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Aberdeen Group plc Buys 210,835 Shares of Denali Therapeutics Inc. $DNLI

https://www.marketbeat.com/instant-alerts/filing-aberdeen-group-plc-buys-210835-shares-of-denali-therapeutics-inc-dnli-2026-02-19/
Aberdeen Group plc significantly increased its stake in Denali Therapeutics Inc. by 23.4%, acquiring an additional 210,835 shares, bringing its total holdings to 1,113,586 shares valued at $16.17 million. Other institutional investors like Norges Bank, Geode Capital, and Goldman Sachs also showed increased interest, leading to 92.92% institutional ownership. Despite strong institutional buying and a consensus "Buy" rating from analysts with an average price target of $32.27, company insiders, including the CEO, sold shares in early January.

Denali Therapeutics (DNLI) Expected to Announce Earnings on Thursday

https://www.marketbeat.com/instant-alerts/denali-therapeutics-dnli-expected-to-announce-earnings-on-thursday-2026-02-19/
Denali Therapeutics (DNLI) is expected to announce its Q4 2025 earnings before market open on Thursday, February 26th, with analysts forecasting an EPS of ($0.75). The company's stock opened at $19.23, has a market cap of $2.82 billion, and analysts hold a consensus "Buy" rating with an average target price of $32.27. Recent insider sales by CEO Ryan J. Watts and Alexander O. Schuth reduced their holdings, while institutional investors own a significant 92.92% of the company's stock.

Denali Therapeutics Inc. (NASDAQ:DNLI) Receives Consensus Recommendation of "Buy" from Analysts

https://www.marketbeat.com/instant-alerts/denali-therapeutics-inc-nasdaqdnli-receives-consensus-recommendation-of-buy-from-analysts-2026-02-14/
Denali Therapeutics Inc. (NASDAQ:DNLI) has received a consensus "Buy" recommendation from analysts, with an average 12-month price target of $32.27, suggesting significant upside from its current price of $18.77. The company is a clinical-stage biopharmaceutical firm focused on neurodegenerative diseases, utilizing a Blood-Brain Barrier TV platform. Insider trading activity was noted, with CEO Ryan J. Watts and another insider selling shares in early January, though insiders still collectively own a substantial portion of the company.

(DNLI) Risk Channels and Responsive Allocation

https://news.stocktradersdaily.com/news_release/35/DNLI_Risk_Channels_and_Responsive_Allocation_021326050602_1770977162.html
The article analyzes Denali Therapeutics Inc. (NASDAQ: DNLI), identifying a mid-channel oscillation pattern and a significant 62.0:1 risk-reward setup targeting a 17.5% gain versus 0.3% risk. It highlights divergent sentiment across different time horizons and provides three AI-generated trading strategies (Position, Momentum Breakout, Risk Hedging) with specific entry, target, and stop-loss levels. The analysis suggests weak near-term sentiment but strong long-term potential for DNLI.

Assessing Denali Therapeutics (DNLI) Valuation After WORLDSymposium Clinical Updates And Regulatory Progress

https://www.sahmcapital.com/news/content/assessing-denali-therapeutics-dnli-valuation-after-worldsymposium-clinical-updates-and-regulatory-progress-2026-02-10
Denali Therapeutics (DNLI) has garnered attention following its clinical updates at WORLDSymposium and progress on its rare disease pipeline. While recent share price performance shows strong near-term momentum, a discounted cash flow (DCF) analysis by Simply Wall St suggests the stock is undervalued, pointing to a potential upside from its current price of $21.08 compared to an estimated future cash flow value of $32.63. However, investors face risks due to Denali's loss-making profile and long development timelines, with its P/B ratio also indicating a more cautious outlook compared to sector averages.
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Principal Financial Group Inc. Purchases 198,207 Shares of Denali Therapeutics Inc. $DNLI

https://www.marketbeat.com/instant-alerts/filing-principal-financial-group-inc-purchases-198207-shares-of-denali-therapeutics-inc-dnli-2026-02-09/
Principal Financial Group Inc. significantly increased its stake in Denali Therapeutics Inc. by 18.5% in Q3, now owning 1,271,190 shares valued at approximately $18.46 million. This move comes despite recent insider selling by the CEO and another insider, who collectively reduced their ownership by over 10%. Analysts generally hold a positive outlook on Denali Therapeutics, with a consensus "Buy" rating and an average price target of $32.17, though the company remains unprofitable.

