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Biogen

118.52

+2.031.74%

Volume:637.30K

Turnover:75.46M

Market Cap:17.35B

PE:10.60

High:119.72

Open:118.12

Low:117.40

Close:116.49

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Overview Company News Filings

Biogen Initiates Phase 3 Study of Felzartamab for the Treatment of Late Antibody-Mediated Rejection (AMR) in Kidney Transplant Patients

BUZZ - Nasdaq top and bottom performing stocks at about 11:01 a.m. EDT on 2025-03-10

Unusually active option classes on open March 10th

BUZZ- Some defensives outperform, even as indexes switch to gains

BUZZ - Nasdaq top and bottom performing stocks at about 11:01 a.m. EST on 2025-03-07

SLDB Stock Rallies 60% in a Month: Here's What You Should Know

Biogen Inc. Stock Outperforms Competitors On Strong Trading Day

Biogen (BIIB) Receives a Hold from Bernstein

Do You Own 15 Stocks Morningstar Calls The Top 'Wealth Destroyers?'

Biogen's Alzheimer's Treatment Lecanemab Denied Approval in Australia

MT Newswires Live

3 Reasons BIIB is Risky and 1 Stock to Buy Instead

As baby boomers turn 80, there aren't enough doctors to treat 'emergency levels' of dementia patients

Pfizer quietly made some big DEI changes

Biogen, Eisai: CHMP Reaffirms Backing of Leqembi Alzheimer's Drug

Biogen, Eisai Say EMA Panel Reaffirms Positive Opinion on Lecanemab

MT Newswires Live

The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease

Biogen, Eisai announces CHMP of EMA reaffirmed positive opinion of lecanemab

EU regulator reiterates positive recommendation for Eisai-Biogen's Alzheimer's drug

EU regulator not updating opinion on Eisai-Biogen's Alzheimer's drug

BRIEF-EMA's CHMP Says Opinion Recommending Marketing Authorisation For Leqembi Not Need To Be Updated

