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DNLI Overview

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$
0.000
0.000(0.000%)
At close
0.000(0.000%)Aft-market
ET
$
0.000
0.000(0.000%)
At close
0.000(0.000%)Aft-market
ET
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Intellectia

Loading chart...

High
20.450
Open
19.700
VWAP
20.11
Vol
574.24K
Mkt Cap
3.13B
Low
19.680
Amount
11.55M
EV/EBITDA(TTM)
--
Total Shares
158.59M
EV
2.27B
EV/OCF(TTM)
--
P/S(TTM)
--
Denali Therapeutics Inc. is a biopharmaceutical company. The Company is focused on developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases. It has developed a technology, called the TransportVehicle (TV), to address the BBB challenge. Its advanced TV-enabled program is tividenofusp alfa (DNL310, ETV:IDS) for the potential treatment of mucopolysaccharidosis II (MPS II or Hunter syndrome). Its TV-enabled clinical development portfolio also includes DNL126 (ETV:SGSH) for MPS IIIA (Sanfilippo syndrome) and DNL593 (PTV:PGRN) for frontotemporal dementia-granulin (FTD-GRN). Its small-molecule clinical development portfolio includes BIIB122/DNL151 (small molecule LRRK2 inhibitor) for Parkinson’s disease; and DNL343 (small molecule eIF2B activator) for amyotrophic lateral sclerosis (ALS). It is also exploring programs in oncology, inflammation, and other diseases.
Show More

Events Timeline

(ET)
2026-01-06
08:30:00
Denali Therapeutics Announces Key Milestones and Priorities for 2026
select
2025-12-30 (ET)
2025-12-30
08:20:00
Denali Therapeutics Publishes Hunter Syndrome Therapy Trial Results
select
2025-12-10 (ET)
2025-12-10
06:10:00
Goldman Sachs and Others Manage IPO Deal Range of $17.00-$18.00
select