Analysts Offer Insights on Healthcare Companies: IQVIA Holdings (IQV), Haemonetics (HAE) and Denali Therapeutics (DNLI)

https://www.theglobeandmail.com/investing/markets/stocks/IQV/pressreleases/86713/analysts-offer-insights-on-healthcare-companies-iqvia-holdings-iqv-haemonetics-hae-and-denali-therapeutics-dnli/
BTIG analysts have issued new ratings for several healthcare companies. David Larsen maintained a Hold rating on IQVIA Holdings (IQV) with a $260.50 average price target. Marie Thibault reiterated a Buy rating on Haemonetics (HAE) with an $88.00 price target. Thomas Shrader maintained a Buy rating on Denali Therapeutics (DNLI) with a $32.00 price target.

Analysts Offer Insights on Healthcare Companies: IQVIA Holdings (IQV), Haemonetics (HAE) and Denali Therapeutics (DNLI)

https://www.theglobeandmail.com/investing/markets/stocks/DNLI/pressreleases/86713/analysts-offer-insights-on-healthcare-companies-iqvia-holdings-iqv-haemonetics-hae-and-denali-therapeutics-dnli/
BTIG analysts have provided ratings for three healthcare companies: IQVIA Holdings (IQV), Haemonetics (HAE), and Denali Therapeutics (DNLI). David Larsen maintained a Hold on IQV, Marie Thibault reiterated a Buy on HAE, and Thomas Shrader maintained a Buy on DNLI. The consensus among analysts ranges from Moderate Buy to Strong Buy for these companies, suggesting potential upside from current levels.

Denali Therapeutics (DNLI) Gets a Buy from Wedbush

https://www.theglobeandmail.com/investing/markets/stocks/DNLI-Q/pressreleases/88573/denali-therapeutics-dnli-gets-a-buy-from-wedbush/
Wedbush analyst Laura Chico maintained a Buy rating on Denali Therapeutics (DNLI) with a $30 price target, highlighting her 10.6% average return and 50.55% success rate. The company, however, reported a GAAP net loss of $126.9 million in its latest quarter, and corporate insider sentiment is negative due to increased share selling. Despite a recent Hold rating from TipRanks–Google, other firms like H.C. Wainwright, Morgan Stanley, and UBS also support a Buy rating for DNLI.

Denali Therapeutics (DNLI) Gets a Buy from Wedbush

https://www.theglobeandmail.com/investing/markets/stocks/DNLI/pressreleases/88573/denali-therapeutics-dnli-gets-a-buy-from-wedbush/
Wedbush analyst Laura Chico maintained a Buy rating on Denali Therapeutics (DNLI) with a $30.00 price target. This aligns with another Buy rating from H.C. Wainwright, despite a recent Hold rating reiterated by Google’s TipRanks. The company reported a quarterly GAAP net loss of $126.9 million, and corporate insider sentiment is negative with increased insider selling.
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Denali Therapeutics (NASDAQ:DNLI) Earns Buy Rating from BTIG Research

https://www.marketbeat.com/instant-alerts/denali-therapeutics-nasdaqdnli-earns-buy-rating-from-btig-research-2026-02-06/
BTIG Research has reissued a "buy" rating on Denali Therapeutics (NASDAQ:DNLI), setting a $32 price target which implies a nearly 60% upside. This aligns with the average analyst consensus of a "Buy" rating and a $32.17 target price from MarketBeat. Shares opened at $20.02, with a market cap of approximately $2.94 billion, and the company reported a recent quarterly EPS of -$0.74, beating estimates.

Trial data track Denali enzyme drugs for rare brain and muscle diseases

https://www.stocktitan.net/news/DNLI/denali-therapeutics-presents-enzyme-transport-vehicle-tm-progress-jf8487mhb7z4.html
Denali Therapeutics (NASDAQ: DNLI) presented clinical and preclinical data for three lysosomal storage disorder programs at the 2026 WORLDSymposium, focusing on its Enzyme TransportVehicle (ETV) platform. Key highlights include maintained CSF and urine heparan sulfate reductions through Week 201 for tividenofusp alfa (DNL310) in Hunter syndrome, an 80% mean CSF HS reduction for DNL126 in Sanfilippo syndrome type A, and preclinical data for DNL952 in Pompe disease. The company anticipates a PDUFA date of April 5, 2026, for tividenofusp alfa and is planning a Phase 3 study for DNL126.

