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DNLI announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, tividenofusp alfa , for the treatment of individuals with Hunter syndrome .Denali’s wholly owned program, DNL310 or tividenofusp alfa, is an Enzyme Transport Vehicle-enabled iduronate-2-sulfatase  replacement therapy in development for MPS II .Shares of DNLI have lost 1.9% in the past six months compared with the industry’s 8.3% decline.The FDA's above-mentioned designation is intended to expedite the development and review of therapeutic drugs being evaluated for the treatment of serious or life-threatening conditions.Breakthrough Therapy Designation is generally granted to a drug when evidences suggest that the investigational drug may provide substantial improvement over available therapy on at least one clinically significant endpoint.Data from the open-label phase I/II study have shown promising results, with positive effects on evidence-based surrogate endp","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/dnlis-hunter-syndrome-drug-gets-162000194.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["LU0234570918.USD","DNLI","IE00BFXG1179.USD","BIIB","HALO","BK4533","BK4548","BK4139","BK4535","IE00B19Z9Z06.USD","BK4588","LU0320765992.SGD","LU0053671581.USD","SNY","BK4585","IE00B894F039.SGD","BK4532","BK4007","LU0889565916.HKD","IE00B19Z9P08.USD","LU0109394709.USD"],"gpt_icon":0},{"id":"2501771412","title":"Denali Gets FDA Breakthrough Therapy Designation for Hunter Syndrome Treatment","url":"https://stock-news.laohu8.com/highlight/detail?id=2501771412","media":"MT Newswires Live","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2501771412?lang=en_us&edition=fundamental","pubTime":"2025-01-08 23:51","pubTimestamp":1736351504,"startTime":"0","endTime":"0","summary":"Denali Therapeutics  said Wednesday the US Food and Drug Administration has given breakthrough therapy designation for tividenofusp alfa to treat people with Hunter syndrome, a rare genetic disease.The designation was created to quicken the development and review of candidate drugs to treat serious or life-threatening diseases, the company said.The label is in addition to fast track designation, orphan drug designation, and rare pediatric disease designation that were all previously given by the FDA for tividenofusp alfa to treat Hunter syndrome, Denali added.Denali said it plans to file a biologics license application for tividenofusp alfa early this year.The company's shares were rising 1.6% in recent trading.Price: 21.52, Change: +0.34, Percent Change: +1.61","market":"sg","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK4139","BK4535","DNLI","BK4548"],"gpt_icon":0},{"id":"2501727284","title":"BRIEF-Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted To Tividenofusp Alfa For The Treatment Of Hunter Syndrome (MPS II)","url":"https://stock-news.laohu8.com/highlight/detail?id=2501727284","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2501727284?lang=en_us&edition=fundamental","pubTime":"2025-01-08 21:53","pubTimestamp":1736344403,"startTime":"0","endTime":"0","summary":"BRIEF-Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted To Tividenofusp Alfa For The Treatment Of Hunter Syndrome Jan 8  - Denali Therapeutics Inc DNLI.O:DENALI THERAPEUTICS ANNOUNCES U.S. FDA BREAKTHROUGH THERAPY DESIGNATION GRANTED TO TIVIDENOFUSP ALFA FOR THE TREATMENT OF HUNTER SYNDROME DENALI THERAPEUTICS INC - EXPECTS TO SUBMIT BLA FOR TIVIDENOFUSP ALFA IN EARLY 2025Source text: nGNX1hSTYbFurther company coverage: DNLI.O ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250108:nTUA1K1QJY:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4535","BK4548","DNLI","BK4139"],"gpt_icon":0},{"id":"2501972161","title":"Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (Mps Ii)","url":"https://stock-news.laohu8.com/highlight/detail?id=2501972161","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2501972161?lang=en_us&edition=fundamental","pubTime":"2025-01-08 21:00","pubTimestamp":1736341204,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250108:nTUA1K1QJY:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4139","BK4535","BK4548","DNLI"],"gpt_icon":0},{"id":"2501721579","title":"Denali Therapeutics Inc - Expects to Submit Bla for Tividenofusp Alfa in Early 2025","url":"https://stock-news.laohu8.com/highlight/detail?id=2501721579","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2501721579?lang=en_us&edition=fundamental","pubTime":"2025-01-08 21:00","pubTimestamp":1736341204,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250108:nTUA1K1QJY:2","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["DNLI","BK4548","BK4535","BK4139"],"gpt_icon":0},{"id":"2501472179","title":"Denali Therapeutics Announces U.S. FDA Breakthrough Therapy Designation Granted to Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II)","url":"https://stock-news.laohu8.com/highlight/detail?id=2501472179","media":"GlobeNewswire","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2501472179?lang=en_us&edition=fundamental","pubTime":"2025-01-08 21:00","pubTimestamp":1736341200,"startTime":"0","endTime":"0","summary":"Denali expects to submit a Biologics License Application for tividenofusp alfa in early 2025 for regulatory review under the accelerated approval pathway. SOUTH SAN FRANCISCO, Calif., Jan. 08, 2025  -- Denali Therapeutics Inc. , today announced that the U.S. Food and Drug Administration  has granted Breakthrough Therapy Designation for tividenofusp alfa  for the treatment of individuals with Hunter syndrome . This designation is in addition to Fast Track Designation, Orphan Drug Designation, and Rare Pediatric Disease Designation, all previously granted by the FDA for tividenofusp alfa in Hunter syndrome. Denali expects to submit a Biologics License Application  for tividenofusp alfa in early 2025 for regulatory review under the accelerated approval pathway.Breakthrough Therapy Designation is intended to expedite the development and review of therapeutic candidates that are under investigation for the treatment of serious or life-threatening conditions. Breakthrough Therapy Designation","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/denali-therapeutics-announces-u-fda-130000083.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4535","LENZ","BK4139","DNLI","ETV","BK4548"],"gpt_icon":0},{"id":"2501721718","title":"Denali Therapeutics price target lowered to $32 from $35 at BTIG","url":"https://stock-news.laohu8.com/highlight/detail?id=2501721718","media":"TipRanks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2501721718?lang=en_us&edition=fundamental","pubTime":"2025-01-08 20:25","pubTimestamp":1736339139,"startTime":"0","endTime":"0","summary":"BTIG analyst Thomas Shrader lowered the firm’s price target on Denali Therapeutics  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. The firm adds that it was one of the last legacy programs at Denali as management has made it clear that the pipeline will be increasingly focused on the TV side of development.Discover outperforming stocks and invest smarter with Top Smart Score Stocks. Filter, analyze, and streamline your search for investment opportunities using Tipranks' Stock Screener. 3 Best Stocks to Buy Now, 1/7/2025, According to Top Analysts. Denali Therapeutics price target lowered to $87 from $90 at H.C. Wainwright. Dena","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/denali-therapeutics-price-target-lowered-122539522.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/denali-therapeutics-price-target-lowered-122539522.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["DNLI","LENZ"],"gpt_icon":0},{"id":"2501753389","title":"Denali's ALS Study Fails to Meet Primary and Secondary Endpoints","url":"https://stock-news.laohu8.com/highlight/detail?id=2501753389","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2501753389?lang=en_us&edition=fundamental","pubTime":"2025-01-08 03:14","pubTimestamp":1736277240,"startTime":"0","endTime":"0","summary":"Denali Therapeutics Inc. DNLI announced disappointing top-line results from an analysis of Regimen G of the phase II/III HEALEY ALS Platform Trial on pipeline candidate DNL343.The HEALEY platform trial is evaluating eIF2B agonist DNL343 in the treatment of amyotrophic lateral sclerosis .DNL343 is a novel small molecule ALS therapeutic candidate that targets eIF2B, a central regulator of the integrated stress response.Shares of DNLI have lost 6.5% in the past six months compared with the industry’s 6.4% decline.A total of 186 participants who were randomized to receive DNL343 treatment were compared to 139 participants randomized to receive placebo in this regimen  or shared from a concurrently enrolling regimen .ALS causes the progressive degeneration of motor neurons, resulting in muscle weakness and atrophy. The most prevalent adult-onset progressive motor neuron disease, ALS affects approximately 30,000 people in the United States and an estimated 500,000 people worldwide.DNL343 was","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/denalis-als-study-fails-meet-191400678.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4535","SNY","BK4588","BK4139","BK4533","IE00B894F039.SGD","DNLI","LU0320765992.SGD","IE00BFXG1179.USD","BK4007","BK4585","BK4532","IE00B19Z9P08.USD","BK4548","BK4505","BIIB","IE00B19Z9Z06.USD","LU0889565916.HKD","IMCR","LU0234570918.USD","LU0109394709.USD"],"gpt_icon":0},{"id":"2501733775","title":"Denali Therapeutics' Amyotrophic Lateral Sclerosis Misses Pivotal Trial, But Analyst Says It Was Expected","url":"https://stock-news.laohu8.com/highlight/detail?id=2501733775","media":"Benzinga","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2501733775?lang=en_us&edition=fundamental","pubTime":"2025-01-08 01:48","pubTimestamp":1736272112,"startTime":"0","endTime":"0","summary":"On Monday, Denali Therapeutics Inc. 