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The stock price increase was mainly due to positive initial data, announced in mid-Feb, fromthe early to mid-stage study of its next-generation gene therapy product candidate, SGT-003, for treating Duchenne muscular dystrophy .Interim biopsy data reported in the first three participants at day 90 showed an average microdystrophin expression of 110%, as measured by western blot, along with improvements in multiple biomarkers that are indicators of muscle health and resilience.In the past three months, shares of Solid Biosciences have gained 7.6% against the industry’s 1% decline.The initial data readout also showed encouraging early signals of potential cardiac benefit. SGT-003was well-tolerated in the first six DMD patients dosed. Adverse events were mostly mild to moderate in severity and consistent with those typically observed in AAV gene therapy.Currently,Sarepta TherapeuticsSRPT markets Elevidys as the only app","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/sldb-stock-rallies-60-month-141300442.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":["IE00BJJMRZ35.SGD","RHHBY","IE0002141913.USD","LU0889565916.HKD","IE00B2B36J28.USD","IE00B894F039.SGD","BK4539","BK4007","BK4585","03165","LU0320765992.SGD","BK4588","IE0009355771.USD","BK4130","BK4139","BK4532","BK4535","LU0234570918.USD","BK4533","IE00BJT1NW94.SGD","IE00B19Z9P08.USD","SRPT","LU0109394709.USD","IE00B19Z9Z06.USD","SLDB","BIIB","FA","IE00BFTCPJ56.SGD"],"gpt_icon":0},{"id":"2517119304","title":"Biogen Inc. Stock Outperforms Competitors On Strong Trading Day","url":"https://stock-news.laohu8.com/highlight/detail?id=2517119304","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2517119304?lang=en_us&edition=fundamental","pubTime":"2025-03-07 06:06","pubTimestamp":1741298760,"startTime":"0","endTime":"0","summary":"This article was automatically generated by MarketWatch using technology from Automated Insights.Shares of Biogen Inc.  rallied 2.50% to $147.37 Thursday, on what proved to be an all-around dismal trading session for the stock market, with the S&P 500 Index  falling 1.78% to 5,738.52 and Dow Jones Industrial Average  falling 0.99% to 42,579.08.This was the stock's fifth consecutive day of gains.Biogen Inc. closed 38.08% below its 52-week high of $238.00, which the company reached on July 12th.The stock outperformed some of its competitors Thursday, as Johnson & Johnson  rose 0.43% to $165.83, Pfizer Inc.  rose 1.16% to $26.24, and AbbVie Inc.  fell 0.37% to $210.75.Trading volume  remained 389,598 below its 50-day average volume of 1.5 M.Data source: Dow Jones Market Data, FactSet. Data compiled March 6, 2025.This content was created by MarketWatch, which is operated by Dow Jones & Co. MarketWatch is published independently from Dow Jones Newswires and The Wall Street Journal.","market":"sh","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":["BIIB"],"gpt_icon":0},{"id":"2517186251","title":"Biogen (BIIB) Receives a Hold from Bernstein","url":"https://stock-news.laohu8.com/highlight/detail?id=2517186251","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2517186251?lang=en_us&edition=fundamental","pubTime":"2025-03-06 14:56","pubTimestamp":1741244182,"startTime":"0","endTime":"0","summary":"In a report released yesterday, William Pickering from Bernstein maintained a Hold rating on Biogen (BIIB – Research Report), with a price target o...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/biogen-biib-receives-a-hold-from-bernstein?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/biogen-biib-receives-a-hold-from-bernstein?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":["LU0109394709.USD","LU0889565916.HKD","BIIB","IE00B19Z9P08.USD","BK4533","BK4585","IE00B894F039.SGD","BK4588","BK4532","BK4139","LU0320765992.SGD","IE00B19Z9Z06.USD","LU0234570918.USD"],"gpt_icon":0},{"id":"2516635557","title":"Do You Own 15 Stocks Morningstar Calls The Top 'Wealth Destroyers?'","url":"https://stock-news.laohu8.com/highlight/detail?id=2516635557","media":"Blockhead","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2516635557?lang=en_us&edition=fundamental","pubTime":"2025-03-03 21:00","pubTimestamp":1741006856,"startTime":"0","endTime":"0","summary":"The S&P 500 can generate massive wealth. But stocks can decimate portfolio