Denali Therapeutics Reports Promising Clinical Trial Data for Tividenofusp Alfa and Other Enzyme Replacement Therapies in Lysosomal Storage Disorders

https://www.quiverquant.com/news/Denali+Therapeutics+Reports+Promising+Clinical+Trial+Data+for+Tividenofusp+Alfa+and+Other+Enzyme+Replacement+Therapies+in+Lysosomal+Storage+Disorders
Denali Therapeutics Inc. has presented promising clinical trial data for its enzyme replacement therapies targeting Hunter syndrome, Sanfilippo syndrome type A, and Pompe disease. Tividenofusp alfa for Hunter syndrome showed significant biomarker reduction and consistent safety, with a target FDA decision date of April 5, 2026. DNL126 for Sanfilippo syndrome also demonstrated substantial biomarker reduction, aiming for a BLA submission in 2027, while DNL952 shows potential for Pompe disease, underscoring the broad applicability of Denali's Enzyme TransportVehicle™ platform in addressing rare diseases.

Denali to outline enzyme delivery to the brain in 2026 WORLDSymposium webcast

https://www.stocktitan.net/news/DNLI/denali-therapeutics-to-host-webcast-highlighting-presentations-on-b9o2reqqcfmt.html
Denali Therapeutics (Nasdaq: DNLI) will host a live webcast on Thursday, February 5, 2026, to discuss presentations previously delivered at the 22nd Annual WORLDSymposium. The webcast will highlight the company's Enzyme TransportVehicle (ETV) programs, focusing on their potential to deliver enzyme replacement therapies across the entire body, including the brain. This event provides further visibility into Denali's platform, following recent positive market reactions to milestones and funding, and will be accessible via their investor website.

Denali Therapeutics To Host Webcast Highlighting Presentations on Enzyme TransportVehicle™ Programs at the 2026 WORLDSymposium™

https://www.manilatimes.net/2026/02/02/tmt-newswire/globenewswire/denali-therapeutics-to-host-webcast-highlighting-presentations-on-enzyme-transportvehicle-programs-at-the-2026-worldsymposium/2269739
Denali Therapeutics Inc. announced it will host a live webcast to discuss presentations on its Enzyme TransportVehicle™ (ETV) programs at the upcoming 22nd Annual WORLD Symposium, taking place from February 2-6, 2026. The webcast, scheduled for Thursday, February 5, 2026, at 12:30 p.m. Pacific Time, will highlight the ETV's potential to deliver enzyme replacement therapies throughout the body, including the brain. Denali aims to advance medicines for neurodegenerative, lysosomal storage, and other serious diseases.
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Denali Therapeutics To Host Webcast Highlighting Presentations on Enzyme TransportVehicle™ Programs at the 2026 WORLDSymposium™

https://www.manilatimes.net/2026/02/02/tmt-newswire/globenewswire/denali-therapeutics-to-host-webcast-highlighting-presentations-on-enzyme-transportvehicle-programs-at-the-2026-worldsymposium/2269739/amp
Denali Therapeutics Inc. (Nasdaq: DNLI) will host a live webcast to discuss presentations on its Enzyme TransportVehicle™ (ETV) programs at the 22nd Annual WORLD Symposium™ held in San Diego, California. The webcast, scheduled for February 5, 2026, at 12:30 p.m. Pacific Time, will highlight the ETV's potential to deliver enzyme replacement therapies throughout the body, including the brain. Denali Therapeutics is a biotechnology company focused on developing biotherapeutics capable of crossing the blood-brain barrier.

AlphaQuest LLC Raises Stake in Denali Therapeutics Inc. $DNLI

https://www.marketbeat.com/instant-alerts/filing-alphaquest-llc-raises-stake-in-denali-therapeutics-inc-dnli-2026-02-02/
AlphaQuest LLC significantly increased its stake in Denali Therapeutics Inc. by 224.1% in Q3, now holding 74,422 shares valued at approximately $1.08 million. This increase in institutional ownership comes amidst mixed but skewed positive Wall Street sentiment, with an average price target of $32.17. However, the article also notes recent material insider sales by the CEO and another insider in early January.

Assessing Denali Therapeutics (DNLI) Valuation As WORLDSymposium Data And FDA Priority Review Draw Closer

https://www.sahmcapital.com/news/content/assessing-denali-therapeutics-dnli-valuation-as-worldsymposium-data-and-fda-priority-review-draw-closer-2026-01-31
Denali Therapeutics (DNLI) is gaining attention due to upcoming WORLDSymposium presentations and an FDA Priority Review, which has contributed to a more than 30% increase in its share price over the past month. While its Price-to-Book ratio of 3.7x appears expensive compared to the broader US Biotechs industry, it is considered good value against a narrower peer group average of 13.6x. The company also shows a fair value estimate of $31.58 according to a DCF model, suggesting it might be undervalued despite significant net losses and clinical risks.

