Denali Therapeutics

Denali Therapeutics, Inc. is a biopharmaceutical company, which engages in the development and commercialization of a portfolio of product candidates for neurodegenerative diseases. Its product pipeline includes LRRK2, RIPK1, TREM2, and Tau. The company was founded by Ryan J. Watts, Marc Tessier-Lavigne, and Alexander Schuth on October 14, 2013 and is headquartered in San Francisco, CA.

Earnings data Q1 2023

Earnings data Q2 2023

Denali (DNLI) reports better-than-expected results for the fourth quarter and full-year 2022, as it beats both earnings and revenue estimates.

Denali (DNLI) Q4 Earnings Beat Estimates, Pipeline in Focus

Denali Therapeutics Inc. (DNLI) delivered earnings and revenue surprises of 3.85% and 28.09%, respectively, for the quarter ended December 2022. Do the numbers hold clues to what lies ahead for the stock?

Denali Therapeutics Inc. (DNLI) Reports Q4 Loss, Tops Revenue Estimates

SOUTH SAN FRANCISCO, Calif., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases, today reported financial results for the fourth quarter and year ended December 31, 2022, and provided business highlights.

Denali Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Business Highlights

SOUTH SAN FRANCISCO, Calif., Feb. 22, 2023 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier for the treatment of neurodegenerative diseases and lysosomal storage diseases, today announced new interim results from the ongoing open-label, single-arm Phase 1/2 study of DNL310 (ETV:IDS) in children with MPS II (Hunter syndrome), including data from additional participants and up to 104 weeks of treatment. DNL310 is an investigational brain-penetrant enzyme replacement therapy designed to address the behavioral, cognitive, and physical manifestations of MPS II. The interim Phase 1/2 data are being presented at the 19th Annual WORLDSymposium™ in Orlando, Florida, February 22-26, 2023.

Denali Therapeutics Announces New Interim Data from DNL310 Phase 1/2 Study for MPS II and DNL126 Preclinical Data for MPS IIIA at WORLDSymposium™

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Denali Therapeutics Inc. (DNLI) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Earnings Preview: Denali Therapeutics Inc. (DNLI) Q4 Earnings Expected to Decline

SOUTH SAN FRANCISCO, Calif., Feb. 15, 2023 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier for the treatment of neurodegenerative diseases and lysosomal storage diseases, today announced upcoming presentations from Enzyme Transport Vehicle (ETV) development programs, DNL310 (ETV:IDS) and DNL126 (ETV:SGSH), to be given at the 19th Annual WORLDSymposium™, which will be held February 22-26, 2023, in Orlando, Florida.

Denali Therapeutics Announces Presentations on Enzyme Transport Vehicle (ETV) Development Programs for MPS Diseases at the Upcoming WORLDSymposium™

Denali Therapeutics Inc. (DNLI) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions could translate into further price increase in the near term.

Denali Therapeutics Inc. (DNLI) Surges 5.8%: Is This an Indication of Further Gains?

SOUTH SAN FRANCISCO, Calif., Jan. 25, 2023 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier for the treatment of neurodegenerative diseases and lysosomal storage diseases, today announced that its partner Sanofi has commenced dosing in a Phase 2 study of SAR443820 (DNL788) in individuals with multiple sclerosis. SAR443820 is a central nervous system (CNS)-penetrant investigational small molecule inhibitor of RIPK1.

Denali Therapeutics Announces Achievement of RIPK1 Milestone for Phase 2 Clinical Trial Initiation in Multiple Sclerosis by Sanofi

Denali Therapeutics Inc. has major partnerships and an active set of programs. They are flush with cash.

Denali: Need Patient Data To Justify That High Valuation

SOUTH SAN FRANCISCO, Calif., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases and lysosomal storage diseases, today announced program progress and expected milestones for 2023, which Chief Executive Officer, Ryan Watts, Ph.D., will highlight during a corporate presentation at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10th, at 10:30 a.m. Pacific Time.

Denali Therapeutics Announces Key Anticipated 2023 Milestones for Its Therapeutic Portfolio for Neurodegeneration and Lysosomal Storage Diseases

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SOUTH SAN FRANCISCO, Calif., Dec. 05, 2022 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases and lysosomal storage disorders, today announced interim results from a Phase 1b study of its eIF2B agonist, DNL343, in participants with amyotrophic lateral sclerosis (ALS). Once-daily oral dosing with DNL343 for 28 days was generally well tolerated and demonstrated extensive BBB penetration as well as robust inhibition of biomarkers associated with the integrated stress response (ISR) in blood samples from study participants. By inhibiting the ISR pathway, DNL343 is intended to prevent or slow disease progression associated with stress granule formation and TDP-43 aggregation, a hallmark pathology present in nearly all individuals with ALS. The Phase 1b results will be presented at the 33rd International Symposium on ALS/MND, which is being held virtually December 6-9, 2022. A copy of the poster presentation is available on Denali's website on the Investor & Media Relations section under the Events page. Denali also announced initiation of the design phase of a Phase 2/3 study for entry into the HEALEY ALS Platform Trial led by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital (MGH) in collaboration with the Northeast ALS Consortium.

