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 |
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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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Tividenofusp alfa BLA review process for accelerated approval for MPS II continues with productive engagement with the FDA; commercial launch preparations on trackDNL126 Phase 1/2 study enrollment completed, supporting an accelerated approval path in MPS IIIATwo new regulatory applications submitted to initiate clinical studies with DNL628 (OTV:MAPT) for Alzheimer's disease and DNL952 (ETV:GAA) for Pompe diseaseTim Van Hauwermeiren, CEO of argenx, to join Denali's Board of DirectorsCarole Ho, M.D., Chief Medical Officer, departing company; Peter Chin, M.D., assuming role of Acting CMO and Head of DevelopmentDenali to host Investor Day on December 4, 2025 SOUTH SAN FRANCISCO, Calif., Nov. 0
SOUTH SAN FRANCISCO, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced updates to its Board of Directors and executive leadership team. Tim Van Hauwermeiren has been appointed to Denali's Board of Directors. Mr. Van Hauwermeiren is co-founder and Chief Executive Officer of argenx. Carole Ho, M.D., who has served as Denali's Chief Medical Officer and Head of Development since 2015, will be departing to join Eli Lilly and Company as Executive Vice President, and President of Lilly Neuroscience. Peter Chin, M.D., is assuming the role of Acting Chief Medical Officer and Head of Development at Denali. Dr. Chin is a neurologist and joined Denali in
SOUTH SAN FRANCISCO, Calif., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced that the U.S. Food and Drug Administration (FDA) has extended its review timeline of the Biologics License Application (BLA) seeking accelerated approval of tividenofusp alfa for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome. The Prescription Drug User Fee Act (PDUFA) target date has been extended from January 5, 2026, to April 5, 2026. The extension follows Denali's submission of updated clinical pharmacology information in response to an information request from the FDA as part of the standard review process and is not related to
Tividenofusp alfa BLA for Hunter syndrome accepted for priority review and assigned PDUFA target action date of January 5, 2026; company preparing for commercial launchDNL126 accelerated approval path for Sanfilippo syndrome Type A aligned with FDA; Phase 1/2 study nearing completion of enrollment; planning underway for a global Phase 3 confirmatory studyOn track to submit regulatory applications in 2025 to begin clinical testing of one to two additional TransportVehicleTM (TV)-enabled programsPreclinical research on ATV:Abeta program for Alzheimer's disease published in the journal Science SOUTH SAN FRANCISCO, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNL
FDA assigns PDUFA target action date of January 5, 2026, for decision on accelerated approvalTividenofusp alfa is designed to deliver missing enzyme to entire body and cross blood-brain barrier into the brainTividenofusp alfa leads company's broader TransportVehicle™-enabled pipeline SOUTH SAN FRANCISCO, Calif., July 07, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) seeking accelerated approval for tividenofusp alfa for the treatment of Hunter syndrome (mucopolysaccharidoses type II, or MPS II), a rare and progressive genetic disorder. The FD
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
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Tividenofusp alfa BLA review process for accelerated approval for MPS II continues with productive engagement with the FDA; commercial launch preparations on trackDNL126 Phase 1/2 study enrollment completed, supporting an accelerated approval path in MPS IIIATwo new regulatory applications submitted to initiate clinical studies with DNL628 (OTV:MAPT) for Alzheimer's disease and DNL952 (ETV:GAA) for Pompe diseaseTim Van Hauwermeiren, CEO of argenx, to join Denali's Board of DirectorsCarole Ho, M.D., Chief Medical Officer, departing company; Peter Chin, M.D., assuming role of Acting CMO and Head of DevelopmentDenali to host Investor Day on December 4, 2025 SOUTH SAN FRANCISCO, Calif., Nov. 0
SOUTH SAN FRANCISCO, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced updates to its Board of Directors and executive leadership team. Tim Van Hauwermeiren has been appointed to Denali's Board of Directors. Mr. Van Hauwermeiren is co-founder and Chief Executive Officer of argenx. Carole Ho, M.D., who has served as Denali's Chief Medical Officer and Head of Development since 2015, will be departing to join Eli Lilly and Company as Executive Vice President, and President of Lilly Neuroscience. Peter Chin, M.D., is assuming the role of Acting Chief Medical Officer and Head of Development at Denali. Dr. Chin is a neurologist and joined Denali in
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CAMBRIDGE, Mass., Oct. 2, 2023 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, and ProFound™ Therapeutics, a company pioneering the discovery of a vastly expanded human proteome and using its newfound insights to unlock a universe of potential new medicines, today announced that John Lepore, M.D., will join Flagship Pioneering as CEO-Partner, and ProFound as Chief Executive Officer, effective October 16, 2023. Dr. Lepore joins ProFound after 17 years at GSK where he had extensive experience leading large international R&D organizations across diverse t
ProFound™ Therapeutics, a company pioneering the discovery of a vastly expanded human proteome and using its newfound insights to unlock a universe of potential new medicines, today announced the appointment of Klaus Urbahns, Ph.D., as Chief Scientific Officer. Urbahns will lead the Company's platform and drug discovery and development efforts to advance first-in-class therapeutics leveraging the company's ProFoundry™ Platform. Urbahns brings three decades of robust drug discovery and development experience to ProFound, with a successful track record in discovering and advancing first-in-human medicines from the lab to the clinic. He joins ProFound after 13 years at Merck KGaA, where he m
CAMBRIDGE, Mass., Sept. 11, 2023 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, announced today the appointment of Amanda Kay as Senior Partner and Chief Business Development Officer. In this role, she will be responsible for driving and supporting business development across the Flagship ecosystem, leading the effort to forge strong partnerships between Flagship companies and the biopharma industry. She will also work closely with the Pioneering Medicines unit of Flagship as we continue to invest in and grow our corporate alliance strategy. "Partner
CAMBRIDGE, Mass., Aug. 29, 2023 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, announced today that pharma and healthcare leader David Khougazian is joining as Growth Partner. In this role, he will help scale and grow several Flagship-founded companies, working together with leaders at Flagship and its ecosystem of companies on organizational development, long-term strategy, financing, and business development. Khougazian joins Flagship from Sanofi where he spent over two decades most recently leading Sanofi's engagement in global emerging markets inc
CAMBRIDGE, Mass., Aug. 14, 2023 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, and Ampersand Biomedicines, a company programming smarter medicines that act specifically at the site of disease and nowhere else, today announced that Jason Gardner, Ph.D., has joined Flagship Pioneering as CEO-Partner, and Ampersand as Chief Executive Officer and member of its Board of Directors. Gardner brings more than two decades of leadership experience across pharmaceutical and biotechnology companies, with deep expertise in drug discovery and development, and a succ
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