Denali to present clinical data on rare disease therapies at WORLDSymposium

https://ng.investing.com/news/company-news/denali-to-present-clinical-data-on-rare-disease-therapies-at-worldsymposium-93CH-2313710
Denali Therapeutics Inc. (NASDAQ:DNLI) will present clinical and preclinical data for its Enzyme Transport Vehicle (ETV) programs at the 22nd Annual WORLDSymposium. The presentations will include data on therapies for Hunter syndrome and Sanfilippo syndrome type A, with a regulatory decision for tividenofusp alfa expected by April 5, 2026. Analysts maintain a bullish outlook on Denali due to its financial flexibility and innovative pipeline, with the company's shares trading near their 52-week high.

Denali to present clinical data on rare disease therapies at WORLDSymposium

https://www.investing.com/news/company-news/denali-to-present-clinical-data-on-rare-disease-therapies-at-worldsymposium-93CH-4474398
Denali Therapeutics (NASDAQ:DNLI) will present clinical and preclinical data for its Enzyme Transport Vehicle (ETV) programs at the 22nd Annual WORLDSymposium. The presentations will include follow-up data for Hunter syndrome and preliminary data for Sanfilippo syndrome type A, alongside the design for a Pompe disease study. The company, which holds more cash than debt, also awaits a regulatory decision on tividenofusp alfa for Hunter syndrome by April 5, 2026, with analysts showing a bullish outlook despite expected unprofitability this year.
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Denali Therapeutics Announces Data Presentations on Enzyme TransportVehicle™ Programs for Hunter Syndrome, Sanfilippo Syndrome Type A and Pompe Disease at Upcoming 2026 WORLDSymposium™

https://www.manilatimes.net/2026/01/30/tmt-newswire/globenewswire/denali-therapeutics-announces-data-presentations-on-enzyme-transportvehicle-programs-for-hunter-syndrome-sanfilippo-syndrome-type-a-and-pompe-disease-at-upcoming-2026-worldsymposium/2268253
Denali Therapeutics (Nasdaq: DNLI) will present clinical and preclinical data on its Enzyme TransportVehicle™ (ETV) programs for Hunter syndrome, Sanfilippo syndrome type A, and Pompe disease at the 22nd Annual WORLD Symposium™ in February 2026. The presentations will highlight continued follow-up data for tividenofusp alfa (DNL310) for Hunter syndrome, preliminary data for DNL126 for Sanfilippo syndrome type A, and the Phase 1 study design for DNL952 for Pompe disease. The company also notes that the FDA is conducting a Priority Review for tividenofusp alfa, with a decision expected by April 5, 2026.

Denali Therapeutics Announces Data Presentations on Enzyme TransportVehicle™ Programs for Hunter Syndrome, Sanfilippo Syndrome Type A and Pompe Disease at Upcoming 2026 WORLDSymposium™

https://www.stocktitan.net/news/DNLI/denali-therapeutics-announces-data-presentations-on-enzyme-transport-xzkpbkfardp3.html
Denali Therapeutics will present clinical and preclinical data for its Enzyme TransportVehicle (ETV) programs for Hunter Syndrome, Sanfilippo Syndrome Type A, and Pompe disease at the 2026 WORLDSymposium in February. The presentations will include Phase 1/2 follow-up for tividenofusp alfa (DNL310), preliminary Phase 1/2 data for DNL126, and a Phase 1 study design for DNL952. The company also noted that the U.S. FDA is conducting a Priority Review of the Biologics License Application for tividenofusp alfa, with a decision expected by April 5, 2026.

Denali Therapeutics (DNLI) Gets a Buy from Bank of America Securities

https://www.theglobeandmail.com/investing/markets/stocks/DNLI/pressreleases/37272522/denali-therapeutics-dnli-gets-a-buy-from-bank-of-america-securities/
Bank of America Securities analyst Tazeen Ahmad maintained a Buy rating on Denali Therapeutics (DNLI) with a price target of $29.00. Despite a Strong Buy consensus among analysts with a target of $32.36, the company reported a GAAP net loss of $126.9 million in its latest quarter, and corporate insider sentiment is negative due to recent share sales.

REGENXBIO Delay Could Put Denali in Pole Position for Hunter Syndrome Approval

https://www.biospace.com/fda/regenxbio-delay-could-put-denali-in-pole-position-for-hunter-syndrome-approval
A tumor discovery in a patient treated with REGENXBIO's Hurler syndrome gene therapy, RGX-111, has led the FDA to place clinical holds on both its Hurler and Hunter syndrome programs. This development, occurring just before REGENXBIO's Hunter syndrome gene therapy (RGX-121) PDUFA date, could give Denali Therapeutics a significant advantage, potentially allowing its Hunter syndrome treatment, tividenofusp alfa, to be first to market. Denali's therapy is not gene-based and avoids the AAV vector issues that prompted REGENXBIO's hold.

