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Denali Therapeutics Inc. (DNLI)

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19.10

-2.15

(-10.12%)

At close: January 10 at 4:00:02 PM EST

19.10

+0.00

+(0.00%)

After hours: January 10 at 5:41:12 PM EST

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 yesterday

DNLI
-10.12%
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 days ago

DNLI
-10.12%
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 days ago

DNLI
-10.12%
These Stocks Moved the Most Today: Nvidia, Micron, Aurora Innovation, Tesla, Carvana, Moderna, Palantir, and More

Nvidia falls after the company provides few updates about its artificial-intelligence chips at the CES trade show, while shares of Micron and Aurora Innovation jump after securing partnerships with the semiconductor giant.

Barrons.com 3 days ago

NVDA

MU

UBER
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 days ago

DNLI
-10.12%
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 days ago

DNLI
-10.12%
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 days ago

DNLI
-10.12%
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 days ago

DNLI
-10.12%
Denali Therapeutics Announces Topline Results for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform Trial

Primary endpoint of overall function (ALSFRS-R) and survival, and key secondary endpoints of muscle strength and respiratory function, were not met at 24 weeksOverall, DNL343 was found to be safe and well toleratedAdditional analyses, including neurofilament light (NfL) and other fluid biomarkers, prespecified sub-group analyses and analyses from the active treatment extension period are expected later in 2025 SOUTH SAN FRANCISCO, Calif., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc

GlobeNewswire 4 days ago

DNLI
-10.12%
Denali Therapeutics Neurodegenerative Disease Platform Sparks Analyst Optimistic

William Blair has initiated coverage on Denali Therapeutics Inc (NASDAQ:DNLI), a company focused on developing drugs for neurodegenerative diseases. The analyst highlights that Denali is developing a specialized transport vehicle (TV) platform to enhance the delivery of treatments across the blood-brain barrier. It stands out from competitors with its promising potential for top-tier performance and scalability across different therapies and conditions. The company’s lead program Tividenofusp al

Benzinga 7 days ago

DNLI
-10.12%
Denali Therapeutics upgraded to Buy from Hold at Stifel

Stifel upgraded Denali Therapeutics (DNLI) to Buy from Hold with a $37 price target Denali recently aligned with the FDA to file for accelerated approval for their lead candidate DLN310/tividenofusp alfa in MPS IIA/Hunter syndrome with a BLA submission expected early-2025, which “represents a major win,” the analyst tells investors. Though the firm thinks DNL310 should get approved, there are “still a number of outstanding questions,” the analyst added. Published first on TheFly – the ultimate s

TipRanks 25 days ago

DNLI
-10.12%
Why Is Denali Therapeutics (DNLI) Down 21.2% Since Last Earnings Report?

Denali Therapeutics (DNLI) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.

Zacks last month

DNLI
-10.12%
SNY

AGIO
Denali Starts Dosing in Phase II Parkinson's Disease Study

DNLI begins dosing in the phase IIa study on BIIB122 in approximately 50 participants with Parkinson's disease and LRRK2 pathogenic mutations confirmed by genetic testing.

Zacks last month

DNLI
-10.12%
SNY
Denali Therapeutics Announces First Participant Dosed in Phase 2a Study of LRRK2 Inhibitor, BIIB122, in LRRK2-Associated Parkinson’s Disease

SOUTH SAN FRANCISCO, Calif., Dec. 05, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced initiation of dosing in a global Phase 2a clinical study, BEACON, of the investigational drug leucine-rich repeat kinase 2 (LRRK2) inhibitor BIIB122 (DNL151) in participants with LRRK2-associated Parkinson’s disease (LRRK2-PD). LRRK2 inhibition is a potential therapeutic approach that may slow progression of Parkinson’s disease by targeting underlying lysosomal dysfunction impli

GlobeNewswire last month

DNLI
-10.12%
We're Hopeful That Denali Therapeutics (NASDAQ:DNLI) Will Use Its Cash Wisely

Just because a business does not make any money, does not mean that the stock will go down. For example, although...

Simply Wall St. last month

DNLI
-10.12%
Denali Q3 Earnings Miss Estimates, Pipeline Progress Encouraging

DNLI reports a wider-than-expected loss in the third quarter of 2024. Nonetheless, the pipeline progress has been encouraging.

Zacks 2 months ago

DNLI
-10.12%
SNY
Denali Therapeutics Reports Third Quarter 2024 Financial Results and Business Highlights

SOUTH SAN FRANCISCO, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the third quarter ended September 30, 2024, and provided business highlights. "As leaders in pioneering a new class of therapeutics that cross the blood-brain barrier, we are making significant progress across our Transport Vehicle (TV)-enabled portfolio,” said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. “Within our Enzyme TV (ETV) fra

GlobeNewswire 2 months ago

DNLI
-10.12%
Analysts Estimate Arcus Biosciences, Inc. (RCUS) to Report a Decline in Earnings: What to Look Out for

Arcus Biosciences (RCUS) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Zacks 2 months ago

RCUS
-4.83%
DNLI
-10.12%
Denali Therapeutics Inc. (DNLI) May Report Negative Earnings: Know the Trend Ahead of Q3 Release

Denali Therapeutics (DNLI) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Zacks 2 months ago

DNLI
-10.12%
Denali Therapeutics Inc. (DNLI): Jeff Bezos Is Buying This Stock Now

We recently compiled a list of the 8 Stocks Jeff Bezos is Buying. In this article, we are going to take a look at where Denali Therapeutics Inc. (NASDAQ:DNLI) stands against the other stocks Jeff Bezos is buying. ‘We are Famously Unprofitable’ Jeff Bezos is a name closely tied to Amazon the company he reportedly founded […]

Insider Monkey 2 months ago

DNLI
-10.12%

Performance Overview

Return	DNLI	S&P 500
YTD	-5.63%	-1.35%
1-Year	-3.24%	+22.51%
3-Year	-54.04%	+24.59%

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Denali Therapeutics Inc. (DNLI)

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

These Stocks Moved the Most Today: Nvidia, Micron, Aurora Innovation, Tesla, Carvana, Moderna, Palantir, and More

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

Denali Therapeutics Announces Topline Results for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform Trial

Denali Therapeutics Neurodegenerative Disease Platform Sparks Analyst Optimistic

Denali Therapeutics upgraded to Buy from Hold at Stifel

Why Is Denali Therapeutics (DNLI) Down 21.2% Since Last Earnings Report?

Denali Starts Dosing in Phase II Parkinson's Disease Study

Denali Therapeutics Announces First Participant Dosed in Phase 2a Study of LRRK2 Inhibitor, BIIB122, in LRRK2-Associated Parkinson’s Disease

We're Hopeful That Denali Therapeutics (NASDAQ:DNLI) Will Use Its Cash Wisely

Denali Q3 Earnings Miss Estimates, Pipeline Progress Encouraging

Denali Therapeutics Reports Third Quarter 2024 Financial Results and Business Highlights

Analysts Estimate Arcus Biosciences, Inc. (RCUS) to Report a Decline in Earnings: What to Look Out for

Denali Therapeutics Inc. (DNLI) May Report Negative Earnings: Know the Trend Ahead of Q3 Release

Denali Therapeutics Inc. (DNLI): Jeff Bezos Is Buying This Stock Now

Performance Overview