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Tobevibart and Elebsiran Achieve 100% Virologic Suppression at Week 24","url":"https://stock-news.laohu8.com/highlight/detail?id=2484552619","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484552619?lang=en_us&edition=fundamental","pubTime":"2024-11-19 10:15","pubTimestamp":1731982501,"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:20241119:nTUA8F0NGF: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":["BK4585","BK4535","BK4568","BK4139","VIR"],"gpt_icon":0},{"id":"2484956973","title":"Vir Biotechnology Presents Positive Chronic Hepatitis Delta Clinical Trial Data and Announces Initiation of Phase 3 Registrational Program","url":"https://stock-news.laohu8.com/highlight/detail?id=2484956973","media":"Business Wire","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484956973?lang=en_us&edition=fundamental","pubTime":"2024-11-19 10:15","pubTimestamp":1731982500,"startTime":"0","endTime":"0","summary":"– Monthly tobevibart and elebsiran combination achieves rapid 100% virologic suppression at Week 24, sustained through Week 60 –。– Undetectable HDV RNA in 41% of participants at Week 24, increasing to 64% by Week 36 and up to 80% by Week 60 across cohorts –。– Combination well-tolerated: no treatment-related severe AEs, treatment-related discontinuations or ALT flares –。– Following a recent FDA meeting, Phase 3 ECLIPSE registrational program to begin in the first half of 2025 –。These data were presented in an oral session at the American Association for the Study of Liver Diseases  The Liver Meeting, in San Diego, CA. Based on these results, and following a recent meeting with the FDA, Vir Biotechnology plans to initiate the Phase 3 registrational ECLIPSE program in the first half of 2025 to further evaluate the combination of tobevibart and elebsiran for the treatment of CHD.Primary Endpoint Analysis from the Phase 2 SOLSTICE Tria","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/l5oi2o6BXS3LWePoIaxyng--~B/aD0yMzM7dz00ODA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/business-wire.com/4cd04e41299f5f946a2db3e8d5341040","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/l5oi2o6BXS3LWePoIaxyng--~B/aD0yMzM7dz00ODA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/business-wire.com/4cd04e41299f5f946a2db3e8d5341040"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/vir-biotechnology-presents-positive-chronic-021500234.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":["BK4585","HDV","RNA","VIR","LU1878469433.USD","ALT","BK4018","BK4505","BK4079","BK4568","BK4588","BK4139","CHD","BK4535","BK4504","BK4539","COMP"],"gpt_icon":0},{"id":"2484878659","title":"Vir Biotechnology Prospective Treatment for Hepatitis Delta Gets EU Advisory Committee Recommendation","url":"https://stock-news.laohu8.com/highlight/detail?id=2484878659","media":"MT Newswires Live","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484878659?lang=en_us&edition=fundamental","pubTime":"2024-11-19 06:10","pubTimestamp":1731967821,"startTime":"0","endTime":"0","summary":"Vir Biotechnology  late Monday said European regulators are expected to approve its product candidates to treat a relatively rare form of hepatitis and liver disease as an orphan drug.A European Medicines Agency advisory panel recommended approving tobevibart and elebsiran as an orphan drug for the treatment of chronic hepatitis delta. The recommendation follows encouraging preliminary data from a phase 2 trial evaluating the efficacy of the drug combination in adults with hepatitis delta infections.The US Food and Drug Administration in June issued a fast-track designation for the tobevibart and elebsirann, which will expedite the review process.","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":["VIR","BK4139","BK4585","BK4535","BK4156","BK4568"],"gpt_icon":0},{"id":"2484898900","title":"Vir Biotechnology gets positive opinion on orphan drug designation for Tobevibar","url":"https://stock-news.laohu8.com/highlight/detail?id=2484898900","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484898900?lang=en_us&edition=fundamental","pubTime":"2024-11-19 05:10","pubTimestamp":1731964244,"startTime":"0","endTime":"0","summary":"Vir Biotechnology (VIR) “announced that the European Medicines Agency Committee for Orphan Medicinal Products, has issued a positive opinion on the...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/vir-biotechnology-gets-positive-opinion-on-orphan-drug-designation-for-tobevibar?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/vir-biotechnology-gets-positive-opinion-on-orphan-drug-designation-for-tobevibar?