Welcome to our dedicated page for Denali Therapeut news (Ticker: DNLI), a resource for investors and traders seeking the latest updates and insights on Denali Therapeut stock.
Denali Therapeutics Inc. develops medicines for neurodegenerative diseases, lysosomal storage disorders and other serious diseases using its proprietary TransportVehicle™ platform, which is designed to deliver biotherapeutics across the blood-brain barrier. Company news centers on AVLAYAH™ (tividenofusp alfa-eknm), an FDA-approved enzyme replacement therapy for Hunter syndrome (MPS II), and on pipeline programs that use enzyme, protein, oligonucleotide and antibody transport technologies.
Recurring updates cover clinical and preclinical data for programs in Sanfilippo syndrome type A, Pompe disease, Alzheimer’s disease, frontotemporal dementia and Parkinson’s disease, as well as regulatory decisions, conference presentations, collaboration changes, commercial launch activity and quarterly financial results.
Denali Therapeutics (NASDAQ: DNLI) has announced the commencement of dosing for DNL758 (SAR443122) in a Phase 1b trial aimed at assessing its safety and efficacy in patients with severe COVID-19. Partnered with Sanofi, DNL758 is a small molecule inhibitor of RIPK1, designed to mitigate the immune response to SARS-CoV-2. The trial seeks to reduce tissue damage from inflammation, potentially improving recovery rates. Sanofi oversees the trial's development and financing, while Denali will receive milestone payments and royalties from product sales.
Denali Therapeutics (NASDAQ: DNLI) and Sanofi have decided to pause clinical activities for DNL747 due to the totality of data suggesting a superior profile for the backup compound DNL788. The companies plan to accelerate DNL788’s development for neurological indications, aiming to initiate clinical testing by early 2021. While DNL747 demonstrated safety in Phase 1b studies for ALS and Alzheimer’s, it faced limitations on dose escalation due to toxicity findings. Additionally, Sanofi is planning further studies for its compound DNL758 after a successful Phase 1 trial.
Denali Therapeutics (NASDAQ: DNLI) has announced advancements in its proprietary Transport Vehicle (TV) technology, enabling effective delivery of therapeutic proteins across the blood-brain barrier (BBB). Two significant papers published in Science Translational Medicine detail the TV platform's ability to improve brain exposure of therapeutic proteins, specifically in relation to DNL310, aimed at treating Hunter syndrome. Clinical data for DNL310 is expected by late 2020, and the EngageHunter.com website offers information on ongoing studies and patient engagement.
Denali Therapeutics Inc. (NASDAQ: DNLI) reported a net loss of $56.8 million for Q1 2020, compared to $39.0 million in the same quarter last year. Collaboration revenue decreased to $3.6 million, attributed mainly to a $2.9 million decline from Sanofi, offset by a $2.3 million increase from Takeda. Total R&D expenses rose to $51.0 million, influenced by external expenses for key programs and higher personnel costs. General and administrative expenses also increased to $12.6 million. As of March 31, 2020, the company held $596.9 million in cash and marketable securities.