Denali Therapeutics Inc. - DNLI STOCK NEWS

Denali Therapeutics announced plans to offer $250 million in common stock through an underwritten public offering. The company will also provide underwriters a 30-day option to purchase an additional 15% of the shares. This offering is subject to market conditions and other factors. Goldman Sachs, J.P. Morgan, and Jefferies are the joint book-running managers for the offering. The shares will be offered under Registration Statement Form S-3, with terms to be finalized in a subsequent prospectus supplement.

Denali Therapeutics and Biogen have initiated the global Phase 3 LIGHTHOUSE study to assess the efficacy and safety of BIIB122 (DNL151), a small molecule inhibitor targeting LRRK2 mutations in Parkinson's disease. With around 400 participants, the trial will last up to 180 weeks and primarily measure the time to confirmed worsening of symptoms via the MDS-UPDRS scale. This landmark trial aims to test the genetic hypothesis of LRRK2's role in Parkinson's and could provide significant insights into treating this neurodegenerative disease.

Denali Therapeutics announced promising interim results from its Phase 1/2 trial of DNL310 for Hunter syndrome. The data shows sustained normalization of CSF heparan sulfate levels and improvements in biomarkers of lysosomal function over a year. Most participants reported stabilization or improvement in symptoms. With a safety profile comparable to standard care after up to 85 weeks of treatment, Denali is actively enrolling patients for the Phase 2/3 COMPASS study. The trial aims to further demonstrate DNL310's efficacy and its potential to treat cognitive and behavioral symptoms associated with Hunter syndrome.

Denali Therapeutics Inc. (NASDAQ: DNLI) reported its second quarter 2022 financial results, showing a net loss of $58.8 million, a slight improvement from a $60.7 million loss in Q2 2021. Collaboration revenue surged to $52.5 million, up from $22.9 million, mainly due to significant milestones from ongoing clinical developments. Denali's portfolio includes three BBB Transport Vehicle programs and seven overall in clinical trials. Their ongoing clinical studies in ALS and other neurodegenerative diseases are progressing, with upcoming data presentations expected in late 2022.

Denali Therapeutics (NASDAQ: DNLI) and Biogen have initiated the global Phase 2b LUMA study evaluating BIIB122 for early-stage Parkinson’s disease. The study aims to enroll about 640 participants aged 30 to 80 and assesses the drug's efficacy compared to a placebo. The primary endpoint focuses on changes in movement disorder scales. BIIB122 is a novel LRRK2 inhibitor, targeting a critical biological pathway in Parkinson’s disease, which affects millions worldwide. The collaboration marks a significant milestone in developing potential treatments for this condition.

Denali Therapeutics Inc. (Nasdaq: DNLI) reported its Q1 2022 financial results, with a net loss of $65.2 million, down from $70.0 million in Q1 2021. Collaboration revenue surged to $42.1 million, primarily due to partnerships with Takeda and Biogen. Denali is progressing with its drug candidates, including DNL593 for frontotemporal dementia and DNL310 for Hunter syndrome, with significant study advancements. However, the company faces challenges including a formal clinical hold from the FDA on DNL919, which may delay future studies.

Denali Therapeutics (NASDAQ: DNLI) announced a milestone as partner Sanofi begins dosing in a Phase 2 trial of SAR443820 (DNL788) for amyotrophic lateral sclerosis (ALS). Denali will receive a $40 million milestone payment for this initiation. SAR443820 is a CNS-penetrant RIPK1 inhibitor aimed at addressing ALS, a disease with critical unmet treatment needs. The study, part of a collaboration formed in 2018, evaluates safety and efficacy in about 260 participants. Additionally, SAR443820 has received FDA Fast Track designation, facilitating its development for ALS.

Denali Therapeutics (NASDAQ: DNLI) announced a leadership transition where Steve Krognes will step down as CFO to join the Board of Directors effective May 1, 2022. Alexander Schuth, the current COO, will take on the CFO role, becoming Denali's Chief Operating and Financial Officer. Krognes has significantly impacted Denali since 2015, contributing to its financial strength, including leading the successful IPO in 2017. This transition aims to maintain continuity and leverage Schuth’s extensive experience in business strategy and finance to strengthen Denali’s ongoing initiatives in neurodegenerative disease treatments.

Denali Therapeutics (NASDAQ: DNLI) has initiated dosing for its Phase 1/2 trial of DNL593, a therapy targeted at frontotemporal dementia (FTD) linked to granulin gene mutations. This study marks a significant milestone as Denali collaborates with Takeda to develop DNL593, which aims to enhance progranulin levels in the brain, potentially slowing FTD progression. The trial will evaluate safety and effectiveness in both healthy volunteers and FTD patients, with initial data expected in 2022. This follows Denali’s broader aim to address neurodegenerative diseases through innovative drug delivery mechanisms.