Denali Therapeutics Inc. - DNLI STOCK NEWS

Denali Therapeutics announced promising long-term results from their Phase 1/2 trial of DNL310 for Hunter syndrome. Data reveals sustained normalization of cerebrospinal fluid (CSF) heparan sulfate and improved lysosomal function markers in 20 patients over up to one year. DNL310's safety profile aligns with standard enzyme replacement therapies, exhibiting primarily mild infusion-related reactions. The findings support a Phase 2/3 trial initiation in 2022 to assess DNL310's efficacy and safety in a broader patient cohort.

Denali Therapeutics Inc. (NASDAQ: DNLI) announced the appointment of Erik Harris to its Board of Directors. Mr. Harris brings 20 years of experience in biotech leadership and commercial operations across various therapeutic areas, particularly in neurological and rare diseases. CEO Ryan Watts highlighted Harris's valuable insights as Denali transitions into late-stage development of its diverse portfolio targeting neurodegenerative diseases. Harris currently serves as Chief Commercial Officer at Ultragenyx Pharmaceutical and has a proven track record of successful product launches.

Denali Therapeutics (NASDAQ: DNLI) announced that it will present data from its DNL310 clinical development program at the 18th Annual WORLD Symposium™ on February 10, 2022. DNL310 is a brain-penetrant enzyme replacement therapy aimed at treating MPS II (Hunter syndrome). Key presentations include interim results from a Phase 1/2 trial and plans for a Phase 2/3 trial. DNL310 aims to address both CNS and peripheral symptoms, overcoming limitations of existing therapies that do not effectively cross the blood-brain barrier.

Denali Therapeutics (NASDAQ: DNLI) announced that the FDA has placed a clinical hold on its DNL919 (ATV:TREM2) Investigational New Drug (IND) application as of January 12, 2022. The FDA will send an official clinical hold letter within approximately 30 days. Denali is committed to providing further updates following discussions with the FDA regarding this hold. The company focuses on developing therapies for neurodegenerative diseases by enabling drug delivery across the blood-brain barrier.

Denali Therapeutics (NASDAQ: DNLI) announced significant advancements in its clinical pipeline aimed at treating neurodegenerative diseases. Expected milestones in 2022 include the initiation of late-stage trials for DNL310 in MPS II and DNL151 for Parkinson's disease, along with Phase 1b data for DNL343 in ALS. The company partners with Sanofi for RIPK1 inhibitors and has entered into co-development agreements with Takeda for DNL919 and DNL593. New data affirm the efficacy of Denali’s Transport Vehicle platform, emphasizing its potential for enhancing drug delivery to the brain.

Denali Therapeutics (NASDAQ: DNLI) announced a milestone in its collaboration with Takeda Pharmaceutical, who has exercised an option to co-develop DNL593, a progranulin replacement therapy aimed at treating frontotemporal dementia-granulin (FTD-GRN). This marks DNL593 as Denali's sixth therapeutic candidate in clinical development, underlining the potential of Denali's Transport Vehicle platform technology. Takeda will contribute to the development and commercialization of DNL593, sharing costs and profits equally. Clinical trial applications are expected soon as preclinical studies show promising results for DNL593.

Denali Therapeutics Inc. (NASDAQ: DNLI) reported Q3 2021 financial results with a net loss of $84.6 million versus $58.2 million a year prior. Collaboration revenue decreased to $5.3 million from $9.4 million, primarily due to reduced income from Takeda. R&D expenses surged to $71.6 million, driven by personnel costs and ongoing clinical programs, while G&A expenses rose to $19.3 million. The company continues advancing its therapeutic pipeline, including a Phase 1b study of DNL343 in ALS. Denali holds approximately $1.36 billion in cash and securities as of September 30, 2021.

Denali Therapeutics (NASDAQ: DNLI) announced promising clinical results for DNL343 and SAR443820, investigational treatments for amyotrophic lateral sclerosis (ALS). A Phase 1 study of DNL343, which activates eIF2B, showed it was well-tolerated and achieved biomarker goals. The FDA granted Fast Track designation for SAR443820, a RIPK1 inhibitor, paving the way for a Phase 2 trial in early 2022. These advancements are critical as ALS lacks effective treatments, and both compounds target pathways involved in the disease's progression.

Denali Therapeutics (NASDAQ: DNLI) will present results from a Phase 1 healthy volunteer study of its EIF2B activator DNL343 at the upcoming 2021 Annual NEALS Meeting on October 6-7. DNL343 is currently in a Phase 1b study for ALS. Sanofi, Denali's partner, will also share plans for a Phase 2 study of RIPK1 inhibitor SAR443820. The webinar for analysts and investors will take place on October 6 at 4:30 p.m. ET, covering developments in ALS and frontotemporal dementia.