Denali Therapeut Stock Price, News & Analysis

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.

Denali Therapeutics Inc. (NASDAQ: DNLI) reported a positive financial turnaround for the full year 2020, posting a net income of $71.1 million compared to a net loss of $197.6 million in 2019. Collaboration revenue surged to $335.7 million, driven by a significant agreement with Biogen. Key developments include promising data from their DNL310 study in Hunter syndrome and advancements in their late-stage LRRK2 inhibitor, DNL151, for Parkinson's disease. Denali's cash reserves stood at $1.5 billion, indicating a strong financial position for growth in 2021.

Denali Therapeutics (NASDAQ: DNLI) announced positive interim results from its Phase 1/2 study of DNL310, an enzyme replacement therapy for Hunter syndrome. After three months of treatment, a significant reduction in cerebrospinal fluid (CSF) heparan sulfate levels was observed, supporting improved lysosomal function. The therapy was well tolerated, with mild infusion-related reactions reported. Denali plans to present these findings at the WORLD Symposium and will host an analyst webinar today at 8:00 a.m. ET to discuss the results.