| 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? |
zacks.com |
2025-05-07 18:10:42 |
Czytaj oryginał (ang.) |
| 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. |
globenewswire.com |
2025-05-06 20:01:00 |
Czytaj oryginał (ang.) |
| 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. |
zacks.com |
2025-05-05 14:15:41 |
Czytaj oryginał (ang.) |
| 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.com |
2025-04-03 14:35:55 |
Czytaj oryginał (ang.) |
| 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. |
globenewswire.com |
2025-04-02 12:00:00 |
Czytaj oryginał (ang.) |
| 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. |
seekingalpha.com |
2025-03-20 16:16:45 |
Czytaj oryginał (ang.) |
| 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.com |
2025-03-20 12:00:35 |
Czytaj oryginał (ang.) |
| 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.com |
2025-02-28 16:16:23 |
Czytaj oryginał (ang.) |
| 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. |
globenewswire.com |
2025-02-27 18:01:00 |
Czytaj oryginał (ang.) |
| 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.com |
2025-02-07 12:56:35 |
Czytaj oryginał (ang.) |
| Denali Therapeutics Announces Primary Analysis and Long-Term Follow-Up of Phase 1/2 Study in Hunter Syndrome (MPS II) with Tividenofusp Alfa |
SOUTH SAN FRANCISCO, Calif., Feb. 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), today announced the primary analysis of the Phase 1/2 study in 47 participants with Hunter syndrome (MPS II) in the 24-week treatment period and additional long-term follow-up of its investigational therapeutic tividenofusp alfa (DNL310). These data, along with recent Breakthrough Therapy designation, further support the company's plan to submit a biologics license application (BLA) in early 2025 for accelerated approval and deliver this potential treatment to the Hunter syndrome community in late 2025 or early 2026. The Phase 1/2 results are being presented this week at the 21st Annual WORLDSymposium™ conference in San Diego, California. |
globenewswire.com |
2025-02-06 13:42:00 |
Czytaj oryginał (ang.) |
| 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. |
zacks.com |
2025-01-21 09:16:09 |
Czytaj oryginał (ang.) |
| Why Is Denali Therapeutics Stock Trading Higher On Wednesday? |
Denali Therapeutics Inc DNLI CEO Ryan Watts presented at the J.P. Morgan Healthcare Conference. |
benzinga.com |
2025-01-15 16:26:47 |
Czytaj oryginał (ang.) |
| Denali: Despite ALS Primary Endpoint Failure, Possible Path Forward Remains |
Denali Therapeutics Inc.'s DNL343 failed to meet the primary endpoint in the phase 2/3 HEALY ALS trial, but potential biomarker analyses in 2025 may offer a path forward. Despite the trial setback in ALS, Denali's stock remains stable due to continued pre-specified analyses expected in late 2025. BLA filing of tividenofusp alfa for the treatment of patients with MPS II remains on track under the Accelerated Approval Pathway Program in early 2025. |
seekingalpha.com |
2025-01-09 17:56:43 |
Czytaj oryginał (ang.) |
| 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.com |
2025-01-09 14:30:53 |
Czytaj oryginał (ang.) |
| 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.com |
2025-01-07 17:16:14 |
Czytaj oryginał (ang.) |
| Denali Therapeutics ALS drug fails in mid-stage trial |
Denali Therapeutics said on Monday its experimental drug failed to meet the main goal of a mid-to-late stage trial in patients with amyotrophic lateral sclerosis (ALS), a fatal neurodegenerative disease. |
reuters.com |
2025-01-06 18:43:22 |
Czytaj oryginał (ang.) |
| Denali Therapeutics Announces Topline Results for Regimen G Evaluating eIF2B Agonist DNL343 in the Phase 2/3 HEALEY ALS Platform Trial |
SOUTH SAN FRANCISCO, Calif., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI) today announced topline results from an analysis of Regimen G of the Phase 2/3 HEALEY ALS Platform Trial evaluating eIF2B agonist DNL343 in the treatment of amyotrophic lateral sclerosis (ALS). |
globenewswire.com |
2025-01-06 18:30:00 |
Czytaj oryginał (ang.) |
| Denali Therapeutics Neurodegenerative Disease Platform Sparks Analyst Optimistic |
William Blair has initiated coverage on Denali Therapeutics Inc DNLI, a company focused on developing drugs for neurodegenerative diseases. |
benzinga.com |
2025-01-03 15:08:02 |
Czytaj oryginał (ang.) |
| 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? |
zacks.com |
2024-12-09 08:49:24 |
Czytaj oryginał (ang.) |
| 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.com |
2024-12-06 12:50:20 |
Czytaj oryginał (ang.) |
| Denali Has A Neurodegenerative Edge Despite Market Skepticism |
Denali Therapeutics' unique blood-brain barrier technology and strategic partnerships offer a significant edge in the challenging neurodegenerative disease landscape. The company's strong cash position and disciplined financial strategy support its ambitious R&D and commercialization efforts without immediate need for additional funding. Denali's pipeline targets critical neurodegenerative pathways, with promising candidates for lysosomal storage disorders, Parkinson's disease, and neuroinflammation. |
seekingalpha.com |
2024-11-16 10:56:46 |
Czytaj oryginał (ang.) |
| 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.com |
2024-11-08 13:10:35 |
Czytaj oryginał (ang.) |
| 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. |
globenewswire.com |
2024-11-06 18:01:00 |
Czytaj oryginał (ang.) |
| 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.com |
2024-10-29 13:06:53 |