Denali Therapeutics (NASDAQ:DNLI) Shares Up 11.3% - Here's Why

https://www.marketbeat.com/instant-alerts/denali-therapeutics-nasdaqdnli-shares-up-113-heres-why-2026-01-22/
Denali Therapeutics (NASDAQ:DNLI) shares surged 11.3% following a strong session with increased trading volume. Analysts maintain an overwhelmingly "Buy" consensus with an average price target of $32.77, though some insider selling by the CEO and another insider was noted. The company reported better-than-expected quarterly earnings, topping analyst estimates by $0.02, and institutional investors hold a significant portion of its stock.
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Liquidity Mapping Around (DNLI) Price Events

https://news.stocktradersdaily.com/news_release/149/Liquidity_Mapping_Around_DNLI_Price_Events_012226025001_1769068201.html
Stock Traders Daily provides an AI-driven analysis of Denali Therapeutics Inc. (NASDAQ: DNLI), identifying a neutral near-term sentiment but strong mid-term sentiment that may be stalling. The analysis details specific institutional trading strategies, including long, breakout, and short positions with defined entry points, targets, and stop losses. Key findings highlight a 57.2:1 risk-reward short setup and multi-timeframe signal analysis to guide trading decisions.

Denali Therapeutics Inc. (NASDAQ:DNLI) Given Average Rating of "Buy" by Brokerages

https://www.marketbeat.com/instant-alerts/denali-therapeutics-inc-nasdaqdnli-given-average-rating-of-buy-by-brokerages-2026-01-20/
Denali Therapeutics Inc. (NASDAQ:DNLI) has received an average "Buy" rating from sixteen brokerages, with a mean 12-month price target of $32.77. Despite recent insider stock sales by the CEO and another insider, accounting for 52,416 shares, institutional investors and hedge funds own a significant portion of the company. Denali remains a clinical-stage biopharmaceutical focusing on neurodegenerative diseases, currently unprofitable with a Q3 EPS of -$0.74, but analysts anticipate an EPS of -$2.71 for the current fiscal year.

Campbell & CO Investment Adviser LLC Purchases 74,066 Shares of Denali Therapeutics Inc. $DNLI

https://www.marketbeat.com/instant-alerts/filing-campbell-co-investment-adviser-llc-purchases-74066-shares-of-denali-therapeutics-inc-dnli-2026-01-16/
Campbell & CO Investment Adviser LLC significantly increased its stake in Denali Therapeutics Inc. (NASDAQ:DNLI) by 51.9% in the third quarter, now holding 216,774 shares valued at $3.15 million. This comes despite recent insider selling by the CEO and another insider, who collectively sold over 52,000 shares at $16.50 each. Analysts maintain a "Buy" consensus rating for DNLI, with a target price of $32.77, while the stock currently trades around $18.78.

Denali Therapeutics stock maintains Buy rating at Goldman Sachs on pipeline progress

https://www.investing.com/news/analyst-ratings/denali-therapeutics-stock-maintains-buy-rating-at-goldman-sachs-on-pipeline-progress-93CH-4448987
Goldman Sachs has reaffirmed its Buy rating and $35.00 price target for Denali Therapeutics, citing strong pipeline progress and the promising potential of its Transport Vehicle platform. The company anticipates several key milestones, including the potential launch of tividenofusp alfa for Hunter syndrome by April 2026 and upcoming Phase 1/2 data for other programs targeting Sanfilippo syndrome and frontotemporal dementia. Despite current unprofitability, Denali maintains a solid financial position with ample cash reserves to support its development initiatives.

Have Denali Therapeutics Insiders Been Selling Stock?

https://www.sahmcapital.com/news/content/have-denali-therapeutics-insiders-been-selling-stock-2026-01-11
Denali Therapeutics' Co-Founder, Ryan Watts, recently sold a substantial US$581k worth of stock, reducing his holding by 1.5%. While this is the largest insider sale in the past year, insiders have not purchased any shares during the same period. Despite the selling activity, insiders still own a significant 4.6% of the company, valued at approximately US$122 million.
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Have Denali Therapeutics Insiders Been Selling Stock?

