Denali Therapeut Stock Price, News & Analysis

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.

Denali Therapeutics announced interim Phase 1b results for DNL343 in ALS patients, highlighting its ability to effectively penetrate the blood-brain barrier and inhibit key biomarkers of disease progression. After 28 days of once-daily oral dosing, DNL343 was well tolerated. The company is now designing a Phase 2/3 trial to enter the HEALEY ALS Platform Trial. This trial aims to evaluate effective treatments for ALS, a disease with limited options. Results of the study will be presented at an upcoming symposium, emphasizing Denali's commitment to advancing therapies for neurodegenerative diseases.

Denali Therapeutics (Nasdaq: DNLI) reported its Q3 2022 results, showing a net loss of $103.3 million, an increase from $84.6 million in Q3 2021. Collaboration revenue decreased to $3.6 million from $5.3 million, primarily due to a decline in Takeda collaboration revenue. R&D expenses rose to $87.8 million, driven by increased activity in clinical programs. Denali also completed a public offering, raising $296.2 million. The company remains focused on developing treatments for neurodegenerative diseases with seven therapeutic candidates.

Denali Therapeutics (NASDAQ: DNLI) announced interim results from Part A of a Phase 1/2 study for DNL593, showing dose-dependent increases in cerebrospinal fluid (CSF) progranulin levels in healthy volunteers, indicating effective brain delivery. The single doses were generally well tolerated, supporting progression to Part B, which will involve participants with frontotemporal dementia (FTD-GRN). Currently, there are no approved treatments for FTD, underscoring the potential significance of DNL593 as a progranulin replacement therapy.

Denali Therapeutics (NASDAQ: DNLI) announced the successful closing of its upsized public offering of 11,933,962 shares at $26.50 each, generating approximately $316 million before expenses. The offering included full exercise of the underwriters' option for additional shares. Major underwriters included Goldman Sachs, J.P. Morgan, and Jefferies. This offering is part of Denali's strategy to enhance its financial resources as it develops therapies targeting neurodegenerative diseases through innovative approaches.

Denali Therapeutics (NASDAQ: DNLI) has announced the pricing of a public offering, selling 10,377,359 shares of common stock at $26.50 per share. The offering is expected to generate approximately $275 million in gross proceeds, excluding underwriter options for an additional 1,556,603 shares. The offering is anticipated to close on or about October 24, 2022. Goldman Sachs, J.P. Morgan, and Jefferies are leading the underwriting. Proceeds will support Denali's development of products targeting neurodegenerative diseases.

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.