Business
Denali Therapeutics Reports Full Year 2020 Financial Results and Business Highlights
SOUTH SAN FRANCISCO, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad
About this update from Denali Therapeutics Inc.
[{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today reported financial results for the full year ended December 31, 2020 and provided business highlights. \"We kicked off 2021 with more encouraging data from our ETV:IDS (DNL310) Phase 1/2 study in Hunter syndrome, further suggesting that we may be able to treat a wide array of diseases with CNS and bodily manifestations via intravenous infusion by leveraging our blood-brain barrier Transport Vehicle technology,” said Ryan Watts, Ph.D., Denali’s Chief Executive Officer. “In 2021 we plan to advance our lead LRRK2 inhibitor, DNL151 (BIIB122), with Biogen into late-stage development for Parkinson's disease and initiate our first patient study with our lead EIF2B activator, DNL343, in amyotrophic lateral sclerosis (ALS). In our RIPK1 inhibitor program partnered with Sanofi, we expect DNL758 (SAR443122), our lead peripherally-restricted molecule, to enter a Phase 2 study for cutaneous lupus erythematosus (CLE) and DNL788 (SAR443820), our lead brain-penetrant molecule, to complete a Phase 1 study in healthy volunteers. In parallel, we continue to advance additional therapeutic modalities, including PTV:PGRN (DNL593) for frontotemporal dementia and ATV:TREM2 (DNL919) for Alzheimer's disease, towards the clinic. We believe that we are well positioned to deliver on our ambitious goals this year on our path to becoming a fully integrated global organization to serve patients with neurodegenerative diseases.” Recent Business Highlights Reported positive 3-month data from Phase 1/2 study of DNL310 in patients with Hunter syndrome (MPS II): In February 2021, Denali reported additional interim data from Cohort A (n=5) in its Phase 1/2 study of DNL310 in patients with Hunter syndrome. The data showed that at dose levels resulting in robust and durable glycosaminoglycan (GAG) response in the central nervous system (CNS) and periphery, DNL310 was generally well tolerated with a safety profile consistent with standard of care enzyme replacement therapy (ERT). In addition, early effects on GAGs initially seen after four weeks of treatment with DNL310 (as announced in November 2020) w...