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-dnli/denali-therapeutics/news/have-denali-therapeutics-insiders-been-selling-stock
Denali Therapeutics Inc. (NASDAQ:DNLI) co-founder Ryan Watts recently sold US$581k worth of stock, reducing his holding by 1.5%. While there have been no insider purchases in the last year, insider ownership remains significant at 4.6%, valued at US$122m. The article suggests caution despite the high insider ownership, noting that past insider sales occurred even when the stock price was lower.

Ryan Watts Sells 35,198 Shares of Denali Therapeutics (NASDAQ:DNLI) Stock

https://www.marketbeat.com/instant-alerts/ryan-watts-sells-35198-shares-of-denali-therapeutics-nasdaqdnli-stock-2026-01-08/
Denali Therapeutics CEO Ryan Watts sold 35,198 shares of company stock on January 6th, 2026, for a total of $580,767. This transaction reduced his holding by 10.60% to 296,833 shares. The company's stock is currently trading around $17.07, with analysts maintaining a consensus "Buy" rating and a target price of $32.77.

How Tividenofusp’s Brain-Penetrant MPS II Data And FDA Priority Review At Denali (DNLI) Has Changed Its Investment Story

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-dnli/denali-therapeutics/news/how-tividenofusps-brain-penetrant-mps-ii-data-and-fda-priori/amp
Denali Therapeutics (DNLI) has seen a shift in its investment narrative due to promising Phase 1/2 data for its tividenofusp alfa therapy for Hunter syndrome, published in The New England Journal of Medicine. The therapy's ability to cross the blood-brain barrier and its FDA Priority Review status with an accelerated approval decision expected by April 5, 2026, validate Denali's TransportVehicle platform and elevate the immediate importance of this product's outcome. Investors are now closely watching the FDA decision and the ongoing COMPASS Phase 2/3 study, which are crucial for the company's future amidst its historical losses and financing activities.

Denali Therapeutics stock rating initiated at Buy by UBS on Hunter syndrome drug potential

https://za.investing.com/news/analyst-ratings/denali-therapeutics-stock-rating-initiated-at-buy-by-ubs-on-hunter-syndrome-drug-potential-93CH-4050520
UBS has initiated coverage on Denali Therapeutics (NASDAQ:DNLI) with a Buy rating and a $25 price target, driven by the potential FDA approval of DNL310 for Hunter syndrome. The investment bank anticipates DNL310 could generate over $500-700 million in sales and unlock significant value for Denali’s blood-brain barrier technology. While the company demonstrates strong financial health and promising pipeline programs, investors should note its current cash burn and unprofitability projections for the current year.

Denali Therapeutics Unveils Portfolio Goals for 2026, Stock Up

https://www.tradingview.com/news/zacks:b07b07196094b:0-denali-therapeutics-unveils-portfolio-goals-for-2026-stock-up/
Denali Therapeutics has outlined its strategic goals for 2026, focusing on the potential FDA approval and commercial launch of tividenofusp alfa for Hunter syndrome, which is expected by April 5, 2026. The company also anticipates significant milestones for other pipeline candidates, including data readouts for treatments for Sanfilippo syndrome type A, frontotemporal dementia, and Parkinson’s disease, as well as advancing an Alzheimer's disease treatment and a Pompe disease study. These developments, along with a strong cash position, are poised to transform Denali into a commercial-stage biotech, despite a recent stock performance decline.
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Denali Therapeutics Inc Announces Key Milestones and Priorities for 2026

https://www.tradingview.com/news/tradingview:aefb5ebc46637:0-denali-therapeutics-inc-announces-key-milestones-and-priorities-for-2026/
Denali Therapeutics Inc. (DNLI) announced its key milestones for 2026, including the planned commercial launch of tividenofusp alfa for Hunter syndrome after FDA approval. The company also anticipates clinical data readouts for several programs, including Sanfilippo syndrome and Parkinson's disease, and plans to initiate first-in-human studies for Alzheimer's and Pompe disease therapies, further advancing its blood-brain barrier crossing technologies.

Denali Therapeutics Announces Key Anticipated Milestones and Priorities for 2026 Including Commercial Launch of Tividenofusp Alfa for Hunter Syndrome

https://www.manilatimes.net/2026/01/06/tmt-newswire/globenewswire/denali-therapeutics-announces-key-anticipated-milestones-and-priorities-for-2026-including-commercial-launch-of-tividenofusp-alfa-for-hunter-syndrome/2253661
Denali Therapeutics has unveiled its key anticipated milestones and priorities for 2026, highlighted by the expected commercial launch of tividenofusp alfa for Hunter syndrome, a significant validation of its TransportVehicle™ (TV) platform. The company also anticipates multiple clinical data readouts across its pipeline for Sanfilippo syndrome Type A, frontotemporal dementia, and Parkinson's disease, alongside initiating first-in-human clinical studies for Alzheimer’s and Pompe disease. Denali aims to strengthen its leadership in blood-brain barrier crossing therapeutics through advancements in enzyme, oligonucleotide, and antibody programs.

