Denali Therapeutics Inc. (4DN.F)

12.88

+1.51

+(13.24%)

As of 8:18:00 AM GMT+2. Market Open.

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.

Zacks 20 days ago

DNLI
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

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 announ

GlobeNewswire 21 days ago

DNLI
Why You Shouldn't Bet Against Denali (DNLI) Stock

Denali (DNLI) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.

Zacks last month

DNLI
Denali Therapeutics price target lowered to $42 from $50 at Oppenheimer

Oppenheimer analyst Jay Olson lowered the firm’s price target on Denali Therapeutics (DNLI) to $42 from $50 and keeps an Outperform rating on the shares following quarterly results and after hosting CEO Ryan Watts at the firm’s 35th Annual Healthcare Conference. Oppenheimer remains optimistic about the multiple opportunities ahead. Near term, it anticipates imminent filing for DNL310 in Hunter syndrome and suspect a high likelihood for priority review; additional regulatory and clinical updates

TipRanks last month

DNLI
Is Denali Therapeutics Inc. (DNLI) Among Jeff Bezos’ Investments in 2025?

We recently compiled a list of the Jeff Bezos Investments in 2025: 12 Companies Bezos Is Investing In. In this article, we are going to take a look at where Denali Therapeutics Inc. (NASDAQ:DNLI) stands against the other companies Bezos is investing in. Since leaving his position as CEO of Amazon in 2021, Jeff Bezos has […]

Insider Monkey last month

DNLI
Denali Q4 Earnings Beat Estimates, Hunter Syndrome Drug in Focus

DNLI reports a narrower-than-expected loss for the fourth quarter of 2024. Denali remains on track to submit a BLA for tividenofusp alfa for the treatment of MPS II (Hunter syndrome).

Zacks last month

DNLI
Denali Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights

SOUTH SAN FRANCISCO, Calif., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the fourth quarter and year ended December 31, 2024, and provided business highlights. “In 2024, we made significant strides across our portfolio, particularly with our Enzyme Transport Vehicle (ETV) programs, achieving a path to a potential accelerated approval for our lead program in MPS II,” said Ryan Watts, Ph.D., CEO of Denali. “In 2025, we will continu

GlobeNewswire last month

DNLI
DNLI Reports Upbeat Longer-Term Data From Hunter Syndrome Study

Denali announces encouraging additional longer-term data from the phase I/II Hunter Syndrome study of its investigational therapy, tividenofusp alfa.

Zacks 2 months ago

DNLI
Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) with Tividenofusp Alfa

Long-term data demonstrate that robust reductions and normalization in key biomarkers from baseline were maintained over time with continued improvement in hearing, cognition and adaptive behaviorLong-term safety data with median follow-up of two years, and out to more than four years, demonstrate that tividenofusp alfa was generally well tolerated Regulatory submission for accelerated approval is planned for early 2025; U.S. launch preparation is ongoing to deliver tividenofusp alfa to families

GlobeNewswire 2 months ago

DNLI
Denali Therapeutics Announces Upcoming Presentations on Hunter Syndrome (MPS II) and TransportVehicle™ Enabled Investigational Therapeutic Tividenofusp Alfa at the 2025 WORLDSymposium™

SOUTH SAN FRANCISCO, Calif., Jan. 30, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), today announced upcoming oral (platform) and poster presentations at the 21st Annual WORLDSymposium™, which will be held February 3-7, 2025, in San Diego, California. The oral presentation includes clinical results related to its Hunter syndrome (MPS II) investigational therapeutic, tividenofusp alfa (DNL310). Tividenofusp alfa is enabled by the Denali TransportVehicle™ platform, which is desi

GlobeNewswire 2 months ago

DNLI
Denali Gains 26.6% in a Year: How Should You Play the Stock?

DNLI has had a good run in the past year on positive pipeline updates. A potential approval of its Hunter Syndrome drug should be a boost. However, recent pipeline setbacks warrant caution.

Zacks 2 months ago

DNLI

SNY
Why Denali Therapeutics (DNLI) Is the Biotech Stock with Biggest Upside Potential

We recently published a list of the 12 Biotech Stocks with the Biggest Upside Potential. In this article, we are going to take a look at where Denali Therapeutics, Inc. (NASDAQ:DNLI) stands against other biotech stocks with the biggest upside potential. Improving Trends for Biotech Stocks While 2024 was a “challenging” year for biotech stocks, […]

Insider Monkey 3 months ago

DNLI
Denali Therapeutics Announces Key Anticipated 2025 Milestones and Priorities to Further Advance Its Therapeutics Portfolio for Neurodegeneration and Lysosomal Storage Diseases

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 therapeutic

GlobeNewswire 3 months ago

DNLI
DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy Designation

Denali obtains Breakthrough Therapy Designation for its experimental candidate, tividenofusp alfa (DNL310), for the treatment of pateints with Hunter syndrome.

