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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.
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Denali Therapeutics Inc. (DNLI) and Biogen Inc. have entered a significant collaboration with Biogen exercising its option to license Denali's Antibody Transport Vehicle (ATV):Amyloid beta program (ATV:Aβ) aimed at Alzheimer’s treatment.
The ATV technology is designed to enhance the delivery of therapeutic antibodies across the blood-brain barrier, potentially improving efficacy against amyloid beta plaque, a key feature of Alzheimer’s disease. Following this agreement, Biogen will manage all development and commercialization efforts related to the program, while Denali will receive an option exercise payment and may earn milestone payments and royalties based on future sales. This collaboration builds on the partnership initiated in 2020.
Denali Therapeutics announced promising data for DNL343, an investigational treatment for amyotrophic lateral sclerosis (ALS), indicating it is well-tolerated, effective in inhibiting stress response biomarkers, and supports once-daily dosing.
The company plans to initiate the Phase 2/3 HEALEY ALS Platform Trial for DNL343 in mid-2023, following a successful 28-day Phase 1b study involving 29 ALS patients. The upcoming results will be showcased at the American Academy of Neurology annual meeting on April 25, 2023.
DNL343 aims to enhance eIF2B activity, potentially preventing ALS progression by improving protein synthesis and neuronal health. The HEALEY trial is a collaborative effort to test multiple therapies simultaneously to expedite ALS treatment development.
Denali Therapeutics Inc. (Nasdaq: DNLI) reported its financial results for Q4 and full-year 2022, highlighting a strategic focus on late-stage clinical development for various neurodegenerative therapies. The company reported a net loss of $98.7 million for Q4, up from $75.3 million the previous year. Collaboration revenue decreased to $10.3 million in Q4, down from $12.5 million year-over-year, though total revenue for the year rose to $108.5 million. Operating expenses are expected to increase by 25-30% in 2023, driven by R&D investments, despite a cash position of $1.34 billion as of December 31, 2022.
Denali Therapeutics announced positive interim results from the Phase 1/2 study of DNL310 (ETV:IDS) for treating MPS II (Hunter syndrome). Data from 28 participants showed significant improvements in adaptive behavior, cognitive capabilities, and hearing after 49 weeks of treatment. DNL310 normalized cerebrospinal fluid levels of heparan sulfate and improved lysosomal function biomarkers. The safety profile is consistent with standard care, and data support continued enrollment in the upcoming Phase 2/3 COMPASS study. Denali also plans to submit an IND application for its second investigational therapy, DNL126, aimed at MPS IIIA.
Denali Therapeutics Inc. (Nasdaq: DNLI) announced key presentations at the 19th Annual WORLD Symposium from February 22-26, 2023, in Orlando, Florida. The focus will be on DNL310 (ETV:IDS) for treating MPS II (Hunter syndrome) and DNL126 (ETV:SGSH) for MPS IIIA (Sanfilippo syndrome type A). Presentations will cover interim clinical data from the Phase 2/3 COMPASS study and preclinical data for DNL126. DNL310 is being evaluated in a global study to address multiple symptoms of Hunter syndrome, and it has received Fast Track and Priority Medicines designations from regulatory authorities. Both therapies aim to provide critical treatment advancements for patients with neurodegenerative lysosomal storage diseases.