Hunter syndrome drug nears FDA decision as new brain therapies move ahead

https://www.stocktitan.net/news/DNLI/denali-therapeutics-announces-key-anticipated-milestones-and-xeqx00bs0dby.html
Denali Therapeutics (DNLI) is preparing for the commercial launch of tividenofusp alfa for Hunter syndrome, with a PDUFA target date of April 5, 2026. The company also announced several clinical milestones for 2026, including data readouts and new study initiations for various neurodegenerative diseases and lysosomal storage disorders. Denali reported a strong financial position with approximately $872.9 million in cash as of Q3 2025, supplemented by recent equity financing and a royalty funding agreement.

Denali Therapeutics announces $200M proposed offering of common stock and pre-funded warrants

http://www.msn.com/en-us/money/companies/denali-therapeutics-announces-200m-proposed-offering-of-common-stock-and-pre-funded-warrants/ar-AA1S27Rz?ocid=finance-verthp-feeds&apiversion=v2&domshim=1&noservercache=1&noservertelemetry=1&batchservertelemetry=1&renderwebcomponents=1&wcseo=1
Denali Therapeutics (NASDAQ: DNLI) announced a proposed offering of common stock and pre-funded warrants worth $200 million. This move could impact the company's stock value and dilute existing shareholder equity.

Assessing Denali Therapeutics (DNLI) Valuation After Positive Hunter Syndrome Trial Data And FDA Priority Review

https://www.sahmcapital.com/news/content/assessing-denali-therapeutics-dnli-valuation-after-positive-hunter-syndrome-trial-data-and-fda-priority-review-2026-01-05
Denali Therapeutics (DNLI) is being re-evaluated after positive Hunter Syndrome trial data and ongoing FDA Priority Review for its therapy, tividenofusp alfa. Despite recent clinical updates, the stock has experienced significant long-term declines, raising questions about whether current trading levels represent a buying opportunity or a value trap. While its Price-to-Book ratio is in line with the broader biotech industry, a Discounted Cash Flow model suggests the stock is trading at a notable discount to its estimated fair value.
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Assessing Denali Therapeutics (DNLI) Valuation After Positive Hunter Syndrome Trial Data And FDA Priority Review

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-dnli/denali-therapeutics/news/assessing-denali-therapeutics-dnli-valuation-after-positive/amp
Denali Therapeutics (DNLI) stock valuation is under scrutiny following positive Phase 1/2 data for its Hunter Syndrome therapy, tividenofusp alfa, and an ongoing FDA Priority Review for accelerated approval. Despite recent share price declines, the company trades at a Price to Book ratio of 2.7x, which is in line with the broader US biotechs industry average, and a Discounted Cash Flow model suggests an estimated fair value significantly higher than its current trading price. The article discusses whether this presents a buying opportunity or a value trap, considering the company's loss-making status and potential risks.

Denali Therapeutics stock holds Buy rating at Jefferies on FDA approval confidence

https://m.investing.com/news/analyst-ratings/denali-therapeutics-stock-holds-buy-rating-at-jefferies-on-fda-approval-confidence-93CH-4425602?ampMode=1
Jefferies has reiterated a Buy rating and $40.00 price target on Denali Therapeutics Inc. (NASDAQ:DNLI) due to strong confidence in FDA approval for its therapy by April 5, 2026. The company is actively progressing through regulatory reviews and clinical trials, with high liquidity to support its development. Recent promising Phase 1/2 trial results for Hunter syndrome and a $200 million public offering further highlight Denali's advancements and financial strategy.

Towards 2026, Focusing on Three High-Potential Biotechnology Companies

https://nai500.com/blog/2025/12/towards-2026-focusing-on-three-high-potential-biotechnology-companies/
The biotechnology industry experienced a strong recovery in 2025, driven by new drug approvals, R&D, and M&A activity. This article highlights three companies—Denali Therapeutics (DNLI), Nuvalent, Inc. (NUVL), and Vanda Pharmaceuticals (VNDA)—poised for significant growth in 2026 due to upcoming clinical readouts and regulatory catalysts. These companies are focused on neurodegenerative diseases, precision cancer therapies, and rare diseases/CNS disorders, respectively.

