Denali Therapeutics Inc., a biopharmaceutical company, discovers and develops therapeutic candidates for neurodegenerative diseases in the United States. The company offers leucine-rich repeat kinase 2 (LRRK2) inhibitor product candidates, including DNL201 that has completed Phase 1b clinical trials and DNL151, which are in Phase 1 and Phase 1b clinical trials for Parkinson's disease. It is also developing receptor interacting serine/threonine protein kinase 1 (RIPK1) product candidates, such as DNL747, a selective and brain-penetrant small molecule RIPK1 inhibitor product candidate that is in Phase 1b clinical trial for Alzheimer's disease and amyotrophic lateral sclerosis (ALS). In addition, the company develops enzyme transport vehicle: iduronate 2-sulfatase, an enzyme replacement therapy program for MPS II, a lysosomal storage disorder; antibody transport vehicle (ATV): alpha-synuclein (aSyn) program, a protein that spreads throughout the brain in Parkinson's disease; ATV: triggering receptor expressed in myeloid cells 2, a therapeutic candidate designed to rescue microglial function in Alzheimer's disease; and ATV: Tau, a therapeutic targeting the spreading of Tau. Denali Therapeutics Inc. has collaboration agreement with Takeda Pharmaceutical Company and Genentech, Inc., Sanofi, F-star Gamma Limited, F-star Biotechnologische Forschungs-Und Entwicklungsges M.B.H, F-star Biotechnology Limited, SIRION Biotech GmbH, Genzyme Corporation, Harvard University, the Michael J. Fox Foundation, Centogene, and MedGenome Labs Private Ltd; and a research and option agreement with Secarna Pharmaceuticals GmbH & Co. KG. to develop antisense therapies in the field of neurodegenerative diseases. The company was formerly known as SPR Pharma Inc. and changed its name to Denali Therapeutics Inc. in March 2015. Denali Therapeutics Inc. was incorporated in 2013 and is headquartered in South San Francisco, California.
IPO Year: 2017
Exchange: NASDAQ
Website: denalitherapeutics.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 4/10/2025 | Neutral → Overweight | Cantor Fitzgerald | |
| 3/7/2025 | $41.00 → $33.00 | Overweight | Morgan Stanley |
| 2/11/2025 | $31.00 | Buy | Deutsche Bank |
| 1/7/2025 | $31.00 | Outperform | Robert W. Baird |
| 1/3/2025 | Outperform | William Blair | |
| 12/16/2024 | $37.00 | Hold → Buy | Stifel |
| 10/10/2024 | Mkt Perform | Raymond James | |
| 10/7/2024 | Overweight → Neutral | Cantor Fitzgerald | |
| 12/13/2023 | $32.00 | Buy | Citigroup |
| 11/20/2023 | $28.00 | Overweight | JP Morgan |
Cantor Fitzgerald upgraded Denali Therapeutics from Neutral to Overweight
Morgan Stanley resumed coverage of Denali Therapeutics with a rating of Overweight and set a new price target of $33.00 from $41.00 previously
Deutsche Bank initiated coverage of Denali Therapeutics with a rating of Buy and set a new price target of $31.00
Robert W. Baird initiated coverage of Denali Therapeutics with a rating of Outperform and set a new price target of $31.00
William Blair initiated coverage of Denali Therapeutics with a rating of Outperform
Stifel upgraded Denali Therapeutics from Hold to Buy and set a new price target of $37.00
Raymond James resumed coverage of Denali Therapeutics with a rating of Mkt Perform
Cantor Fitzgerald downgraded Denali Therapeutics from Overweight to Neutral
Citigroup initiated coverage of Denali Therapeutics with a rating of Buy and set a new price target of $32.00
JP Morgan resumed coverage of Denali Therapeutics with a rating of Overweight and set a new price target of $28.00
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SOUTH SAN FRANCISCO, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today reported financial results for the first quarter ended March 31, 2025, and provided business highlights. "The completion of our BLA submission for tividenofusp alfa represents a pivotal milestone—not only in our commitment to delivering a potentially transformative therapy to individuals living with Hunter syndrome, but also in Denali's evolution as a fully integrated, late-stage development and commercial organization," said Ryan Watts, Ph.D., CEO of Denali Therapeutics. "We are now preparing for commercial launch in late 2025 or early 2026. If approved, tividenofusp alfa would be t
Rolling submission of BLA initiated for tividenofusp alfa; preparations ongoing for potential U.S. commercial launch in late 2025 or early 2026Alignment through recent interactions with CDER on path to accelerated approval and conversion to full approval for tividenofusp alfaProductive collaboration continues under START for an accelerated development and approval path for DNL126 SOUTH SAN FRANCISCO, Calif., April 02, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), today announced that the company's initiation of a rolling submission of a biologics license application (BLA) for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome (MPS II) has bee