values, too.","market":"us","thumbnail":"https://www.investors.com/wp-content/uploads/2023/08/Stock-moneydisappearing-01-adobe-150x150.jpg","type":0,"news_type":0,"thumbnails":["https://www.investors.com/wp-content/uploads/2023/08/Stock-moneydisappearing-01-adobe-150x150.jpg"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.investors.com/etfs-and-funds/sectors/sp500-you-own-15-stocks-morningstar-calls-the-top-wealth-destroyers/","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":"investor_business_daily_highlight","symbols":["LU0081259029.USD","BK4543","BK4128","BK4141","BK4515","BIIB","IE00B19Z9Z06.USD","LU0234570918.USD","BK4527","BK4139","BK4535","LU0321505868.SGD","LU0321505439.SGD","BK4554","LU0109394709.USD","BK4550","BK4112","IE00B19Z9P08.USD","MORN","INTC","BK4605","WBA","BK4585","BK4532","LU0889565916.HKD","BK4534","BK4512","BK4529","BK4602","BK4579","IE00B894F039.SGD","LU0320765992.SGD","LU1878469433.USD","BK4533","WBA.AU","BK4575","BK4588","LU2065731478.USD"],"gpt_icon":1},{"id":"2516680190","title":"Biogen's Alzheimer's Treatment Lecanemab Denied Approval in Australia","url":"https://stock-news.laohu8.com/highlight/detail?id=2516680190","media":"MT Newswires Live","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2516680190?lang=en_us&edition=fundamental","pubTime":"2025-03-03 20:20","pubTimestamp":1741004444,"startTime":"0","endTime":"0","summary":"Biogen  said Monday the Therapeutic Goods Administration of Australia has reaffirmed its earlier decision to reject lecanemab as a treatment for early Alzheimer's disease.The TGA suggested restricting the drug's use to ApoE4 noncarriers due to safety risks, but Biogen's revised proposals were declined as well, the company said.Biogen said the ruling excludes nearly 70% of potential patients and differs from approvals granted in 11 other countries, including the US and Japan.The company said it is evaluating its next steps, including a possible appeal to the administrative review tribunal, to make the treatment available in Australia.","market":"hk","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":["XJO.AU","BK4139","LU0234570918.USD","BK4533","BIIB","BK4532","BK4588","IE00B19Z9Z06.USD","XAO.AU","LU0320765992.SGD","BK4585","IE00B19Z9P08.USD","LU0109394709.USD","IE00B894F039.SGD","LU0889565916.HKD","XKO.AU"],"gpt_icon":0},{"id":"2516681415","title":"3 Reasons BIIB is Risky and 1 Stock to Buy Instead","url":"https://stock-news.laohu8.com/highlight/detail?id=2516681415","media":"StockStory","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2516681415?lang=en_us&edition=fundamental","pubTime":"2025-03-03 17:02","pubTimestamp":1740992555,"startTime":"0","endTime":"0","summary":"Shareholders of Biogen would probably like to forget the past six months even happened. The stock dropped 31.4% and now trades at $140.49. This was partly driven by its softer quarterly results and might have investors contemplating their next move.Is now the time to buy Biogen, or should you be careful about including it in your portfolio?Get the full stock story straight from our expert analysts, it’s free.Even with the cheaper entry price, we're cautious about Biogen. Here are three reasons why BIIB doesn't excite us and a stock we'd rather own.Founded in 1978 in Switzerland as one of the first biotech companies, Biogen today  discovers, develops, and sells therapies for neurological and neurodegenerative diseases like multiple sclerosis  and Alzheimer’s disease.Sadly for Biogen, its EPS declined by more than its revenue over the last five years, dropping 13.3% annually. This tells us the company struggled because its fixed cost base made it difficult to adjust to shrinking demand.G","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/3-reasons-biib-risky-1-090235816.html","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":"yahoofinance","symbols":["IE00BZ1G4Q59.USD","LU1732800096.USD","LU1162221912.USD","LU1363072403.SGD","LU1668664300.SGD","BK4516","LU1732799900.SGD","LU0106831901.USD","BK4139","LU0098860793.USD","LU2111349929.HKD","LU0320765992.SGD","BK4581","BK4127","LU1548497426.USD","LU2133065610.SGD","LU1720051108.HKD","LU0912757837.SGD","LU0234570918.USD","LU2347655156.SGD","LU0320765646.SGD","IE00B894F039.SGD","IE00B19Z9Z06.USD","LU1989772923.USD","LU1989772840.SGD","LU0158827948.USD","LU2089284900.SGD","BK4585","LU0267386448.USD","LU0889565916.HKD","LU1074936037.SGD","BIIB","IE00B19Z9P08.USD","LU0314104364.USD","LU0158827781.USD","LU0225283273.USD","BK4504","LU0106261372.USD","IE00BKVL7J92.USD","LU1720051017.SGD","BK4588","BK4534","LU0971096721.USD","BK4532","LU2357305700.SGD","BK4533","LU2271345857.HKD","LU2028103732.USD","LU2089283258.USD"],"gpt_icon":0},{"id":"2516598405","title":"As