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Denali Therapeutics Inc.

15.68

+0.19001.23%

Post-market: 15.38-0.3000-1.91%19:45 EDT

Volume:1.15M

Turnover:17.95M

Market Cap:2.28B

PE:-6.10

High:15.82

Open:15.23

Low:15.01

Close:15.49

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Overview Company News Filings

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

BUZZ-Denali Therapeutics begins marketing application for genetic disorder drug, shares rise

Denali Therapeutics Files Application for Accelerated Approval of Hunter Syndrome Treatment; Shares Up

MT Newswires Live

Denali initiates BLA filing for accelerated approval of tividenofusp alfa

BRIEF-Denali Therapeutics Announces Initiation Of BLA Filing For Accelerated Approval Of Tividenofusp Alfa For Treatment Of Hunter Syndrome

Denali Therapeutics Announces Initiation of Bla Filing for Accelerated Approval of Tividenofusp Alfa for Treatment of Hunter Syndrome (Mps Ii) and Positive Ongoing Interactions With FDA on Dnl126 Through Start Program

THOMSON REUTERS

Denali Therapeutics : Expects to Complete Bla Submission in First Half of May 2025

THOMSON REUTERS

Denali Therapeutics Inc: Continues to Prepare for a Potential Commercial Launch in U.S. in Late 2025 or Early 2026

THOMSON REUTERS

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

Biotech stocks have been hit by 'DOGE' and other fears. Why they're a great value now.

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

Denali Therapeutics Coverage Assumed by Morgan Stanley at Overweight

Analysts Offer Insights on Healthcare Companies: Denali Therapeutics (DNLI), Disc Medicine (IRON) and PTC Therapeutics (PTCT)

BRIEF-Denali Therapeutics Inc To Discontinue Active Treatment Extension In Regimen G

Denali Therapeutics discontinues active treatment extension in eIF2B Regimen G

Denali Therapeutics Inc - to Discontinue Active Treatment Extension in Regimen G

THOMSON REUTERS

B. Riley Trims Price Target on Denali Therapeutics to $35 From $38, Keeps Buy Rating

MT Newswires Live

Stock Track | Denali Therapeutics Inc. (DNLI) Soars 5.33% in Pre-Market Trading on Positive Analyst Insights

Analysts Offer Insights on Healthcare Companies: Denali Therapeutics (DNLI), Ardent Health Partners, Inc. (ARDT) and Doximity (DOCS)

Stock Track | Denali Therapeutics Plummets 5.16% as Price Target Cut on Lowered Probability of Success

