Denali Therapeut Stock Price, News & Analysis

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.

Denali Therapeutics (NASDAQ: DNLI) announced its participation in the 17th Annual WORLD Symposium™ from February 8-12, 2021. The company will present new clinical and preclinical data for ETV:IDS (DNL310), aimed at treating Hunter syndrome, a rare neurodegenerative disorder. Details include safety and biomarker data from an ongoing Phase 1/2 study. Denali will also host a webinar on February 12 at 8:00 a.m. ET for analysts to discuss these findings. For more information, visit their website.

Denali Therapeutics (NASDAQ: DNLI) has announced the appointment of Nancy Thornberry to its Board of Directors, effective January 8, 2021. Ms. Thornberry brings over 30 years of experience in biotech and pharmaceuticals, with a notable history in diabetes and endocrinology. Denali's CEO, Ryan Watts, expressed excitement about her joining, highlighting her extensive expertise in pharmaceutical development. Thornberry aims to leverage her insights to advance Denali's portfolio targeting neurodegenerative diseases, recognizing the critical medical challenges these conditions represent.

Denali Therapeutics (NASDAQ: DNLI) unveiled advancements in its clinical programs during a presentation at the J.P. Morgan Healthcare Conference. Key highlights include the late-breaker presentation of 12-week data from the Phase 1/2 study of DNL310 for Hunter syndrome on February 12. Denali is expanding its study with a third cohort and introducing five new enzyme replacement therapy programs. Furthermore, clinical development for the LRRK2 inhibitor DNL151 in Parkinson’s disease will begin by year-end 2021. The company aims for significant growth with its innovative therapeutic portfolio in 2021.

Denali Therapeutics Inc. (NASDAQ: DNLI) announced biomarker proof of concept for its DNL310 treatment in a Phase 1/2 study for Hunter syndrome. After four weeks of treatment, a 76% mean reduction in cerebrospinal fluid (CSF) GAG levels was observed, with normal levels achieved in four out of five patients. The independent data monitoring committee recommended proceeding with the study without modifications, allowing further enrollment of younger patients. DNL310 employs Denali's proprietary Transport Vehicle technology to cross the blood-brain barrier, offering new therapeutic potential for neurodegenerative disorders.