News

Benzinga
9.5
03-09Benzinga
Relmada Therapeutics Shares Surge 40.8% on Promising Trial Data
  • Market Decline: U.S. stocks fell broadly on Monday, with the Dow Jones index dropping around 650 points, indicating investor concerns about economic outlook which may impact consumer spending and overall market confidence.
  • Relmada Stock Surge: Shares of Relmada Therapeutics Inc. soared 40.8% to $6.27 during Monday's session, driven by the release of promising interim data from its Phase 2 trial of NDV-01 for treating non-muscle invasive bladder cancer.
  • Clinical Trial Results: The 12-month interim data revealed a complete response rate of 76%, with an impressive 80% in the BCG-unresponsive patient population, providing strong support for Relmada's treatment approach and potentially enhancing market acceptance.
  • Positive Market Reaction: The favorable feedback from clinical data has led to optimistic investor sentiment regarding Relmada's future prospects, not only boosting the company's stock price but also likely attracting more investor interest in its ongoing research and development efforts.
CNBC
9.0
03-06CNBC
FDA Rejects Multiple Experimental Drug Applications, Raising Investor Concerns
  • FDA Drug Rejections: The U.S. FDA has denied or discouraged applications for at least eight drugs over the past year, including UniQure's gene therapy for Huntington's disease, indicating regulatory uncertainty that could impact future treatment approvals.
  • Investor Concerns Rise: Investors are increasingly wary as the FDA appears to change its standards for drug applications, particularly for treatments targeting hard-to-treat diseases, leading to diminished confidence in ongoing development efforts.
  • Changing Regulatory Standards: The FDA's request for UniQure to conduct new placebo-controlled trials contradicts previous guidance, highlighting inconsistencies in the agency's approval process that may create uncertainty for companies in their R&D efforts.
  • Uncertain Future Outlook: Analysts warn that if the FDA does not approve Denali Therapeutics' drug for Hunter syndrome, it could further undermine other companies' confidence in running open-label studies, potentially stifling innovation across the industry.
Newsfilter
7.0
03-06Newsfilter
FDA Drug Approval Uncertainty Intensifies
  • Drug Applications Denied: According to RTW Investments, the FDA has denied or discouraged applications for at least eight new drugs over the past year, including gene therapies for Huntington's and Hunter syndrome, raising investor concerns about the prospects for other drugs in the pipeline.
  • Changing Regulatory Standards: The FDA's request for UniQure to conduct new placebo-controlled studies contradicts previous guidance, leading investors to doubt the agency's consistency and fearing that this could jeopardize future treatment approvals.
  • Negative Market Reaction: Stocks of several biotech companies have declined following FDA rejections, with analysts noting a stark conflict between the FDA's recent decisions and the flexibility promised by its leadership, causing investors to lose confidence in companies relying on FDA leniency.
  • Uncertain Future Outlook: Although FDA officials assert that biomarkers can lead to accelerated approvals, investors remain confused about the agency's approval standards, particularly for drugs targeting rare diseases, making future approval pathways increasingly uncertain.
seekingalpha
8.5
02-26seekingalpha
Denali Therapeutics Reports Q4 Results and Stock Offering
  • Earnings Report: Denali Therapeutics reported a Q4 GAAP EPS of -$0.73, aligning with market expectations, indicating stability in financial transparency despite ongoing losses.
  • Cash Reserves: As of December 31, 2025, Denali's cash, cash equivalents, and marketable securities totaled approximately $966.2 million, providing a solid liquidity foundation for future R&D and operational needs.
  • Stock Offering Announcement: Denali Therapeutics announced a proposed stock offering priced at $17.50 per share, aiming to raise $200 million, which will support its ongoing clinical trials and business expansion efforts.
  • Market Reaction: The news of the stock offering may exert short-term pressure on the stock price; however, the influx of capital is expected to facilitate advancements in the company's research on neurodegenerative diseases in the long run.
Globenewswire
8.5
02-19Globenewswire
Shifting Trends in Biotechnology Mergers and Acquisitions
  • Evolving M&A Strategies: Pharmaceutical companies are increasingly prioritizing clinical-stage and late-stage programs, particularly those supported by clear human data, indicating a market preference for mature assets that demonstrate safety and efficacy.
  • OT-101 IP Expansion: Oncotelic Therapeutics recently announced the expansion of international intellectual property coverage for OT-101, enhancing protection across neurology, oncology, and CNS drug delivery technologies, thereby solidifying its market position in these areas.
  • Importance of Clinical Validation: Biopharmaceutical deal activity reflects a growing preference for programs that have achieved clinical validation, particularly in oncology and CNS, highlighting investors' focus on reducing development risks associated with drug discovery.
  • Cross-Applicability Platforms: Oncotelic's TGF-β modulation strategy illustrates its broad application potential across oncology and neurological diseases, indicating the company's pursuit of greater market opportunities across multiple indications, thereby enhancing its long-term strategic value.
Newsfilter
9.0
02-10Newsfilter
REGENXBIO Faces FDA Challenges for Gene Therapy Approval
  • FDA Response Letter Issued: REGENXBIO's shares fell after receiving a response letter from the FDA regarding its Hunter syndrome gene therapy, indicating regulatory concerns about trial design that could delay the approval timeline.
  • Trial Design Concerns: The FDA's questioning of the trial design may impact the efficacy assessment of the therapy, negatively affecting REGENXBIO's market outlook and increasing uncertainty for investors.
  • Approval Timeline Delayed: Due to the FDA's feedback, REGENXBIO may need to reevaluate its clinical trial plans, which will push back the originally scheduled approval timeline and affect the company's future revenue expectations.
  • Negative Market Reaction: The stock price decline following the FDA's response letter reflects market concerns about REGENXBIO's future direction, potentially leading to decreased investor confidence and impacting its ability to raise funds.
Wall Street analysts forecast DNLI stock price to rise
10 Analyst Rating
Wall Street analysts forecast DNLI stock price to rise
10 Buy
0 Hold
0 Sell
Strong Buy
Current: 0.000
sliders
Low
25.00
Averages
32.78
High
40.00
Current: 0.000
sliders
Low
25.00
Averages
32.78
High
40.00
BTIG
Buy
maintain
$32 -> $36
AI Analysis
2026-03-02
Reason
BTIG
Price Target
$32 -> $36
AI Analysis
2026-03-02
maintain
Buy
Reason
BTIG raised the firm's price target on Denali Therapeutics to $36 from $32 and keeps a Buy rating on the shares. The company has established a clear path to get complex drugs approved and can now leverage their expertise and the quality FDA relationship they have built to fast-track the pipeline, the analyst tells investors in a research note.
Stifel
Paul Matteis
Buy
downgrade
$37 -> $34
2026-02-27
Reason
Stifel
Paul Matteis
Price Target
$37 -> $34
2026-02-27
downgrade
Buy
Reason
Stifel analyst Paul Matteis lowered the firm's price target on Denali Therapeutics to $34 from $37 and keeps a Buy rating on the shares.
Unlock Full Analyst Thesis, Get the complete breakdown of rating reason for DNLI
Unlock Now