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The same has also been received by the Center for Drug Evaluation and Research of the FDA.DNLI reported ongoing collaborative and productive engagement with CDER, aligning with the same on the content of the BLA data package, including the use of CSF HS as a surrogate endpoint for accelerated approval and the path to full approval.Denali expects to complete its BLA submission by mid-May 2025 and is preparing for a potential U.S. commercial launch in late 2025 or early 2026. 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the submission of marketing application in the first half of May 2025** DNLI plans a potential U.S. commercial launch in late 2025 or early 2026** Stock has fallen 34.5% YTD","market":"nz","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:20250402:nL3N3QG11U:1","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":null,"symbols":["BK4535","BK4548","BK4139","DNLI"],"gpt_icon":0},{"id":"2524896497","title":"Denali Therapeutics Files Application for Accelerated Approval of Hunter Syndrome Treatment; Shares Up","url":"https://stock-news.laohu8.com/highlight/detail?id=2524896497","media":"MT Newswires 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2026","url":"https://stock-news.laohu8.com/highlight/detail?id=2524462056","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524462056?lang=en_us&edition=fundamental","pubTime":"2025-04-02 20:00","pubTimestamp":1743595250,"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:20250402:nFWN3QG0CX:3","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","BK4535","BK4548","BK4139"],"gpt_icon":0},{"id":"2524460993","title":"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","url":"https://stock-news.laohu8.com/highlight/detail?id=2524460993","media":"GlobeNewswire","labels":["corporation"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524460993?lang=en_us&edition=fundamental","pubTime":"2025-04-02 20:00","pubTimestamp":1743595200,"startTime":"0","endTime":"0","summary":"Rolling submission of BLA initiated for tividenofusp alfa; preparations ongoing for potential U.S. commercial launch in late 2025 or early 2026. Alignment through recent interactions with CDER on path to accelerated approval and conversion to full approval for tividenofusp alfa. Productive collaboration continues under START for an accelerated development and approval path for DNL126. About Hunter Syndrome Hunter syndrome  is a rare genetic disease that affects over 2,000 individuals worldwide, primarily males, and leads to physical, cognitive, and behavioral symptoms. Hunter syndrome is caused by mutations in the iduronate-2-sulfatase  gene, which leads to a deficiency of the IDS enzyme. Symptoms often begin emerging around age two and include physical complications, including organ dysfunction, joint stiffness, hearing loss and impaired growth, and neurocognitive symptoms with impaired development. The disease is characterized by a buildup of glycosaminoglycans  in lysosomes — the pa","market":"nz","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-initiation-bla-120000209.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"corporation","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["TV","BK4535","ETV","BK4548","DNLI","BK4139","BK4100","LENZ"],"gpt_icon":0},{"id":"2522371948","title":"Biotech stocks have been hit by 'DOGE' and other fears. Why they're a great value now.","url":"https://stock-news.laohu8.com/highlight/detail?id=2522371948","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2522371948?lang=en_us&edition=fundamental","pubTime":"2025-03-27 19:40","pubTimestamp":1743075600,"startTime":"0","endTime":"0","summary":"Investors' deep pessimism is actually bullish, and less regulatory constraint could fuel new drug approval and M&A. Potential personnel cutbacks at the U.S. Food and Drug Administration also seem troubling. But maybe not. The retirement buyout offers for government employees exclude FDA staff who review drug approvals. \"So far, the FDA cuts have been related to medical technology and not in crucial drug regulatory roles,\" Yee said. He added that several companies have recently told him they've noticed no notable changes or delays at the FDA.","market":"other","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://dowjonesnews.com/newdjn/logon.aspx?AL=N","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":null,"symbols":["LU0070302665.USD","LU1989771016.USD","FTC","LU1037948897.HKD","IE00BBT3K403.USD","LU1037948541.HKD","LU0306807586.USD","LU1162221912.USD","NPV","LU0965509101.SGD","US2Y.BOND","IE00B2B36J28.USD","GPCR","IE00BN8TJ469.HKD","SG9999002232.USD","BK4548","DNLI","SWTX","LU1023059063.AUD","US10Y.BOND","BK4588","LU0868494617.USD","LU1430594728.SGD","PFE","LU2089984988.USD","SG9999001176.SGD","SG9999001440.SGD","BK4535","BHVN","US7Y.BOND","IE0002141913.USD","INSM","LU1929549753.HKD","US12M.BOND","US30Y.BOND","LU2023250843.SGD","MRK","US5Y.BOND","SG9999014567.USD","US3Y.BOND","BK4534","US6M.BOND","LU1093756325.SGD","LU0289739699.SGD","LU2361044865.SGD","LU0861579265.USD","BK4139","BK4007","LU0320765992.SGD","LU1934455863.HKD"],"gpt_icon":1},{"id":"2520631454","title":"Why You Shouldn't Bet Against Denali (DNLI) Stock","url":"https://stock-news.laohu8.com/highlight/detail?id=2520631454","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2520631454?lang=en_us&edition=fundamental","pubTime":"2025-03-20 20:57","pubTimestamp":1742475420,"startTime":"0","endTime":"0","summary":"One stock that might be an intriguing choice for investors right now is Denali Therapeutics Inc. DNLI. This is because this security in the Medical - Biomedical and Genetics space is seeing solid earnings estimate revision activity, and is in great company from a Zacks Industry Rank perspective.This is important because, often times, a rising tide will lift all boats in an industry, as there can be broad trends taking place in a segment that are boosting securities across the board. This is arguably taking place in the Medical - Biomedical and Genetics space as it currently has a Zacks Industry Rank of 75 out of more than 250 industries, suggesting it is well-positioned from this perspective, especially when compared to other segments out there.Meanwhile, Denali is actually looking pretty good on its own too. The firm has seen solid earnings estimate revision activity over the past month, suggesting analysts are becoming a bit more bullish on the firm’s prospects in both the short and ","market":"nz","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/why-shouldnt-bet-against-denali-125700418.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":["BK4139","BK4535","DNLI","BK4548"],"gpt_icon":0},{"id":"2517545638","title":"Denali Therapeutics Coverage Assumed by Morgan Stanley at Overweight","url":"https://stock-news.laohu8.com/highlight/detail?id=2517545638","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2517545638?lang=en_us&edition=fundamental","pubTime":"2025-03-08 01:33","pubTimestamp":1741368780,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/DNLI/analyst-ratings \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  March 07, 2025 12:33 ET (17:33 GMT)","market":"other","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://dowjonesnews.com/newdjn/logon.aspx?AL=N","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":null,"symbols":["DNLI","LENZ"],"gpt_icon":0},{"id":"2517484516","title":"Analysts Offer Insights on Healthcare Companies: Denali Therapeutics (DNLI), Disc Medicine (IRON) and PTC Therapeutics (PTCT)","url":"https://stock-news.laohu8.com/highlight/detail?id=2517484516","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2517484516?lang=en_us&edition=fundamental","pubTime":"2025-03-07 20:12","pubTimestamp":1741349542,"startTime":"0","endTime":"0","summary":"There’s a lot to be optimistic about in the Healthcare sector as 3 analysts just weighed in on Denali Therapeutics (DNLI – Research Report), Disc M...","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/analysts-offer-insights-on-healthcare-companies-denali-therapeutics-dnli-disc-medicine-iron-and-ptc-therapeutics-ptct?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/blurbs/analysts-offer-insights-on-healthcare-companies-denali-therapeutics-dnli-disc-medicine-iron-and-ptc-therapeutics-ptct?utm_source=itigerup.com&utm_medium=referral","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":"tipranks_highlight","symbols":["LU0320765992.SGD","LU1721428347.USD","BK4554","LU2362541273.HKD","LU2362540622.SGD","LU2506952337.HKD","LU2506952410.USD","LU2477742899.HKD","LU2362541513.USD","BK4139","BK4585","BK4535","LU1951200564.SGD","BK4137","LU1951198990.SGD","PTCT","LU0889565916.HKD","BK4023","LU0109394709.USD","IRON","HCSG","DNLI","BK4548","PTC","LU1923623000.USD","BK4588","BK4576"],"gpt_icon":0},{"id":"2517434978","title":"BRIEF-Denali Therapeutics Inc To Discontinue Active Treatment Extension In Regimen G","url":"https://stock-news.laohu8.com/highlight/detail?id=2517434978","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2517434978?lang=en_us&edition=fundamental","pubTime":"2025-03-06 07:05","pubTimestamp":1741215919,"startTime":"0","endTime":"0","summary":"BRIEF-Denali Therapeutics Inc To Discontinue Active Treatment Extension In Regimen GMarch 5 (Reuters) - 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