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.

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Denali Therapeutics Inc. (DNLI) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock suggests that there could be more strength down the road.

Denali Therapeutics Inc. (DNLI) Moves 7.5% Higher: Will This Strength Last?

SOUTH SAN FRANCISCO, Calif., March 15, 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 announced that Steve Krognes will transition from his role as Chief Financial Officer (CFO) and join the company's Board of Directors on May 1, 2022. Denali's Chief Operating Officer Alexander Schuth, M.D., will add the Chief Financial Officer role to his current responsibilities, becoming Denali's Chief Operating and Financial Officer.

Denali Therapeutics Appoints Alexander Schuth as Chief Operating and Financial Officer as Steve Krognes Transitions to Denali Board of Directors

Denali (DNLI) starts an early-stage study of DNL593 for treating frontotemporal dementia (FTD) due to mutations in the granulin gene (GRN) in collaboration with Takeda.

Denali (DNLI) Begins Frontotemporal Dementia-Granulin Study

SOUTH SAN FRANCISCO, Calif., March 09, 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 announced that dosing has begun in a Phase 1/2 clinical trial of DNL593 (PTV:PGRN) for the potential treatment of frontotemporal dementia (FTD) caused by mutations in the granulin gene (GRN). Pending initial clinical data from the Phase 1 healthy volunteer portion of the clinical trial, Denali expects to begin dosing individuals with FTD-GRN in the second half of 2022. Denali and Takeda have a strategic collaboration to co-develop and co-commercialize DNL593.

Denali Therapeutics Announces Initiation of Phase 1/2 Clinical Trial of DNL593 (PTV:PGRN) for Frontotemporal Dementia-Granulin (FTD-GRN)

Denali (DNLI) announces wider-than-expected loss per share for fourth-quarter 2021. Revenues also miss estimates.

Denali (DNLI) Q4 Loss Wider Than Expected, Revenues Lag

Denali Therapeutics Inc. (DNLI) delivered earnings and revenue surprises of -51.22% and 67.21%, respectively, for the quarter ended December 2021. Do the numbers hold clues to what lies ahead for the stock?

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

SOUTH SAN FRANCISCO, Calif., Feb. 28, 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 fourth quarter and year ended December 31, 2021, and provided business highlights.

Denali Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Business Highlights

As previously announced, Denali Therapeutics Inc (NASDAQ: DNLI) was informed via e-mail communication from the FDA that DNL919 (ATV:TREM2) Investigational New Drug (IND) application was placed on clinical hold.  Denali has now received a formal clinical hold letter and is moving forward to address the FDA's observations related to the preclinical toxicology assessment.

Denali Receives Formal Letter Regarding FDA Hold On Alzheimer's Potential Program

SOUTH SAN FRANCISCO, Calif., Feb. 10, 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 announced that new longer-term data from an ongoing Phase 1/2 clinical trial of DNL310 (ETV:IDS) are being presented today at WORLDSymposium™. DNL310 is an investigational brain-penetrant enzyme replacement therapy intended to treat both central nervous system (CNS) and peripheral manifestations of MPS II (Hunter syndrome).

Denali Therapeutics Announces Continued Progress in DNL310 (ETV:IDS) Program for MPS II (Hunter Syndrome) Supporting Planned Initiation of Phase 2/3 Clinical Trial

SOUTH SAN FRANCISCO, Calif., Feb. 07, 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 announced that Erik Harris has joined the Board of Directors. Mr. Harris' extensive biotech leadership and pharmaceutical experience includes 20 years in all aspects of commercial operations and achieving successful product launches in multiple therapeutic areas, including neurological and rare diseases.

Denali Therapeutics Announces Appointment of Erik Harris to Board of Directors

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New York, New York--(Newsfile Corp. - February 2, 2022) - Pomerantz LLP is investigating claims on behalf of investors of Denali Therapeutics Inc. ("Denali" or the "Company") (NASDAQ: DNLI). Such investors are advised to contact Robert S. Willoughby at newaction@pomlaw.com or 888-476-6529, ext. 7980.The investigation concerns whether Denali and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining...

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Denali Therapeutics Inc. - DNLI

SOUTH SAN FRANCISCO, Calif., Feb. 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 (BBB) for neurodegenerative diseases, today announced upcoming presentations from the DNL310 (ETV:IDS) clinical development program to be given at the 18th Annual WORLDSymposium™, which will be held February 7-11, 2022, in San Diego, California, and virtually. DNL310 is an investigational brain-penetrant enzyme replacement therapy intended to treat both central nervous system (CNS) and peripheral manifestations of MPS II (Hunter syndrome).