baby boomers turn 80, there aren't enough doctors to treat 'emergency levels' of dementia patients","url":"https://stock-news.laohu8.com/highlight/detail?id=2516598405","media":"Dow Jones","labels":["merge"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2516598405?lang=en_us&edition=fundamental","pubTime":"2025-03-01 21:25","pubTimestamp":1740835500,"startTime":"0","endTime":"0","summary":"'Dementia neurology deserts' already exist in 20 states. The future looks even more bleak.As the oldest baby boomers turn 80 this year, the medical industry is already overtaxed in its ability to provide dementia care - let alone handle the expected barrage of cases in the future.\"It's a dire situation. It's already at emergency levels - to get a diagnosis, to get care, and all the points along the way,\" said Elizabeth Edgerly, senior director of community programs and services with the Alzheimer's Association. \"As the baby boomers age, the disconnect between supply and demand is growing larger.\". The lifetime risk of dementia after age 55 is about 42%, according to a recent study published in the journal Nature Medicine. Around 1 million adults in the U.S. are projected to develop dementia each year by 2060, compared with around 514,000 in 2020, the study found. More than 6 million Americans currently have Alzheimer's disease.The average wait time to see a neurologist is 34 days natio","market":"hk","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":"merge","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LU0079474960.USD","LU1280957306.USD","LU0354030438.USD","LU0708995401.HKD","IE00BK4W5L77.USD","SG9999014914.USD","LU0354030511.USD","LU0096364046.USD","LU0256863811.USD","LU0114720955.EUR","LU1035775433.USD","IE00BJT1NW94.SGD","LU2468319806.SGD","IE00B2B36J28.USD","LU2491050154.USD","ESAIY","LU0097036916.USD","BK4516","SG9999015986.USD","LU1127390331.HKD","SG9999014898.SGD","LU0238689110.USD","LU0820561818.USD","LU0385154629.USD","LU0106261372.USD","LU1057294990.SGD","SGXZ99366536.SGD","BIIB","LU0061475181.USD","LU0882574055.USD","SG9999015945.SGD","LU0320765059.SGD","LU2237443549.SGD","LU1989771016.USD","LU0094547139.USD","IE0009355771.USD","LU2237443465.HKD","LU1983299246.USD","BK4007","LU0943347566.SGD","SGXZ51526630.SGD","IE00B19Z9P08.USD","LU0672654240.SGD","BK4588","LU0203202063.USD","LU0823416689.USD","LU0234570918.USD","LU1366192091.USD","IE00BFTCPJ56.SGD"],"gpt_icon":1},{"id":"2516637209","title":"Pfizer quietly made some big DEI changes","url":"https://stock-news.laohu8.com/highlight/detail?id=2516637209","media":"Quartz","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2516637209?lang=en_us&edition=fundamental","pubTime":"2025-03-01 00:29","pubTimestamp":1740760140,"startTime":"0","endTime":"0","summary":"Pfizer logo is seen on Pfizer World Headquarters in Manhattan, New York, United States of America, on July 6th, 2024. - Image: NurPhoto / Contributor . Pfizer  made some major changes to its diversity, equity, and inclusion  webpage on Thursday, joining other major American corporations that have recently aligned themselves closer with the Trump administration.Other sections of the webpage underwent similar changes. A section previously titled “Diversity in Our Global Supply” has been renamed “Inclusive Supplier Strategy.” The paragraph under this heading now states, “All areas of our business groups are dedicated to finding and selecting the best suppliers,” replacing the previous language that emphasized advancing DEI.Pfizer did not immediately respond to a request for comment from Quartz. However, a company spokesperson told STAT News, which first reported the changes, “We constantly update and evolve the content and design of our website to reflect our current