Denali Therapeutics Inc. (NASDAQ:DNLI) Given Consensus Rating of "Buy" by Brokerages

https://www.marketbeat.com/instant-alerts/denali-therapeutics-inc-nasdaqdnli-given-consensus-rating-of-buy-by-brokerages-2025-12-26/
Denali Therapeutics (NASDAQ:DNLI) has received a consensus "Buy" rating from brokerages, with an average 12-month price target of $32.58, significantly higher than its current share price of $17.20. Institutional investors, including Invesco and HSBC, have substantially increased their holdings in the company. Denali is a clinical-stage neurodegenerative biotech with lead programs targeting Parkinson's and Alzheimer's diseases, and recently reported an EPS of ($0.74), beating estimates.

Denali Therapeutics (DNLI): Revisiting Valuation After Secondary Offering and FDA Priority Review Voucher Progress

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-dnli/denali-therapeutics/news/denali-therapeutics-dnli-revisiting-valuation-after-secondar
Denali Therapeutics recently completed a $200 million secondary offering, strengthening its financial position as it pursues a potential FDA priority review voucher. The company currently trades at a price-to-book ratio of 2.9x, slightly above the US biotech industry average, suggesting investors are already factoring in some premium for its pipeline despite ongoing losses. The article raises questions about whether the current valuation reflects a mispriced pipeline or if the market has already fully discounted future growth, highlighting potential risks related to commercialization and FDA approvals.
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Does Denali’s $200M Equity Raise And FDA Talks Change The Bull Case For DNLI?

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-dnli/denali-therapeutics/news/does-denalis-200m-equity-raise-and-fda-talks-change-the-bull
Denali Therapeutics recently completed a US$200 million equity raise and is in ongoing discussions with the FDA regarding a potential priority review voucher. This fresh capital and regulatory dialogue could enhance their ability to advance their neurodegenerative drug pipeline, easing funding pressure and potentially accelerating future filings. However, clinical uncertainty and significant cash burn remain key risks for the company, with market participants closely watching the DNL310 FDA outcome.

Is Denali Therapeutics (DNLI) the Most Promising Mid-Cap Healthcare Stock Under $50?

https://www.insidermonkey.com/blog/is-denali-therapeutics-dnli-the-most-promising-mid-cap-healthcare-stock-under-50-1664185/
Denali Therapeutics (NASDAQ: DNLI) is highlighted as a promising mid-cap healthcare stock, with Wedbush analyst Laura Chico maintaining a Buy rating and a $30 target price after a recent $200 million secondary offering. All 11 analysts covering the stock have Buy calls, with a median 1-year price target of $31, implying significant upside. The company specializes in neurodegenerative diseases using its proprietary TransportVehicle™ platform.

15 Most Promising Mid-Cap Healthcare Stocks Under $50

https://www.insidermonkey.com/blog/15-most-promising-mid-cap-healthcare-stocks-under-50-1662181/11/
This article highlights Denali Therapeutics (NASDAQ:DNLI) as a promising mid-cap healthcare stock under $50, noting its biotechnology focus on neurodegenerative diseases. Wedbush analyst Laura Chico maintained a "Buy" rating with a $30 target price after a recent $200 million secondary offering. The stock has received "Buy" calls from all 11 analysts, with a median one-year price target of $31, implying significant upside.

Does Denali Therapeutics' (DNLI) Discounted Equity Raise Reveal a New Phase in Its Risk Strategy?

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-dnli/denali-therapeutics/news/does-denali-therapeutics-dnli-discounted-equity-raise-reveal/amp
Denali Therapeutics recently completed a US$200 million equity offering, issuing common shares and pre-funded warrants at a discount. This capital injection aims to strengthen its balance sheet ahead of potential drug launches and further trials, particularly for its Hunter syndrome treatment. However, the raise also introduces dilution and highlights the company's reliance on regulatory outcomes and execution for its investment narrative, given its history of losses and zero current revenue.

Assessing Denali Therapeutics (DNLI) Valuation After Its $200 Million Follow-On Equity Offering

https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-dnli/denali-therapeutics/news/assessing-denali-therapeutics-dnli-valuation-after-its-200-m/amp
Denali Therapeutics (DNLI) recently completed a $200 million follow-on equity offering, impacting investor perception of dilution and cash runway. Despite a strong 90-day share price return, the company's valuation at 2.8x price to book is slightly richer than the broader US biotech sector, suggesting a premium for its pipeline. While appearing expensive compared to the typical biotech, Denali seems relatively inexpensive when benchmarked against a narrower peer group focused on platform scale and late-stage assets.
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