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FDA's late-Q3 2024 warning on potential for substantially reduced. activity of pemivibart through the PEMGARDA Fact Sheet and other media. Though not at previously anticipated rates, PEMGARDA net product revenue grew through the third quarter and continues to grow. Now with a corrected PEMGARDA Fact Sheet removing the aforementioned data reference and including authentic pemivibart data reflecting ongoing neutralization activity against currently circulating variants tested in line with prior variants represented in the CANOPY Phase 3 clinical trial, Invivyd expects ongoing commercial optimization to drive growth.","market":"sh","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":["BK4548","IVVD","BK4568","BK4585","BNTX","BK4588","03160","BK4551","TM","BK4535","BK4099","BK4555","BK4139"],"gpt_icon":0},{"id":"2479774514","title":"Invivyd Phase 3 Long-Term Exploratory Clinical Efficacy Data Shows PEMGARDA™ (pemivibart) Provided Substantial Protection from Symptomatic COVID-19 Versus Placebo Over Six Months of Follow-Up, With No Additional Doses, In Immunocompetent Participants","url":"https://stock-news.laohu8.com/highlight/detail?id=2479774514","media":"GlobeNewswire","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2479774514?lang=en_us&edition=fundamental","pubTime":"2024-10-29 19:01","pubTimestamp":1730199660,"startTime":"0","endTime":"0","summary":"Following strong protection  demonstrated through month 6 with pemivibart, CANOPY clinical trial participants were followed for an additional six-month period , with no additional doses, to assess safety and efficacy as drug concentrations declined over time. In the six-month off-drug follow-up period , substantially reduced concentrations of PEMGARDA reduced the risk of symptomatic COVID-19 by 64% compared to placebo in an immunocompetent adult population, for total twelve-month risk reduction of 76% following two initial pemivibart doses . Months 7-12 follow-up period included the U.S. summer KP.3 and KP.3.1.1 dominant wave, per CDC surveillance. Across all 12 months of the CANOPY clinical trial, Cohort B placebo arm participants experienced an 18% rate of PCR-confirmed symptomatic COVID-19, excluding reinfections, indicative of continued, widespread, uncontrolled virus transmission in the U.S.","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/XQ0zc6GJ0H3IcgQsQ6u6cQ--~B/aD0yNzQ7dz0xODU3O2FwcGlkPXl0YWNoeW9u/https://media.zenfs.com/en/globenewswire.com/e0b6836818161372feda25b028224f9e","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/XQ0zc6GJ0H3IcgQsQ6u6cQ--~B/aD0yNzQ7dz0xODU3O2FwcGlkPXl0YWNoeW9u/https://media.zenfs.com/en/globenewswire.com/e0b6836818161372feda25b028224f9e"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/invivyd-phase-3-long-term-110100669.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":["RRR","BNTX","BK4551","BK4150","IVVD","BK4585","BK4139","BK4588","BK4548","BK4535","BK4568","BK4204","UTI"],"gpt_icon":0},{"id":"2472799323","title":"Invivyd Inc - 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Pemgarda Likely to Retain Activity Against Current Sars-Cov-2 Variants","url":"https://stock-news.laohu8.com/highlight/detail?id=2472323793","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2472323793?lang=en_us&edition=fundamental","pubTime":"2024-10-01 19:01","pubTimestamp":1727780460,"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:20241001:nTUA4H457Q:4","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","IVVD"],"gpt_icon":0},{"id":"2472323216","title":"Invivyd Announces U.S. FDA Has Updated the Pemgarda™ Eua Fact Sheet With Accurate Sars-Cov-2 Variant Susceptibility and Pemgarda Activity Data","url":"https://stock-news.laohu8.com/highlight/detail?id=2472323216","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2472323216?lang=en_us&edition=fundamental","pubTime":"2024-10-01 19:01","pubTimestamp":1727780460,"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:20241001:nTUA4H457Q: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":["IVVD","BK4139"],"gpt_icon":0},{"id":"2469116588","title":"Invivyd Provides Virology Data Supporting Pemivibart's Effectiveness Against Current SARS-CoV-2 Variants","url":"https://stock-news.laohu8.com/highlight/detail?id=2469116588","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2469116588?lang=en_us&edition=fundamental","pubTime":"2024-09-23 20:50","pubTimestamp":1727095853,"startTime":"0","endTime":"0","summary":"Invivyd  said Monday virology data supports its assertion its half-life extended investigational monoclonal antibody PEMGARDA, or pemivibart, is effective against current SARS-CoV-2 variant spike proteins.Invivyd collaborates with LabCorp's Monogram Biosciences to monitor antiviral activity for independent virology assessments, and to deterime if its pemivibart potency needs to be changed as SARS-CoV-2 variants evolve.Shares of the company were up 2.5% in recent Monday premarket activity.Price: 1.2300, Change: +0.03, Percent Change: +2.50","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":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["IVVD","BK4139"],"gpt_icon":0},{"id":"2469919259","title":"Invivyd Provides Detailed Virology Data and Analysis of SARS-CoV-2 Structural Biology Predicting Anticipated Neutralization Activity for PEMGARDA™ (pemivibart)","url":"https://stock-news.laohu8.com/highlight/detail?id=2469919259","media":"GlobeNewswire","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2469919259?lang=en_us&edition=fundamental","pubTime":"2024-09-23 19:01","pubTimestamp":1727089260,"startTime":"0","endTime":"0","summary":"Independent evaluation of KP.3.1.1 and LB.1 variants shows in vitro pseudovirus neutralization potency of PEMGARDA in-line with prior variants tested. Proprietary, ongoing SARS-CoV-2 spike analyses demonstrate consistent structural stability of the pemivibart binding site to date, which has routinely predicted sustained pemivibart in vitro neutralization activity. Invivyd also provided an update to ongoing structural analysis showing no meaningful mutational change in the pemivibart binding site since the Omicron shift late in 2021. These data are presented in Figure 1 below. The pemivibart binding site is defined as a region of amino acid residues on the spike protein within 5 angstroms (5 ) of the interaction between pemivibart and spike protein in a crystal structure and consists of 19 key amino acids. Invivyd’s ongoing genetic and structural analyses of these residues provide the underlying biological rationale for the company’s ongoing expectation for neutralization activity of pe","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/qNyHAMyjlgw7PketnNH5zg--~B/aD0xOTM1O3c9MjE5NzthcHBpZD15dGFjaHlvbg--/https://media.zenfs.com/en/globenewswire.com/294821f376fb04e072782c9abf958e07","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/qNyHAMyjlgw7PketnNH5zg--~B/aD0xOTM1O3c9MjE5NzthcHBpZD15dGFjaHlvbg--/https://media.zenfs.com/en/globenewswire.com/294821f376fb04e072782c9abf958e07"],"rights":null,"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/invivyd-provides-detailed-virology-data-110100325.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":["IVVD"],"gpt_icon":0}],"pageSize":16,"totalPage":6,"pageCount":6,"totalSize":88}]}}