Denali Therapeutics Announces DNL343 Interim Phase 1b Data in ALS and Entry into the HEALEY ALS Platform Trial

Denali (DNLI) posts a wider Q3 loss. Collaboration revenues decline year over year.

Denali (DNLI) Lags Q3 Earnings Estimates, Pipeline in Focus

Denali Therapeutics Inc. (DNLI) delivered earnings and revenue surprises of -1.20% and 64.61%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?

Denali Therapeutics Inc. (DNLI) Reports Q3 Loss, Lags Revenue Estimates

SOUTH SAN FRANCISCO, Calif., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today reported financial results for the third quarter ended September 30, 2022, and provided business highlights.

Denali Therapeutics Reports Third Quarter 2022 Financial Results and Business Highlights

The biopharmaceutical stock was actually up as much as 12.4% before falling a bit at the close.

Why Denali Therapeutics' Stock Rose 6.6% on Wednesday

SOUTH SAN FRANCISCO, Calif., Nov. 01, 2022 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier for neurodegenerative diseases and lysosomal storage disorders, today announced interim results from Part A of a Phase 1/2 study evaluating TAK-594/DNL593 (PTV:PGRN) in healthy subjects. Progranulin (PGRN) levels measured in cerebrospinal fluid (CSF) increased in a dose-dependent manner compared to baseline and placebo, consistent with brain delivery of DNL593 and exceeding levels believed to be necessary to rescue deficits associated with progranulin deficiency, based on preclinical models.1 Single doses of DNL593 were generally well tolerated, based on blinded safety analysis. These data support dosing in participants with frontotemporal dementia and a mutation in the granulin gene (FTD-GRN) in Part B of the study. DNL593 is an investigational, brain-penetrant progranulin replacement therapy being co-developed by Denali and Takeda. These data were presented at the FTD Prevention Initiative meeting in Paris, France. A copy of the presentation is available on Denali's website on the Investor & Media Relations section under the Events page.

Denali Therapeutics Announces Phase 1/2 Study Single Dose Healthy Volunteer Data with TAK-594/DNL593 (PTV:PGRN) and Progression to Enrolling Participants with FTD-GRN

Denali Therapeutics initiated a phase 3 study, using BIIB122 for the treatment of Parkinson's Disease patients with the pathogenic mutation of LRRK2, in October of 2022. The company initiated a phase 2b study, using BIIB122 for the treatment of early-stage Parkinson's Disease patients, in May of 2022.

Denali Therapeutics: Two Shots On Goal For Parkinson's Disease Treatment

SOUTH SAN FRANCISCO, Calif., Oct. 24, 2022 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI) today announced the closing of its upsized underwritten public offering of 11,933,962 shares of its common stock at a price to the public of $26.50 per share, which includes the exercise in full by the underwriters of their option to purchase additional shares. The total gross proceeds from the offering, before deducting underwriters' discounts and commissions and estimated offering expenses, are approximately $316 million.

Denali Therapeutics Announces Closing of a $316 Million Public Offering, Including Full Exercise of Underwriters' Option to Purchase Additional Shares

SOUTH SAN FRANCISCO, Calif., Oct. 19, 2022 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI) today announced the pricing of its underwritten public offering of 10,377,359 shares of its common stock at a price to the public of $26.50 per share. All of the shares are to be sold by Denali Therapeutics. In addition, Denali Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,556,603 shares of its common stock. Before deducting the underwriting discounts and commissions and estimated offering expenses, Denali Therapeutics expects to receive total gross proceeds of approximately $275 million, assuming no exercise of the underwriters' option to purchase additional shares. The offering is expected to close on or about October 24, 2022, subject to satisfaction of customary closing conditions.

Denali Therapeutics Announces Pricing of $275 Million Public Offering of Common Stock

SOUTH SAN FRANCISCO, Calif., Oct. 18, 2022 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI) today announced that it intends to offer and sell $250 million of shares of its common stock in an underwritten public offering. In addition, Denali Therapeutics intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Denali Therapeutics Announces Proposed Offering of Common Stock

CAMBRIDGE, Mass. and SOUTH SAN FRANCISCO, Calif., Oct. 03, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that dosing has commenced in the global Phase 3 LIGHTHOUSE study to evaluate the efficacy and safety profile of BIIB122 (DNL151), as compared to placebo in approximately 400 participants with Parkinson's disease and a confirmed pathogenic mutation in the leucine-rich repeat kinase 2 (LRRK2) gene.

Biogen and Denali Therapeutics Announce Initiation of the Phase 3 LIGHTHOUSE Study in Parkinson's Disease Associated with LRRK2 Pathogenic Mutations

Denali Therapeutics Inc. (DNLI) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions may not translate into further price increase in the near term.

Denali Therapeutics Inc. (DNLI) Moves 17.7% Higher: Will This Strength Last?

Denali Therapeutics Inc. (DNLI) reported earnings 30 days ago. What's next for the stock?

News for Denali Therapeutics Stock (DNLI)