Denali Therapeutics Announces Presentations on DNL310 (ETV:IDS) Development Program in MPS II (Hunter Syndrome) at the Upcoming WORLDSymposium™

The FDA placed a hold on the company's planned clinical trial of an experimental Alzheimer's disease drug.

Why Denali Therapeutics Stock Is Sinking This Week

The FDA has issued a clinical hold on Denali Therapeutics Inc's (NASDAQ: DNLI) Investigational New Drug (IND) application for DNL919 (ATV:TREM2). TREM2 is a protein expressed in microglia, the brain's resident immune cells.

FDA Places Clinical Hold On Denali's Alzheimer's Potential Program

SOUTH SAN FRANCISCO, Calif., Jan. 13, 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 announced that after the close of business (Eastern Time) on Wednesday, January 12, 2022, the company was informed via e-mail communication from the U.S. Food and Drug Administration (FDA) that the DNL919 (ATV:TREM2) Investigational New Drug (IND) application has been placed on clinical hold. The FDA indicated they will provide an official clinical hold letter to Denali in approximately 30 days. Denali plans to provide additional updates pending discussion with the FDA.

Denali Therapeutics Announces FDA Clinical Hold on DNL919 Investigational New Drug (IND) Application

SOUTH SAN FRANCISCO, Calif., Jan. 10, 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 announced program progress and expected milestones for 2022, which Chief Executive Officer, Ryan Watts, Ph.D., will highlight during a corporate presentation at the 40th Annual J.P. Morgan Healthcare Conference on Tuesday, January 11, at 11:15 a.m. Eastern Time.

Denali Therapeutics Announces Progression and Expansion of Broad Therapeutic Portfolio for Neurodegeneration and Expected Key Milestones in 2022

— Companies to advance clinical development of DNL593 as a brain-penetrant progranulin replacement therapy for frontotemporal dementia-granulin (FTD-GRN) —

Denali Therapeutics Announces Strategic Partner Takeda Exercises Option to Co-Develop and Co-Commercialize DNL593 (PTV:PGRN)

Denali (DNLI) announces wider-than-expected loss per share for third-quarter 2021. Nonetheless, its shares rise following the announcement.

Denali (DNLI) Stock Up Despite Wider-Than-Expected Q3 Loss

Denali Therapeutics Inc. (DNLI) delivered earnings and revenue surprises of -35.29% and -78.45%, respectively, for the quarter ended September 2021. Do the numbers hold clues to what lies ahead for the stock?

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

SOUTH SAN FRANCISCO, Calif., Nov. 04, 2021 (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, 2021, and provided business highlights.

Denali Therapeutics Reports Third Quarter 2021 Financial Results and Business Highlights

Denali Therapeutics Inc (NASDAQ: DNLI) announced data from the Phase 1 trial evaluating DNL343, eIF2B activator, in 95 healthy volunteers. DNL343 was generally well tolerated for up to 14 days of dosing, with robust distribution in the central nervous system and predictable dose-related increases in DNL343 exposure with a PK profile supporting once-daily dosing.

Denali Highlights Encouraging Early Data, Update For Amyotrophic Lateral Sclerosis Program

SOUTH SAN FRANCISCO, Calif., Oct. 06, 2021 (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 announced positive Phase 1 clinical results and regulatory progress for two investigational small molecule therapeutics in development for the treatment of amyotrophic lateral sclerosis (ALS) at the 2021 Annual Northeast ALS (NEALS) Meeting being held virtually, October 6-7.

Denali Therapeutics Announces Positive Clinical Results and Regulatory Progress for Development Programs in Amyotrophic Lateral Sclerosis (ALS)

SOUTH SAN FRANCISCO, Calif., Sept. 29, 2021 (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 announced upcoming presentations at the 2021 Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting being held virtually, October 6-7.

Denali Therapeutics Announces Upcoming Presentations on EIF2B Activator DNL343 and RIPK1 Inhibitor SAR443820/DNL788 at the 2021 Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting

Proven commercial leader with broad global experience in building and running commercial organizations and successfully launching products for people with neurological and rare diseases Proven commercial leader with broad global experience in building and running commercial organizations and successfully launching products for people with neurological and rare diseases

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