Denali Therapeutics Inc. (DNLI)
| Market Cap | 3.18B |
| Revenue (ttm) | n/a |
| Net Income (ttm) | -512.54M |
| Shares Out | 158.68M |
| EPS (ttm) | -2.97 |
| PE Ratio | n/a |
| Forward PE | n/a |
| Dividend | n/a |
| Ex-Dividend Date | n/a |
| Volume | 1,082,248 |
| Open | 19.97 |
| Previous Close | 19.94 |
| Day's Range | 19.84 - 20.44 |
| 52-Week Range | 12.58 - 23.77 |
| Beta | 1.10 |
| Analysts | Strong Buy |
| Price Target | 34.33 (+71.14%) |
| Earnings Date | May 6, 2026 |
About DNLI
Denali Therapeutics Inc., a biopharmaceutical company, discovers and develops therapeutics to treat neurodegenerative and lysosomal storage diseases. The company develops Eclitasertib (SAR443122/DNL758) RIPK1 inhibitor program for peripheral inflammatory diseases; BIIB122/DNL151 LRRK2 inhibitor program for Parkinson's disease; TAK-594/DNL593 program for frontotemporal dementia-granulin; DNL126 program for MPS IIIA (Sanfilippo Syndrome A); and DNL310 Tividenofusp alfa, an enzyme replacement therapy program for MPS II (Hunter Syndrome). Its Enzym... [Read more]
Financial Performance
Financial StatementsAnalyst Forecast
According to 14 analysts, the average rating for DNLI stock is "Strong Buy." The 12-month stock price target is $34.33, which is an increase of 71.14% from the latest price.
News
Takeda Exits Dementia Drug Partnership With Denali Therapeutics - Here's Why
Takeda on Friday notified Denali Therapeutics regarding the termination of their collaboration agreement to co-develop DNL593, a progranulin replacement therapy for frontotemporal dementia.
Denali Therapeutics Regains Full Rights to Investigational Therapy DNL593 (PTV:PGRN) for GRN-related Frontotemporal Dementia (FTD-GRN)
SOUTH SAN FRANCISCO, Calif., April 03, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that it has received notification from Takeda of its decision to terminate the c...
Denali Therapeutics Transcript: Study update
AVLAYAH received accelerated FDA approval as the first enzyme replacement therapy to cross the blood-brain barrier for Hunter syndrome, showing robust biomarker normalization and clinical improvements in both CNS and peripheral disease. The launch targets 75% of the U.S. treated population, with global expansion planned and a strong foundation for future pipeline growth.
Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)
SOUTH SAN FRANCISCO, Calif., March 25, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval for...
Denali Therapeutics Transcript: Stifel 2026 Virtual CNS Forum
2026 is set as a transformative year with the expected approval and launch of tividenofusp alfa for Hunter syndrome, while key pipeline programs in Sanfilippo, Pompe, and Alzheimer's are advancing toward major data readouts and filings by 2027. The company is leveraging its transferrin receptor platform to expand its portfolio and maintain a competitive edge through engineering innovation.
Denali Therapeutics Transcript: Leerink Global Healthcare Conference 2026
A pivotal FDA decision for tividenofusp alfa in Hunter syndrome is imminent, with strong biomarker and clinical data supporting approval. Commercial and pipeline strategies are robust, leveraging a differentiated brain delivery platform and recent financing to expand into multiple rare and neurodegenerative diseases.
FDA reversals leave investors worrying about the fates of other experimental drugs
The FDA in the past year has denied or discouraged applications of at least eight new drugs, according to RTW Investments. The agency initially refused to review Moderna's flu shot before reversing co...
Denali Therapeutics Transcript: TD Cowen 46th Annual Health Care Conference
2026 is set to be transformative, with a major regulatory milestone for Hunter syndrome, key data readouts in Parkinson’s and FTD, and commercial launch preparations well underway. Robust clinical data, global expansion plans, and a strong financial position underpin growth.
Denali Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights
SOUTH SAN FRANCISCO, Calif., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the fourth quarter and full year ended December 31, 2025, an...
Denali Therapeutics Transcript: Study update
New data from enzyme transport vehicle programs show sustained biomarker reductions and clinical improvements in Hunter syndrome and MPS IIIA, with robust safety and efficacy signals. Preclinical and early clinical results in Pompe disease support further development. TIVI is on track for launch, and DNL126 may seek accelerated approval in 2027.
