Denali Therapeut Stock Price, News & Analysis

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.

Denali Therapeutics (NASDAQ: DNLI) reported its 2021 financial results, revealing a net loss of $290.6 million, a notable decline from a net income of $71.1 million in 2020. The company plans to advance several clinical trials in 2022, focusing on Parkinson's disease and ALS. Noteworthy is the anticipated 25-30% increase in operating expenses for 2022, offset by expected cash milestones from partnerships. As of December 31, 2021, the company held $1.3 billion in cash and marketable securities.

Denali Therapeutics announced promising long-term results from their Phase 1/2 trial of DNL310 for Hunter syndrome. Data reveals sustained normalization of cerebrospinal fluid (CSF) heparan sulfate and improved lysosomal function markers in 20 patients over up to one year. DNL310's safety profile aligns with standard enzyme replacement therapies, exhibiting primarily mild infusion-related reactions. The findings support a Phase 2/3 trial initiation in 2022 to assess DNL310's efficacy and safety in a broader patient cohort.

Denali Therapeutics Inc. (NASDAQ: DNLI) announced the appointment of Erik Harris to its Board of Directors. Mr. Harris brings 20 years of experience in biotech leadership and commercial operations across various therapeutic areas, particularly in neurological and rare diseases. CEO Ryan Watts highlighted Harris's valuable insights as Denali transitions into late-stage development of its diverse portfolio targeting neurodegenerative diseases. Harris currently serves as Chief Commercial Officer at Ultragenyx Pharmaceutical and has a proven track record of successful product launches.

Denali Therapeutics (NASDAQ: DNLI) announced that it will present data from its DNL310 clinical development program at the 18th Annual WORLD Symposium™ on February 10, 2022. DNL310 is a brain-penetrant enzyme replacement therapy aimed at treating MPS II (Hunter syndrome). Key presentations include interim results from a Phase 1/2 trial and plans for a Phase 2/3 trial. DNL310 aims to address both CNS and peripheral symptoms, overcoming limitations of existing therapies that do not effectively cross the blood-brain barrier.

Denali Therapeutics (NASDAQ: DNLI) announced that the FDA has placed a clinical hold on its DNL919 (ATV:TREM2) Investigational New Drug (IND) application as of January 12, 2022. The FDA will send an official clinical hold letter within approximately 30 days. Denali is committed to providing further updates following discussions with the FDA regarding this hold. The company focuses on developing therapies for neurodegenerative diseases by enabling drug delivery across the blood-brain barrier.

Denali Therapeutics (NASDAQ: DNLI) announced significant advancements in its clinical pipeline aimed at treating neurodegenerative diseases. Expected milestones in 2022 include the initiation of late-stage trials for DNL310 in MPS II and DNL151 for Parkinson's disease, along with Phase 1b data for DNL343 in ALS. The company partners with Sanofi for RIPK1 inhibitors and has entered into co-development agreements with Takeda for DNL919 and DNL593. New data affirm the efficacy of Denali’s Transport Vehicle platform, emphasizing its potential for enhancing drug delivery to the brain.