Protein Transport Vehicle (PTV) in enhancing brain uptake of progranulin. This approach shows promise for treating frontotemporal dementia (FTD), particularly FTD-GRN, resulting from progranulin deficiency. The study, published in Cell, indicates that PTV:PGRN improves lysosomal function and addresses neurodegeneration in mouse models. Denali aims to initiate clinical testing for lead candidate DNL593, highlighting the potential therapeutic significance of its PTV technology.

Denali Therapeutics reported Q2 2021 financial results, showcasing a net loss of $60.7 million, slightly up from $58.8 million in Q2 2020. Collaboration revenue surged to $22.9 million, up from $5.8 million, primarily due to a $15 million milestone from Sanofi's Phase 2 study of DNL758. Significant progress was highlighted in the development of DNL310 for Hunter syndrome, demonstrating promising interim data in patient cohorts. Denali is set to initiate further clinical studies in ALS and Parkinson's disease by year-end 2021, with cash reserves approximating $1.4 billion.

Denali Therapeutics (NASDAQ: DNLI) reported positive interim results from its Phase 1/2 study of ETV:IDS (DNL310), a treatment for Hunter syndrome (MPS II). Findings showed a rapid reduction of heparan sulfate levels in cerebrospinal fluid (CSF) and significant clinical improvements in symptoms, cognitive and physical abilities. Safety data indicated a profile consistent with standard enzyme replacement therapy, with infusion-related reactions being the most common adverse events. Denali plans to initiate a pivotal Phase 2/3 study in the first half of 2022, indicating strong forward momentum for DNL310.

Denali Therapeutics (NASDAQ: DNLI) announced its participation in the MPS 2021 symposium, showcasing DNL310, an innovative brain-penetrant enzyme replacement therapy for Hunter syndrome. The company will present interim 24-week results from a Phase 1/2 study on July 25, 2021, followed by a webinar for analysts and investors. DNL310 aims to address the limitations of current treatments that don't effectively cross the blood-brain barrier. Denali's research efforts are significant for patients and families affected by this rare disease.

Denali Therapeutics (NASDAQ: DNLI) announced that its partner Sanofi has begun dosing in a Phase 2 trial of DNL758 for cutaneous lupus erythematosus (CLE). This small molecule inhibitor targets RIPK1, a protein involved in inflammation regulation. Denali will receive a $15 million milestone payment for this study, while Sanofi handles all development costs. Denali's collaboration with Sanofi, initiated in October 2018, aims to develop various RIPK1 inhibitors for neurodegenerative diseases. The trial results could significantly impact both companies' future prospects.

Denali Therapeutics Inc. (NASDAQ: DNLI) reported its Q1 2021 financial results, showing a net loss of $70 million, up from $56.8 million in Q1 2020.

Collaboration revenue increased to $7.9 million, driven by a rise in partnered program costs. R&D expenses rose to $60.2 million, influenced by higher personnel costs and pipeline investments. However, G&A expenses also increased to $18.9 million. Denali's cash position remains robust at $1.45 billion as of March 31, 2021. Key milestones were achieved for DNL310 in Hunter syndrome and DNL151 for Parkinson's, with several ongoing clinical studies.

Denali Therapeutics announced positive Phase 1 and 1b results for its LRRK2 inhibitor, BIIB122/DNL151, aimed at treating Parkinson's disease. The study involved 184 healthy volunteers and 36 Parkinson's patients, showing significant reductions in biomarkers indicating target engagement and lysosomal function. The drug demonstrated a favorable safety profile with no serious adverse events. Denali and Biogen plan to move into late-stage development by year-end 2021, marking a significant step for BIIB122/DNL151 as a potential oral therapy for Parkinson's.

Denali Therapeutics (NASDAQ: DNLI) announced that the FDA has granted Fast Track designation to its investigational therapy ETV:IDS (DNL310) for Hunter syndrome (MPS II), a severe neurodegenerative condition. DNL310 aims to effectively address both central nervous system and peripheral symptoms by using Denali's unique Transport Vehicle technology to cross the blood-brain barrier. This designation allows for expedited development and review processes, including rolling review and potential priority review of marketing applications, enhancing collaboration with the FDA.