programs, initiatives","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/pfizer-quietly-made-big-dei-162900503.html","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":"yahoofinance","symbols":["SGXZ81514606.USD","JNJ","SG9999014898.SGD","DEI","IE00BVYPNW00.USD","LU0471298694.HKD","LU2361045086.USD","IE00BLSP4452.SGD","LU0096364046.USD","LU0882574055.USD","LU1093756168.USD","LU1670710661.SGD","LU2265009873.SGD","LU1883839398.USD","LU0203345920.USD","LU1323610961.USD","BK4223","LU2129689514.USD","LU1066053197.SGD","LU0417517546.SGD","BK4504","BIIB","LU1066051498.USD","BK4532","LU1057294990.SGD","LU1712237335.SGD","SG9999001440.SGD","LU0109391861.USD","LU2242652126.USD","LU1868836757.USD","BMY","BK4599","BK4581","IE00BVYPNV92.GBP","PFE","LU1430594728.SGD","LU0306807586.USD","LU0238689110.USD","BK4007","SG9999018857.SGD","SG9999002224.SGD","LU0094547139.USD","LU0868494617.USD","LU1674673691.USD","IE00BJLML261.HKD","LU0289739699.SGD","LU2133065610.SGD","LU0061475181.USD","LU2491050154.USD"],"gpt_icon":1},{"id":"2514537332","title":"Biogen, Eisai: CHMP Reaffirms Backing of Leqembi Alzheimer's Drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2514537332","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2514537332?lang=en_us&edition=fundamental","pubTime":"2025-02-28 22:52","pubTimestamp":1740754320,"startTime":"0","endTime":"0","summary":"Biogen and Eisai said the European Medicines Agency's Committee for Medicinal Products for Human Use has reaffirmed its recommended approval of their Alzheimer's drug Leqembi.The companies on Friday said the European Commission, which had asked the panel to consider information on the safety of Leqembi that became available after it adopted a positive opinion in November, will resume its decision-making process for the drug's marketing authorization.The commission last month asked the CHMP to consider whether the new information would require an update of the positive opinion, and to consider whether the wording of the risk minimization measures in the opinion is clear enough to ensure correct implementation.Biogen and Eisai on Friday said the CHMP concluded that its positive opinion didn't need to be updated.The CHMP last July recommended against approval of Leqembi, citing safety and efficacy issues, but Biogen and Eisai asked the panel to take another look, and the CHMP in November ","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://dowjonesnews.com/newdjn/logon.aspx?AL=N","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":["LU0320765992.SGD","LU0109394709.USD","BK4585","LU0889565916.HKD","BK4139","BK4087","IE00B894F039.SGD","BK4532","BK4533","BK4588","BIIB","CHMP","IE00B19Z9P08.USD","LU0234570918.USD","IE00B19Z9Z06.USD"],"gpt_icon":0},{"id":"2514324028","title":"Biogen, Eisai Say EMA Panel Reaffirms Positive Opinion on Lecanemab","url":"https://stock-news.laohu8.com/highlight/detail?id=2514324028","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2514324028?lang=en_us&edition=fundamental","pubTime":"2025-02-28 21:51","pubTimestamp":1740750667,"startTime":"0","endTime":"0","summary":"Biogen  and Eisai said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use reaffirmed its positive opinion on lecanemab for early Alzheimer's disease, allowing the European Commission to resume its review of the drug's marketing application.The companies said the European Commission had asked the committee to reassess lecanemab's safety data and risk minimization measures after issuing its initial opinion in November. The committee determined that no changes were needed, according to the joint statement.Eisai leads the drug's global development and regulatory process, with Biogen co-commercializing and co-promoting it, the companies said.","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":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK4585","BIIB","BK4532","LU0234570918.USD","IE00B894F039.SGD","LU0320765992.SGD","BK4139","LU0109394709.USD","IE00B19Z9Z06.USD","IE00B19Z9P08.USD","BK4533","LU0889565916.HKD","BK4588"],"gpt_icon":0},{"id":"2514032464","title":"The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease","url":"https://stock-news.laohu8.com/highlight/detail?id=2514032464","media":"PR Newswire","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2514032464?lang=en_us&edition=fundamental","pubTime":"2025-02-28 21:23","pubTimestamp":1740748980,"startTime":"0","endTime":"0","summary":"TOKYO and CAMBRIDGE, Mass., Feb. 28, 2025 /PRNewswire/ -- Eisai Co., Ltd.  and Biogen Inc.  announced today that the Committee for Medicinal Products for Human Use  of the European Medicines Agency has reaffirmed its positive opinion by consensus for theanti-Aβ monoclonal antibody lecanemab, adopted in November 2024.1 Following CHMP's reaffirmation, after having considered the additional information requested by the European Commission , the EC will resume the decision-making process for lecanemab's marketing authorization.Lecanemabhas been approved in the U.S.,3Japan,4China,5South Korea,6 Hong Kong,7Israel,8the United Arab Emirates,9the United Kingdom,10 Mexico,11 Macau and Oman,and is under regulatory review in 18 countries and regions including the EU. In January2025,the U.S. Food and Drug Administration  has approved the Supplemental Biologics License Application  for once every four weeks maintenancedosing. In January2025, the submission of","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/committee-medicinal-products-human-chmp-132300937.