Czytaj oryginał (ang.) |
| Strength Seen in Denali Therapeutics (DNLI): Can Its 10.1% Jump Turn into More Strength? |
Denali Therapeutics (DNLI) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock suggests that there could be more strength down the road. |
zacks.com |
2024-09-16 16:26:07 |
Czytaj oryginał (ang.) |
| Denali Plans to File for Accelerated Approval of Hunter Syndrome Drug |
DNLI's recent meeting with the FDA was successful and provides the path to file for accelerated approval of tividenofusp alfa for the treatment of MPS II and its subsequent conversion to full approval. |
zacks.com |
2024-09-04 16:41:18 |
Czytaj oryginał (ang.) |
| Denali Therapeutics Announces Successful Meeting with the FDA and Plans to File for Accelerated Approval of Tividenofusp Alfa (DNL310) for the Treatment of MPS II (Hunter Syndrome) |
SOUTH SAN FRANCISCO, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced the outcome of a recent successful meeting with the Center for Drug Evaluation and Research (CDER) division of the U.S. Food and Drug Administration (FDA) providing a path to filing a biologics license application (BLA) for accelerated approval and subsequent conversion to full approval for tividenofusp alfa (DNL310) for the treatment of MPS II (Hunter syndrome). Agreement was reached that cerebrospinal fluid heparan sulfate (CSF HS) is reasonably likely to predict clinical benefit and can be used as a surrogate endpoint to support accelerated approval for tividenofusp alfa in MPS II. Based on discussions with CDER, Denali will include preclinical and clinical data on biomarkers (CSF HS and neurofilament light (NfL)) and safety in the BLA for tividenofusp alfa as a treatment of MPS II and intends to submit the BLA under the accelerated approval pathway in early 2025. |
globenewswire.com |
2024-09-03 12:00:00 |
Czytaj oryginał (ang.) |
| Denali Therapeutics: A Promising Biotech With Revolutionary BBB-Crossing Technology |
Denali Therapeutics' proprietary Transport Vehicle technology enables drug delivery across the blood-brain barrier, targeting neurodegenerative diseases. DNL310, targeting MPS II, and DNL343 for ALS are key drug candidates with potential, though competition is significant. The company's $500 million capital raise supports its aggressive R&D investment, providing a runway for developing its pipeline. |
seekingalpha.com |
2024-08-20 02:55:59 |
Czytaj oryginał (ang.) |
| Denali Therapeutics Announces Publication in Science Translational Medicine Demonstrating the Potential of the Oligonucleotide Transport Vehicle Platform to Achieve Broad Biodistribution of Antisense Oligonucleotides in the CNS and Muscle Following Intravenous Administration |
SOUTH SAN FRANCISCO, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative and lysosomal storage diseases, today announced publication of nonclinical data in the August 14, 2024 issue of Science Translational Medicine (link) demonstrating the ability of the Oligonucleotide Transport Vehicle (OTV) platform to achieve broad biodistribution of antisense oligonucleotides (ASOs) in the central nervous system (CNS) and skeletal and cardiac muscle following intravenous (IV) administration. |
globenewswire.com |
2024-08-14 18:00:00 |
Czytaj oryginał (ang.) |
| Wall Street Analysts Believe Denali Therapeutics (DNLI) Could Rally 79.62%: Here's is How to Trade |
The consensus price target hints at a 79.6% upside potential for Denali Therapeutics (DNLI). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term. |
zacks.com |
2024-08-06 14:55:46 |
Czytaj oryginał (ang.) |
| Denali Therapeutics Reports Second Quarter 2024 Financial Results and Business Highlights |
SOUTH SAN FRANCISCO, Calif., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company 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, today reported financial results for the second quarter ended June 30, 2024, and provided business highlights. |
globenewswire.com |
2024-08-01 10:45:00 |
Czytaj oryginał (ang.) |
| Denali Therapeutics (DNLI) Stock Jumps 9.7%: Will It Continue to Soar? |
Denali Therapeutics (DNLI) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions could translate into further price increase in the near term. |
zacks.com |
2024-07-23 11:16:08 |
Czytaj oryginał (ang.) |
| 3 Longevity Stocks to Buy for Anti-Aging Breakthroughs |
The United States population is aging faster than ever, attracting interest in longevity stocks. By 2030, one in five Americans will be a senior citizen, up from one in twenty 100 years ago. |
investorplace.com |
2024-07-08 23:09:21 |
Czytaj oryginał (ang.) |
| Denali (DNLI) Outperforms Industry in 3 Months: Here's Why |
Denali (DNLI) gains 11.9% in three months on positive updates on its candidates. |
zacks.com |
2024-06-28 13:40:34 |
Czytaj oryginał (ang.) |
| Denali Therapeutics (DNLI) Moves 5.8% Higher: Will This Strength Last? |
Denali Therapeutics (DNLI) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term. |
zacks.com |
2024-06-24 14:10:17 |
Czytaj oryginał (ang.) |
| Why Is Denali Therapeutics (DNLI) Up 15.6% Since Last Earnings Report? |
Denali Therapeutics (DNLI) reported earnings 30 days ago. What's next for the stock? |
zacks.com |
2024-06-06 16:36:23 |
Czytaj oryginał (ang.) |
| Denali's (DNLI) Candidate Selected for FDA's START Pilot Program |
Denali's (DNLI) DNL126, an investigational enzyme replacement therapy, gets selected for the START Pilot Program, intended to accelerate the development of rare disease therapies. |
zacks.com |
2024-06-04 18:21:08 |
Czytaj oryginał (ang.) |