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Denali Therapeutics Inc.

14.09

+0.10000.71%

Volume:559.18K

Turnover:7.96M

Market Cap:2.05B

PE:-5.27

High:14.50

Open:14.49

Low:13.95

Close:13.99

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Overview Company News Filings

Oppenheimer Remains a Buy on Denali Therapeutics (DNLI)

Denali Therapeutics Inc. Files Initial Statement of Beneficial Ownership for Director Julian Baker

Denali Therapeutics Inc. Conducted Annual Stockholders Meeting

Denali Therapeutics Is Maintained at Outperform by Baird

Deutsche Bank Adjusts Denali Therapeutics Price Target to $28 From $29, Maintains Buy Rating

MT Newswires Live

Denali Therapeutics, Inc. : H.c. Wainwright Cuts Target Price to $32 From $80

THOMSON REUTERS

William Blair Keeps Their Buy Rating on Denali Therapeutics (DNLI)

Denali Therapeutics Inc reports results for the quarter ended March 31 - Earnings Summary

BRIEF-Denali Therapeutics Q1 Operating Expenses USD 145.58 Million

Denali Therapeutics Q1 Operating Income USD -145.58 Million

THOMSON REUTERS

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

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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. Tividenofusp alfa, an Enzyme Transport Vehicle-enabled iduronate-2-sulfatase  replacement therapy, enjoys the FDA’s Fast Track and Breakthrough Therapy designations in the United States for MPS II.In the EU, the candidate enjoys the Priority Medicines designation for ","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/dnli-begins-rolling-bla-submission-133200898.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["LU1559883803.SGD","BK4007","DNLI","LU0566484027.USD","BAYRY","DVAX","BK4532","BK4535","BK4548","BK4139"],"gpt_icon":1},{"id":"2524895415","title":"BUZZ-Denali Therapeutics begins marketing application for genetic disorder drug, shares rise","url":"https://stock-news.laohu8.com/highlight/detail?id=2524895415","media":"Reuters","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524895415?lang=en_us&edition=fundamental","pubTime":"2025-04-02 23:48","pubTimestamp":1743608880,"startTime":"0","endTime":"0","summary":"BUZZ-Denali Therapeutics begins marketing application for genetic disorder drug, shares rise        ** California-based drug developer Denali Therapeutics DNLI.O rise 11.4% to $13.70** DNLI says it has started the rolling submission of a marketing application for accelerated FDA approval of its experimental drug, tividenofusp alfa, to treat a type of rare genetic disorder called Hunter syndrome** Co says the drug is currently enrolling patients for a late-stage study** Hunter syndrome is where the body lacks an enzyme needed to break down certain sugars, causing these sugars to build up in the body, leading to various health problems     ** Co expects to complete 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":["DNLI","BK4548","BK4139","BK4535"],"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 Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524896497?lang=en_us&edition=fundamental","pubTime":"2025-04-02 22:36","pubTimestamp":1743604562,"startTime":"0","endTime":"0","summary":"Denali Therapeutics  said Wednesday it has submitted a biologics license application to the Center for Drug Evaluation and Research of the US Food and Drug Administration for accelerated approval of its Hunter syndrome investigational therapeutic, tividenofusp alfa.Denali said it expects to complete the rolling submission in the first half of May, with a potential commercial launch in the US in late 2025 or early 2026.Shares were up 6.6% in recent trading.Price: 13.10, Change: +0.81, Percent Change: 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