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/committee-medicinal-products-human-chmp-132300937.html","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":"yahoofinance","symbols":["LU0234570918.USD","BK4201","BK4585","LU0889565916.HKD","IE00B894F039.SGD","IE00B19Z9P08.USD","EC","CHMP","LU0320765992.SGD","MCI","BK4087","BIIB","BK4533","BK4588","BK4532","BK4139","IE00B19Z9Z06.USD","LU0109394709.USD"],"gpt_icon":0},{"id":"2514321173","title":"Biogen, Eisai announces CHMP of EMA reaffirmed positive opinion of lecanemab","url":"https://stock-news.laohu8.com/highlight/detail?id=2514321173","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2514321173?lang=en_us&edition=fundamental","pubTime":"2025-02-28 21:17","pubTimestamp":1740748632,"startTime":"0","endTime":"0","summary":"Eisai (ESAIY) and Biogen (BIIB) announced that the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, has...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/biogen-eisai-announces-chmp-of-ema-reaffirmed-positive-opinion-of-lecanemab?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/biogen-eisai-announces-chmp-of-ema-reaffirmed-positive-opinion-of-lecanemab?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":["BIIB","IE00B19Z9P08.USD","LU0109394709.USD","BK4588","CHMP","BK4585","LU0320765992.SGD","ESAIY","BK4532","IE00B894F039.SGD","BK4533","LU0889565916.HKD","IE00B19Z9Z06.USD","BK4007","BK4087","LU0234570918.USD","BK4139"],"gpt_icon":0},{"id":"2514321887","title":"EU regulator reiterates positive recommendation for Eisai-Biogen's Alzheimer's drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2514321887","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2514321887?lang=en_us&edition=fundamental","pubTime":"2025-02-28 21:13","pubTimestamp":1740748422,"startTime":"0","endTime":"0","summary":"UPDATE 3-EU regulator reiterates positive recommendation for Eisai-Biogen's Alzheimer's drugRewrites headline, adds background on European Commission in paragraph 3. Feb 28  - The European Union's medicines regulator on Friday reiterated its positive recommendation for Eisai 4523.T and Biogen's BIIB.O Alzheimer's drug, Leqembi, after concluding a safety review. The European Medicines Agency  in late January said the European Commission had requested a review of additional safety information for the drug, following its November approval to treat some patients with early Alzheimer's disease.The Commission, which is EU's executive arm, must accept EMA recommendations for new drugs before they are made available to patients. It did not say why it had requested a safety review for Leqembi.Leqembi can cause brain swelling or bleeding, and patients must also undergo an MRI before treatment and several during treatment to monitor this risk, according to the U.S. Food and Drug Administration. T","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:20250228:nL3N3PJ12F:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","BIIB","BK4533","BK4588","IE00B894F039.SGD","IE00B19Z9P08.USD","IE00B19Z9Z06.USD","LU0320765992.SGD","LU0889565916.HKD","LU0109394709.USD","BK4585","LU0234570918.USD","BK4532"],"gpt_icon":0},{"id":"2514326942","title":"EU regulator not updating opinion on Eisai-Biogen's Alzheimer's drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2514326942","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2514326942?lang=en_us&edition=fundamental","pubTime":"2025-02-28 20:48","pubTimestamp":1740746930,"startTime":"0","endTime":"0","summary":"Feb 28  - European Union's human medicines committee  said on Friday it is not updating its opinion on Eisai 4523.T and Biogen's BIIB.O Alzheimer's drug Leqembi, after it recommended its approval in November. The European Commission had asked the CHMP to consider information on the safety of Leqembi.  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