Valuation Metrics

The current forward P/E ratio for Denali Therapeutics Inc (DNLI.O) is -5.51, compared to its 5-year average forward P/E of -12.20. For a more detailed relative valuation and DCF analysis to assess Denali Therapeutics Inc's fair value, Click here.

Forward PE

The forward P/E ratio is a valuation metric that divides a company's current stock price by its estimated future earnings per share over the next 12 months.
StronglyUndervaluedUndervaluedFairOvervaluedStronglyOvervalueddotted line Image
N/A
5Y Average PE
-12.20
Current PE
-5.51
Overvalued PE
-3.68
Undervalued PE
-20.72

Forward EV/EBITDA

The forward EV/EBITDA ratio is a valuation metric that divides a company's enterprise value (EV) by its estimated future earnings before interest, taxes, depreciation, and amortization (EBITDA) over the next 12 months.
StronglyUndervaluedUndervaluedFairOvervaluedStronglyOvervalueddotted line Image
N/A
5Y Average EV/EBITDA
-9.18
Current EV/EBITDA
-3.14
Overvalued EV/EBITDA
-1.59
Undervalued EV/EBITDA
-16.77

Forward PS

The forward P/S ratio is a valuation metric that divides a company's current stock price by its estimated future sales (or revenue) per share over the next 12 months.
StronglyUndervaluedUndervaluedFairOvervaluedStronglyOvervalueddotted line Image
5Y Average PS
71.68
Current PS
199.57
Overvalued PS
121.28
Undervalued PS
22.08

Financials

AI Analysis
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Quarterly

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Whales Holding DNLI

C
Crestline Investors Inc.
Holding
DNLI
+11.28%
3M Return
A
Artal Group S.A.
Holding
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+7.41%
3M Return
B
Bluebox Asset Management Uk Ltd.
Holding
DNLI
+3.54%
3M Return
C
Cercano Management LLC
Holding
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-2.25%
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Baker Bros. Advisors LP
Holding
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-8.55%
3M Return

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Frequently Asked Questions

What is Denali Therapeutics Inc (DNLI) stock price today?

The current price of DNLI is 20.19 USD — it has increased 2.23

What is Denali Therapeutics Inc (DNLI)'s business?

Denali Therapeutics Inc. is a biopharmaceutical company. The Company is focused on developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases. It has developed a technology, called the TransportVehicle (TV), to address the BBB challenge. Its advanced TV-enabled program is tividenofusp alfa (DNL310, ETV:IDS) for the potential treatment of mucopolysaccharidosis II (MPS II or Hunter syndrome). Its TV-enabled clinical development portfolio also includes DNL126 (ETV:SGSH) for MPS IIIA (Sanfilippo syndrome) and DNL593 (PTV:PGRN) for frontotemporal dementia-granulin (FTD-GRN). Its small-molecule clinical development portfolio includes BIIB122/DNL151 (small molecule LRRK2 inhibitor) for Parkinson’s disease; and DNL343 (small molecule eIF2B activator) for amyotrophic lateral sclerosis (ALS). It is also exploring programs in oncology, inflammation, and other diseases.

What is the price predicton of DNLI Stock?

Wall Street analysts forecast DNLI stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for DNLI is32.78 USD with a low forecast of 25.00 USD and a high forecast of 40.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.

What is Denali Therapeutics Inc (DNLI)'s revenue for the last quarter?

Denali Therapeutics Inc revenue for the last quarter amounts to 0.00 USD, decreased

What is Denali Therapeutics Inc (DNLI)'s earnings per share (EPS) for the last quarter?

Denali Therapeutics Inc. EPS for the last quarter amounts to -0.73 USD, increased 8.96

How many employees does Denali Therapeutics Inc (DNLI). have?

Denali Therapeutics Inc (DNLI) has 503 emplpoyees as of March 20 2026.

What is Denali Therapeutics Inc (DNLI) market cap?

Today DNLI has the market capitalization of 3.13B USD.