Denali Therapeutics Inc. - DNLI STOCK NEWS

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.

Denali Therapeutics announced the appointment of Katie Peng as Chief Commercial Officer to enhance its commercial strategy for neurodegenerative diseases. Ms. Peng, formerly at Genentech with $14 billion revenue responsibility, brings extensive experience in launching successful treatments for neurological and rare diseases. Her leadership is expected to advance Denali's clinical pipeline, including therapies for Parkinson's disease and Hunter syndrome. CEO Ryan Watts emphasized the strategic importance of her role in developing Denali's commercial organization.

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.