Denali Therapeut Stock Price, News & Analysis

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.

Denali Therapeutics (DNLI) announced a significant milestone as its partner, Sanofi, has begun dosing in a Phase 2 clinical trial of SAR443820 (DNL788) for multiple sclerosis. This trial follows the successful Phase 1 trial, which showed robust target engagement and CNS penetration. Denali will receive a $25 million milestone payment from Sanofi for the trial's initiation. SAR443820 aims to address inflammation and cell death in neurodegenerative diseases, and is part of a broader RIPK1 inhibitor program. The collaboration also includes other treatments for diseases such as ALS and Alzheimer's.

Denali Therapeutics announced significant advancements in its clinical portfolio, showcasing progress in four late-stage programs for MPS II, ALS, and Parkinson's disease. A focus on Transport Vehicle (TV) technology highlights ongoing clinical studies, including the IND submission for an additional ETV program and new Oligonucleotide TV targets. CEO Ryan Watts emphasized the broadened therapeutic approach and the commitment to addressing neurodegenerative diseases. Upcoming milestones include interim data presentations and participant recruitment for several clinical trials throughout 2023.