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Declines to Expand Emergency Use Authorization of Co's Covid-19 Drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2513072269","media":"THOMSON REUTERS","labels":["merge"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513072269?lang=en_us&edition=fundamental","pubTime":"2025-02-24 22:32","pubTimestamp":1740407567,"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:20250224:nL3N3PF126:1","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":"reuters_en_live","symbols":["BK4139","IVVD"],"gpt_icon":0},{"id":"2513722885","title":"BUZZ-U.S. STOCKS ON THE MOVE- Twilio, Bath & Body Works, Wingstop","url":"https://stock-news.laohu8.com/highlight/detail?id=2513722885","media":"Reuters","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513722885?lang=en_us&edition=fundamental","pubTime":"2025-02-24 22:25","pubTimestamp":1740407154,"startTime":"0","endTime":"0","summary":"BUZZ-U.S. STOCKS ON THE MOVE-Twilio, Bath & Body Works, WingstopEikon search string for individual stock moves: STXBZThe Day Ahead newsletter: https://refini.tv/3LI4BU7The Morning News Call 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Care Stocks Flat to Higher Pre-Bell Monday","url":"https://stock-news.laohu8.com/highlight/detail?id=2513724103","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513724103?lang=en_us&edition=fundamental","pubTime":"2025-02-24 22:14","pubTimestamp":1740406493,"startTime":"0","endTime":"0","summary":"Health care stocks were flat to higher pre-bell Monday, with the iShares Biotechnology ETF  inactive and The Health Care Select Sector SPDR Fund  up 0.3%.Invivyd  shares were down past 28% after the company said the US Food and Drug Administration rejected its request to expand the existing emergency use authorization for Pemgarda to include treatment of mild-to-moderate COVID-19 in immunocompromised adults and adolescents.Summit Therapeutics  stock was over 5% higher after the company said it will collaborate with Pfizer  on a set of clinical trials to evaluate ivonescimab, its investigational drug, in combination with several Pfizer antibody drug conjugates to treat multiple solid tumors.Entrada Therapeutics  shares were up more than 5% after the company said the US Food and Drug Administration has lifted the clinical hold on ENTR-601-44 and cleared the company's plan to start a phase 1b study of the product candidate as a potential treatment for adults with Duchenne muscular 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Is Maintained at Buy by D. Boral Capital","url":"https://stock-news.laohu8.com/highlight/detail?id=2513817726","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513817726?lang=en_us&edition=fundamental","pubTime":"2025-02-24 20:58","pubTimestamp":1740401880,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/IVVD/analyst-ratings \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  February 24, 2025 07:58 ET (12:58 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":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["IVVD"],"gpt_icon":0},{"id":"2513268187","title":"Invivyd Shares Down as Regulators Decline Expanded Use for Covid-19 Treatment","url":"https://stock-news.laohu8.com/highlight/detail?id=2513268187","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513268187?lang=en_us&edition=fundamental","pubTime":"2025-02-24 20:48","pubTimestamp":1740401280,"startTime":"0","endTime":"0","summary":"Invivyd's stock fell sharply in pre-market trading Monday after U.S. regulators denied a request for its drug Pemgarda to be used in treating Covid-19 in more cases.Shares traded 37% lower ahead of the morning bell at $1.12.The  commercial-stage biopharmaceutical company said its request to expand the existing emergency use authorization of the drug, also called pemivibart, to treat mild-to-moderate Covid-19 in more people was declined by the Food and Drug Administration.Invivyd wanted to expand its use to adults and adolescents who have moderate-to-severe immune compromise due to certain medical conditions such as cancer and organ transplant, where other alternative Covid-19 treatment options weren't possible.The recent denial by the FDA doesn't affect its existing emergency use authorization for pre-exposure prophylaxis of Covid-19 in certain immunocompromised patients, which still remains in effect, Invivyd said.","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":"-1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4548","BK4535","BK4585","BNTX","BK4139","BK4568","IVVD","BK4551","BK4588"],"gpt_icon":0},{"id":"2513725553","title":"Invivyd's Request to Treat Covid-19 Patients With Pemgarda Rejected by US FDA","url":"https://stock-news.laohu8.com/highlight/detail?id=2513725553","media":"MT Newswires Live","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513725553?lang=en_us&edition=fundamental","pubTime":"2025-02-24 20:46","pubTimestamp":1740401199,"startTime":"0","endTime":"0","summary":"Invivyd  said Monday that the US Food and Drug Administration rejected its request to expand the existing emergency use authorization for Pemgarda to include treatment of mild-to-moderate Covid-19 in immunocompromised adults and adolescents.The drug, also called pemivibart, is already being used as a preventative measure for some immunocompromised patients who