Denali TherapeuticsDNLI
DNLI
About: Denali Therapeutics Inc is a biotechnology company that is engaged in developing and discovering therapeutics to defeat neurodegeneration disease. The company's development programs include the LRRK2 Inhibitor Program, which develops brain penetrant small molecule LRRK2 inhibitor product candidates for Parkinson's disease. Its key products include DNL201, DNL151, DNL747, ATV (Antibody Transport Vehicle), ETV (Enzyme Transport Vehicle), and others.
Employees: 443
0
Funds holding %
of 7,312 funds
0
Analysts bullish %
of 4 analysts
Fund manager confidence
Based on 2025 Q1 regulatory disclosures by fund managers ($100M+ AUM)
65% more call options, than puts
Call options by funds: $848K | Put options by funds: $515K
2.61% more ownership
Funds ownership: 88.88% [Q4 2024] → 91.49% (+2.61%) [Q1 2025]
3% more first-time investments, than exits
New positions opened: 36 | Existing positions closed: 35
1% less funds holding
Funds holding: 222 [Q4 2024] → 220 (-2) [Q1 2025]
9% less repeat investments, than reductions
Existing positions increased: 73 | Existing positions reduced: 80
31% less capital invested
Capital invested by funds: $2.61B [Q4 2024] → $1.81B (-$800M) [Q1 2025]
50% less funds holding in top 10
Funds holding in top 10: 2 [Q4 2024] → 1 (-1) [Q1 2025]
Research analyst outlook
4 Wall Street Analysts provided 1 year price targets over the past 3 months
Low target
$27
86%
upside
Avg. target
$30
103%
upside
High target
$32
120%
upside
4 analyst ratings
4 positive
100%
0 neutral
0%
0 negative
0%
B of A Securities Tazeen Ahmad | 86%upside $27 | Buy Maintained | 19 May 2025 |
Baird Joel Beatty | 100%upside $29 | Outperform Maintained | 8 May 2025 |
Wedbush Laura Chico | 107%upside $30 | Outperform Maintained | 7 May 2025 |
HC Wainwright & Co. Andrew Fein | 120%upside $32 | Buy Maintained | 7 May 2025 |
Financial journalist opinion
Positive
Zacks Investment Research
3 days ago
DNLI's BLA for Hunter Syndrome Drug Gets FDA's Priority Review
Denali's lead drug for Hunter syndrome wins FDA Priority Review, marking a key step toward commercial-stage status.
Neutral
GlobeNewsWire
4 days ago
Denali Therapeutics Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Tividenofusp Alfa for Hunter Syndrome (MPS II)
FDA assigns PDUFA target action date of January 5, 2026, for decision on accelerated approval Tividenofusp alfa is designed to deliver missing enzyme to entire body and cross blood-brain barrier into the brain Tividenofusp 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.
Positive
Zacks Investment Research
1 month ago
Why Is Denali Therapeutics (DNLI) Up 0.7% Since Last Earnings Report?
Denali Therapeutics (DNLI) reported earnings 30 days ago. What's next for the stock?
Negative
Zacks Investment Research
2 months ago
Denali Q1 Loss Wider Than Expected, Hunter Syndrome Drug in Focus
DNLI reports a wider-than-expected loss for the first quarter of 2025. Denali submits a BLA for tividenofusp alfa under the FDA?
Neutral
GlobeNewsWire
2 months ago
Denali Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights Including Completion of BLA Rolling Submission for Tividenofusp Alfa for Hunter Syndrome
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.
Positive
Zacks Investment Research
2 months ago
5 Drug/Biotech Stocks Likely to Outperform Q1 Earnings Estimates
Let us look at some drug/biotech stocks, NVO, PCRX, RARE, ACAD and DNLI, which are poised to beat on first-quarter 2025 earnings.
Positive
Zacks Investment Research
3 months ago
DNLI Begins Rolling BLA Submission for Hunter Syndrome Drug, Stock Up
Denali stock up as it begins rolling BLA submission with the FDA for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome.
Neutral
GlobeNewsWire
3 months ago
Denali Therapeutics Announces Initiation of BLA Filing for Accelerated Approval of Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II) and Positive Ongoing Interactions with FDA on DNL126 Through START Program
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 been received by the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA). Denali continues to have regular, collaborative, and productive engagement with CDER and is aligned with CDER on the content of the BLA data package, including the use of cerebrospinal fluid heparan sulfate (CSF HS) as a surrogate endpoint to support an accelerated approval, as well as the full approval conversion path. Denali expects to complete the BLA submission in the first half of May 2025 and continues to prepare for a potential commercial launch in the U.S. in late 2025 or early 2026.
Neutral
Market Watch
3 months ago
Biotech stocks have been hit hard. Why they're a great value now.
Biotech is one of the U.S. stock market's most unloved sectors. But several indicators suggest that a bottom in sentiment could be near, and that's normally a good time to buy.
Positive
Seeking Alpha
3 months ago
Denali Therapeutics: Vast Pipeline, First Approval Up Ahead
Denali Therapeutics' stock has significantly dropped from $100 to $15 since 2021, but the company is now heavily derisked with promising product candidates nearing key milestones. Lead asset DNL310 shows strong biomarker data for Hunter syndrome, with plans for a BLA submission and accelerated approval by Q2 2025. The Biogen partnership for Parkinson's Disease asset DNL151 includes substantial milestone payments and profit-sharing, highlighting its potential impact.
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