Denali Therapeutics Presents Enzyme TransportVehicle™ Progress Across Three Clinical Programs for Treatment of Lysosomal Storage Disorders at 2026 WORLDSymposium™
SOUTH SAN FRANCISCO, Calif., Feb. 05, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced data from programs in Hunter syndrome (mucopolysaccharidosis type II, MPS II), Sa...
Denali Therapeutics To Host Webcast Highlighting Presentations on Enzyme TransportVehicle™ Programs at the 2026 WORLDSymposium™
SOUTH SAN FRANCISCO, Calif., Feb. 02, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that management will host a live webcast to review presentations on its Enzyme Tr...
Denali Therapeutics Announces Data Presentations on Enzyme TransportVehicle™ Programs for Hunter Syndrome, Sanfilippo Syndrome Type A and Pompe Disease at Upcoming 2026 WORLDSymposium™
SOUTH SAN FRANCISCO, Calif., Jan. 29, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced the presentation of clinical and preclinical data from its Enzyme TransportVehicl...
Denali Therapeutics Transcript: 44th Annual J.P. Morgan Healthcare Conference
The conference highlighted a robust pipeline leveraging TransportVehicle technology for brain and systemic delivery, with first approval for Hunter syndrome expected in April. Multiple rare and neurodegenerative disease programs are advancing, supported by strong clinical data, a premium pricing strategy, and efficient commercial planning.
The New England Journal of Medicine Publishes Phase 1/2 Study of Denali Therapeutics' Tividenofusp Alfa (DNL310) for Hunter Syndrome (MPS II)
SOUTH SAN FRANCISCO, Calif., Dec. 30, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced the publication of results from the open-label Phase 1/2 clinical trial of its in...
Denali Therapeutics Announces Pricing of Public Offering of Common Stock and Pre-Funded Warrants
SOUTH SAN FRANCISCO, Calif., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI) today announced the pricing of its underwritten public offering of 9,142,857 shares of its common...
Denali Therapeutics Announces Proposed Offering of Common Stock and Pre-Funded Warrants
SOUTH SAN FRANCISCO, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI) today announced that it intends to offer and sell $200 million of shares of its common stock and,...
Denali Therapeutics Transcript: Investor Day 2025
The company is advancing its Tivi platform to deliver biotherapeutics across the blood-brain barrier and body, targeting rare diseases and neurodegeneration. Near-term launches of Tivi and DNL126 are expected to drive over $1 billion in revenue, supported by robust internal manufacturing and strategic partnerships.
Denali Therapeutics and Royalty Pharma Announce $275 Million Royalty Funding Agreement
SOUTH SAN FRANCISCO, Calif. and NEW YORK, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) and Royalty Pharma plc (Nasdaq: RPRX) today announced a $275 million synthetic royal...
Denali Therapeutics Transcript: Jefferies London Healthcare Conference 2025
The session highlighted advances in blood-brain barrier transport technology, with Hunter and Sanfilippo programs progressing toward regulatory filings and commercial launches. The pipeline includes Alzheimer's, Parkinson's, and FTD dementia assets, with a focus on leveraging platform synergies and global expansion.
Denali Therapeutics Transcript: Stifel 2025 Healthcare Conference
Significant pipeline progress includes regulatory filings for Hunter, Sanfilippo, and Alzheimer's programs, with innovative transport vehicle technology enabling CNS drug delivery. Launch preparations are underway, and safety engineering differentiates the platform, while global market access and future partnerships are being strategically considered.
Denali Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights
SOUTH SAN FRANCISCO, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the third quarter ended September 30, 2025, and provided bus...
FDA Delays Decision Date For Denali Therapeutics' Lead Drug Candidate
The U.S. Food and Drug Administration extended on Monday Denali Therapeutics Inc.'s (NASDAQ:DNLI) review timeline of the Biologics License Application (BLA), seeking accelerated approval of tividenofu...
Denali Therapeutics Announces FDA Review Extension of BLA for Tividenofusp Alfa for the Treatment of MPS II (Hunter Syndrome)
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...
Denali Therapeutics Transcript: Baird Global Healthcare Conference 2025
The company is advancing a modular transport vehicle platform to deliver therapeutics across the blood-brain barrier, with lead programs in Hunter and Sanfilippo syndromes showing strong biomarker and clinical improvements. Regulatory progress is robust, with a BLA under priority review and a diversified pipeline targeting neurodegenerative and lysosomal diseases.