Zacks 3 months ago

DNLI
Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)

Denali expects to submit a Biologics License Application for tividenofusp alfa in early 2025 for regulatory review under the accelerated approval pathwaySOUTH SAN FRANCISCO, Calif., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tividenofusp alfa (DNL310) for the treatment of individuals with Hunter syndrome (MPS II). This designation is in addition to Fas

GlobeNewswire 3 months ago

DNLI
Denali Therapeutics price target lowered to $32 from $35 at BTIG

BTIG analyst Thomas Shrader lowered the firm’s price target on Denali Therapeutics (DNLI) to $32 from $35 and keeps a Buy rating on the shares after the company announced topline data from the Phase 2/3 HEALEY trial which was testing an agonist of eIF2B for amyotrophic lateral sclerosis. The DNL343 failure is sobering as the program was backed by convincing pre-clinical data showing reduced aggregation of key drivers of ALS pathology such as TDP-43, the analyst tells investors in a research note

TipRanks 3 months ago

DNLI
Denali Reverses Its Fortunes With 'Too Early' Miss In ALS Treatment

Denali Therapeutics shares reversed higher on Tuesday after the drugmaker's ALS treatment failed in a six-month study.

Investor's Business Daily 3 months ago

DNLI
Denali's ALS Study Fails to Meet Primary and Secondary Endpoints

DNLI's DNL343 fails to achieve the primary and secondary endpoints, as observed from an analysis of Regimen G of the phase II/III HEALEY ALS platform trial.

Zacks 3 months ago

DNLI

SNY
Denali Therapeutics' Amyotrophic Lateral Sclerosis Misses Pivotal Trial, But Analyst Says It Was Expected

On Monday, Denali Therapeutics Inc. (NASDAQ:DNLI) revealed topline results from an analysis of Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating DNL343 for amyotrophic lateral sclerosis. Compared to placebo, the study did not meet the primary endpoint of efficacy in slowing disease progression. The primary endpoint was evaluated as a change in disease severity over time as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) and survival through week 24. Also Read: Denali

Benzinga 3 months ago

DNLI
Denali Therapeutics’ ALS therapy fails to meet primary endpoint in Phase II/III trial

The primary analysis included 186 subjects who received the therapy and 139 subjects who were given a placebo.

Clinical Trials Arena 3 months ago

DNLI

Performance Overview

Return	4DN.F	S&P 500 (^GSPC)
YTD	-34.33%	-8.19%
1-Year	-13.68%	+6.49%
3-Year	-48.58%	+26.41%

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Denali Therapeutics Inc. (4DN.F)

DNLI Begins Rolling BLA Submission for Hunter Syndrome Drug, Stock Up

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

Why You Shouldn't Bet Against Denali (DNLI) Stock

Denali Therapeutics price target lowered to $42 from $50 at Oppenheimer

Is Denali Therapeutics Inc. (DNLI) Among Jeff Bezos’ Investments in 2025?

Denali Q4 Earnings Beat Estimates, Hunter Syndrome Drug in Focus

Denali Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights

DNLI Reports Upbeat Longer-Term Data From Hunter Syndrome Study

Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) with Tividenofusp Alfa

Denali Therapeutics Announces Upcoming Presentations on Hunter Syndrome (MPS II) and TransportVehicle™ Enabled Investigational Therapeutic Tividenofusp Alfa at the 2025 WORLDSymposium™

Denali Gains 26.6% in a Year: How Should You Play the Stock?

Why Denali Therapeutics (DNLI) Is the Biotech Stock with Biggest Upside Potential

Denali Therapeutics Announces Key Anticipated 2025 Milestones and Priorities to Further Advance Its Therapeutics Portfolio for Neurodegeneration and Lysosomal Storage Diseases

DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy Designation

Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)

Denali Therapeutics price target lowered to $32 from $35 at BTIG

Denali Reverses Its Fortunes With 'Too Early' Miss In ALS Treatment

Denali's ALS Study Fails to Meet Primary and Secondary Endpoints

Denali Therapeutics' Amyotrophic Lateral Sclerosis Misses Pivotal Trial, But Analyst Says It Was Expected

Denali Therapeutics’ ALS therapy fails to meet primary endpoint in Phase II/III trial

Performance Overview