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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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
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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
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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