SOUTH SAN FRANCISCO, Calif., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today reported financial results for the fourth quarter and year ended December 31, 2024, and provided business highlights. "In 2024, we made significant strides across our portfolio, particularly with our Enzyme Transport Vehicle (ETV) programs, achieving a path to a potential accelerated approval for our lead program in MPS II," said Ryan Watts, Ph.D., CEO of Denali. "In 2025, we will continue expanding our capabilities as we prepare for our first potential product launch of tividenofusp alfa. In addition, we are prioritizing opportunities to expand and accelerate our TV portfolio and a
Long-term data demonstrate that robust reductions and normalization in key biomarkers from baseline were maintained over time with continued improvement in hearing, cognition and adaptive behaviorLong-term safety data with median follow-up of two years, and out to more than four years, demonstrate that tividenofusp alfa was generally well tolerated Regulatory submission for accelerated approval is planned for early 2025; U.S. launch preparation is ongoing to deliver tividenofusp alfa to families with MPS II in late 2025 or early 2026 SOUTH SAN FRANCISCO, Calif., Feb. 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), today announced the primary analysis of the Phase 1/2
SOUTH SAN FRANCISCO, Calif., Jan. 30, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), today announced upcoming oral (platform) and poster presentations at the 21st Annual WORLDSymposium™, which will be held February 3-7, 2025, in San Diego, California. The oral presentation includes clinical results related to its Hunter syndrome (MPS II) investigational therapeutic, tividenofusp alfa (DNL310). Tividenofusp alfa is enabled by the Denali TransportVehicle™ platform, which is designed to effectively deliver enzyme, oligonucleotide, or antibody therapeutics to all tissues in the body, including the brain by crossing the blood-brain barrier. The presentation schedule at WORLDS
FDA Breakthrough Therapy Designation received for tividenofusp alfa for Hunter syndrome (MPS II); on track to submit biologics license application (BLA) in early 2025Preparing for commercial launch of tividenofusp alfa for Hunter syndrome in late 2025 or early 2026Enable accelerated approval pathway for DNL126 for Sanfilippo syndrome Type A (MPS IIIA)Expand and advance portfolio of multiple TransportVehicleTM (TV) enabled programs for delivery of enzyme, oligonucleotide, and antibody therapeutics for rare and common diseases SOUTH SAN FRANCISCO, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), today announced key anticipated milestones for 2025 across its
SOUTH SAN FRANCISCO, Calif., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tividenofusp alfa (DNL310) for the treatment of individuals with Hunter syndrome (MPS II). This designation is in addition to Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation, all previously granted by the FDA for tividenofusp alfa in Hunter syndrome. Denali expects to submit a Biologics License Application (BLA) for tividenofusp alfa in early 2025 for regulatory review under the accelerated approval pathway. "FDA Breakthrough Therapy De
Primary endpoint of overall function (ALSFRS-R) and survival, and key secondary endpoints of muscle strength and respiratory function, were not met at 24 weeksOverall, DNL343 was found to be safe and well toleratedAdditional analyses, including neurofilament light (NfL) and other fluid biomarkers, prespecified sub-group analyses and analyses from the active treatment extension period are expected later in 2025 SOUTH SAN FRANCISCO, Calif., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced topline results from an analysis of Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating eIF2B agonist DNL343 in the treatment of amyotrophic lateral scle
SOUTH SAN FRANCISCO, Calif., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced initiation of dosing in a global Phase 2a clinical study, BEACON, of the investigational drug leucine-rich repeat kinase 2 (LRRK2) inhibitor BIIB122 (DNL151) in participants with LRRK2-associated Parkinson's disease (LRRK2-PD). LRRK2 inhibition is a potential therapeutic approach that may slow progression of Parkinson's disease by targeting underlying lysosomal dysfunction implicated in this disease. The Phase 2a study is intended to evaluate safety and biomarkers associated with oral daily dosing of BIIB122 in approximately 50 participants with Parkinson's disease and LRR
Recent successful meeting with the FDA provides path to file for accelerated approval and subsequent conversion to full approvalPlan to submit biologics license application (BLA) early in 2025 under the accelerated approval pathwayNew Phase 1/2 data will be presented this week at SSIEM 2024 demonstrating robust and durable biomarker responses and positive effects on clinical outcomes SOUTH SAN FRANCISCO, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced the outcome of a recent successful meeting with the Center for Drug Evaluation and Research (CDER) division of the U.S. Food and Drug Administration (FDA) providing a path to filing a biologi