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":["BK4568","BK4139","BK4585","VIR","BK4535"],"gpt_icon":0},{"id":"2484591989","title":"Vir Biotechnology Receives Positive Opinion on Orphan Drug Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta From European Medicines Agency","url":"https://stock-news.laohu8.com/highlight/detail?id=2484591989","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484591989?lang=en_us&edition=fundamental","pubTime":"2024-11-19 05:06","pubTimestamp":1731963993,"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:20241118:nFWN3MP1C4:1","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":["BK4585","BK4535","BK4139","VIR","BK4568"],"gpt_icon":0},{"id":"2484987837","title":"Vir Biotechnology Receives Positive Opinion on Orphan Drug Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta from European Medicines Agency","url":"https://stock-news.laohu8.com/highlight/detail?id=2484987837","media":"Business Wire","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484987837?lang=en_us&edition=fundamental","pubTime":"2024-11-19 05:05","pubTimestamp":1731963900,"startTime":"0","endTime":"0","summary":"– Orphan designation in E.U. supports development of treatments for life-threatening or chronically debilitating conditions with significant unmet medical need –。– Phase 2 SOLSTICE 24-week primary endpoint data for tobevibart and elebsiran in chronic hepatitis delta to be presented today at AASLD The Liver Meeting –。SAN FRANCISCO, November 18, 2024----Vir Biotechnology, Inc.  today announced that the European Medicines Agency  Committee for Orphan Medicinal Products , has issued a positive opinion on the application for orphan drug designation of tobevibart and elebsiran for the treatment of chronic hepatitis delta . This opinion is based on encouraging preliminary data from the Phase 2 SOLSTICE trial. Vir Biotechnology will present 24-week data from the Phase 2 SOLSTICE trial at AASLD The Liver Meeting in San Diego, CA, on November 18 at 6.15 p.m. PT. An investor conference call is scheduled for November 19, 2024, at 5.15 a.m. PT / 8.15 a.m. ET.In June 2024, the U.S. Food and Drug Adm","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/7t3Zh_oOq.Ev7QwyfJfJ7A--~B/aD0yMzM7dz00ODA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/business-wire.com/c6e8102cbc679b8da4fd51cdf0d22878","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/7t3Zh_oOq.Ev7QwyfJfJ7A--~B/aD0yMzM7dz00ODA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/business-wire.com/c6e8102cbc679b8da4fd51cdf0d22878"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/vir-biotechnology-receives-positive-opinion-210500380.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":["HDV","LU1878469433.USD","BK4139","BK4079","BK4018","ALT","BK4568","BK4585","BK4588","BK4535","CHD","BK4539","VIR","BK4504","COMP","MDCO"],"gpt_icon":0},{"id":"2483585749","title":"What's Going On With Liver Disease Focused Vir Biotechnology Stock Is Friday?","url":"https://stock-news.laohu8.com/highlight/detail?id=2483585749","media":"Benzinga","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2483585749?lang=en_us&edition=fundamental","pubTime":"2024-11-16 02:39","pubTimestamp":1731695973,"startTime":"0","endTime":"0","summary":"On Friday, Vir Biotechnology, Inc.  announced end-of-treatment data from Part B of the MARCH Phase 2 study evaluating combinations of tobevibart and elebsiran, with or without pegylated interferon alfa , in participants with chronic hepatitis B.Chronic hepatitis B  is a long-lasting, inflammatory liver disease caused by the hepatitis B virus .The World Health Organization estimates that 254 million people live with CHB, and an estimated 1.1 million yearly deaths are associated with the disease.Also Read: Why Is Infectious Disease-Focused Vir Biotechnology Stock Trading Higher On Wednesday?The study demonstrated promising rates of hepatitis B surface antigen  loss  in participants with low baseline HBsAg  in both combination regimens.The doublet and triplet regimens resulted in HBsAg loss at the end of treatment in 39%  and 46%  of participants with baseline HBsAg<1,000 IU/mL, respectively.The proportion of participants with varying baseline HBsAg levels who achieved HBsAg loss at the e","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/OwcgwHvIAPvIG9fTP4OW9Q--~B/aD01NTM7dz05ODM7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/Benzinga/af5e8ee44c196e5291b0d9390662a895","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/OwcgwHvIAPvIG9fTP4OW9Q--~B/aD01NTM7dz05ODM7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/Benzinga/af5e8ee44c196e5291b0d9390662a895"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/whats-going-liver-disease-focused-183933781.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":["BK4535","CHB","BK4585","VIR","BK4568","BK4139"],"gpt_icon":0}],"pageSize":16,"totalPage":8,"pageCount":5,"totalSize":118}]}}