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  and survival through week 24.Also Read: Denali Therapeutics Neurodegenerative Disease Platform Sparks Analyst Optimistic. Key secondary endpoints, measuring muscle strength and respiratory function, were also not statistically different between the active and placebo groups at week 24.Overall, DNL343 was found to be safe and well-tolerated. Further analyses are anticipated later in 2025, including neurofilament light  and other fluid biomarkers, data from pre-specified subgroups, and extended findings from the active treatment extension period.William Blair noted tha","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/denali-therapeutics-amyotrophic-lateral-sclerosis-174832467.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["DNLI","BK4516","USAW.SI","LU0912757837.SGD","PSQ","TSYW.SI","IE00BKVL7J92.USD","IE00B19Z9P08.USD","QLD","LU0098860793.USD","LU0320765646.SGD","LU0158827948.USD","TQQQ","LU0158827781.USD","BK4533","BIIB","LU0267386448.USD","LU2089284900.SGD","LU0109394709.USD","BK4588","LENZ","NVIW.SI","QID","IE00BZ1G4Q59.USD","LU2023251221.USD","LU1732799900.SGD","MNQmain","IE00B19Z9Z06.USD","LU1720051108.HKD","LU1074936037.SGD","LU0314104364.USD",".IXIC","NQmain","LU2089283258.USD","IONS","BK4504","BK4139","BK4127","LU2028103732.USD","LU1548497426.USD","LU1363072403.SGD","SQQQ","BK4535","LU1668664300.SGD","LU0889565916.HKD","LU0795875169.SGD","LU2347655156.SGD","BK4585","USJW.SI"],"gpt_icon":1},{"id":"2501788955","title":"Denali recent pullback a buying opportunity, says Jefferies","url":"https://stock-news.laohu8.com/highlight/detail?id=2501788955","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2501788955?lang=en_us&edition=fundamental","pubTime":"2025-01-07 22:45","pubTimestamp":1736261117,"startTime":"0","endTime":"0","summary":"After Denali Therapeutics (DNLI) reported DNL343 did not meet the primary or key secondary endpoints in the Phase 2/3 HEALEY trial in amyotrophic l...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/denali-recent-pullback-a-buying-opportunity-says-jefferies?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/denali-recent-pullback-a-buying-opportunity-says-jefferies?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["BK4139","BK4535","DNLI","BK4548"],"gpt_icon":0},{"id":"2501020986","title":"Baird Initiates Denali Therapeutics at Outperform With $31 Price Target","url":"https://stock-news.laohu8.com/highlight/detail?id=2501020986","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2501020986?lang=en_us&edition=fundamental","pubTime":"2025-01-07 21:17","pubTimestamp":1736255840,"startTime":"0","endTime":"0","summary":"Denali Therapeutics (DNLI) has an average rating of buy and mean price target of $40.79, according to analysts polled by FactSet.(MT Newswires covers equity, commodity and economic research from major","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["LENZ","DNLI"],"gpt_icon":0},{"id":"2501220582","title":"BUZZ-Denali Therapeutics falls after ALS drug fails in mid-to-late stage trial","url":"https://stock-news.laohu8.com/highlight/detail?id=2501220582","media":"Reuters","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2501220582?lang=en_us&edition=fundamental","pubTime":"2025-01-07 20:51","pubTimestamp":1736254274,"startTime":"0","endTime":"0","summary":"** Shares of drug developer Denali Therapeutics     fall 6.7% to $18.50 premarket    ** Co late on Monday said its experimental ALS drug failed to meet the main goal of a mid-to-late stage study   ** Amyotrophic lateral sclerosis  is a fatal neurodegenerative disease    ** Co said the drug, DNL343, did not demonstrate a change in disease severity over time and in survival compared to placebo    ** The drug also did not meet key secondary goals of statistically significant improvements in muscle strength and respiratory function   ** Brokerage H.C. Wainwright cuts PT to $87 from $90, says \"the results are not shocking given the complexities of conducting a perfect ALS trial\"    ** Up to last close, stock had fallen 5% in 2024  ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.rkd.refinitiv.com/api/News/News.svc/REST/News_1/RetrieveStoryML_1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LENZ","DNLI","BK4548","BK4139","BK4535"],"gpt_icon":0},{"id":"2501320825","title":"Denali Therapeutics Shares Down 8.3% Premarket After Co's ALS Drug Fails in Mid-to-Late Stage Trial","url":"https://stock-news.laohu8.com/highlight/detail?id=2501320825","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2501320825?lang=en_us&edition=fundamental","pubTime":"2025-01-07 20:27","pubTimestamp":1736252847,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250107:nL4N3O30YO:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4535","DNLI","BK4139","BK4548"],"gpt_icon":0}],"pageSize":16,"totalPage":6,"pageCount":3,"totalSize":94}]}}