are not currently sick with Covid-19, the company said.Invivyd said its application for pemivibart as a Covid-19 treatment option was not considered in its current financial guidance and that it plans to publicly share detailed data and regulatory correspondence regarding pemivibart in comparison with other drugs.Shares of the company were down more than 34% in recent premarket activity.","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":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BNTX","BK4551","BK4139","BK4588","BK4548","BK4585","BK4568","BK4535","IVVD"],"gpt_icon":0},{"id":"2513723004","title":"BUZZ-Invivyd falls after US FDA declines to expand emergency use of COVID-19 drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2513723004","media":"Reuters","labels":["policyRegulatory","merge"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513723004?lang=en_us&edition=fundamental","pubTime":"2025-02-24 20:41","pubTimestamp":1740400891,"startTime":"0","endTime":"0","summary":"BUZZ-Invivyd falls after US FDA declines to expand emergency use of COVID-19 drug** Shares of drugmaker Invivyd IVVD.O fall 37.2% to $1.11 premarket** Co says the U.S. FDA has declined to expand the emergency use authorization of its COVID-19 prevention drug ** The expansion was to include those whose immunity is impaired by certain conditions such as cancer and organ transplant, and for whom alternative options are not accessible or appropriate** The drug Pemgarda is already authorized for emergency use in those with compromised immunity due to a medical condition or receiving medicines that suppress the immune system, and unlikely to have an adequate response to vaccination ** IVVD fell 88.8% in 2024  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Patients","url":"https://stock-news.laohu8.com/highlight/detail?id=2513164740","media":"THOMSON REUTERS","labels":["merge"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513164740?lang=en_us&edition=fundamental","pubTime":"2025-02-24 20:05","pubTimestamp":1740398716,"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:20250224:nFWN3PF17D:1","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":"reuters_en_live","symbols":["BK4139","IVVD"],"gpt_icon":0},{"id":"2513017728","title":"FDA Declined Invivyd’s Request to Expand Existing Emergency Use Authorization of PEMGARDA™ (pemivibart) to Include Treatment of Mild-to-Moderate COVID-19 For Immunocompromised Persons Who Have No Alternative Therapeutic Options; No Change to the Existing PEMGARDA EUA for Pre-Exposure Prophylaxis of COVID-19 in Certain Immunocompromised Patients","url":"https://stock-news.laohu8.com/highlight/detail?id=2513017728","media":"GlobeNewswire","labels":["policyRegulatory","merge"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513017728?lang=en_us&edition=fundamental","pubTime":"2025-02-24 20:05","pubTimestamp":1740398700,"startTime":"0","endTime":"0","summary":"FDA’s reasoning appears to center on a belief that COVID-19 treatment immunobridging analyses for a monoclonal antibody  must meet a standard of superior antiviral activity rather than equivalent antiviral activity to past, highly effective, previously authorized and now inactive COVID-19 mAbs in a bridging analysis of sVNA1 titer levels, otherwise the Agency is “unable to reasonably conclude that the known and potential benefits of pemivibart…outweigh the known and potential risks”。“This is a sad day for patients in need. Immunocompromised people who cannot access standard of care are once again left with no option for COVID-19 treatment. Pemivibart, in contrast to all other COVID-19 antibodies ever made, is active and in clinical use today in the U.S. as authorized. Pemivibart is safe enough for certain immunocompromised patients who are not currently sick with COVID-19, but it is now being withheld from those same immunocompromised patients fighting active COVID-19 infection purport","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/fda-declined-invivyd-request-expand-120500563.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"policyRegulatory,merge","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BNTX","BK4551","BK4139","BK4588","BK4548","BK4585","BK4568","BK4535","IVVD"],"gpt_icon":0},{"id":"2512924164","title":"Why Invivyd, Inc. (IVVD) Is Soaring This Year So Far","url":"https://stock-news.laohu8.com/highlight/detail?id=2512924164","media":"Insider Monkey","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512924164?lang=en_us&edition=fundamental","pubTime":"2025-02-18 23:27","pubTimestamp":1739892454,"startTime":"0","endTime":"0","summary":"Nine micro-cap companies and one small-cap firm have been the standout performers on the stock market year-to-date, having registered whopping gains between 200 to 1,200 percent since the start of the year.The list was based on the firms’ share price data from the companies’ closing prices on December 31—the last trading day of 2024—to February 14, 2025.Invivyd, Inc.  saw its year-to-date share prices rally by 263 percent to end Friday’s trading at $1.61 versus the 44 cents registered last December 31, as investor sentiment continues to be fueled by positive developments from its clinical trials.The result further supported the effectiveness of Invivyd, Inc.’s monoclonal antibodies, including Pemgarda .Invivyd, Inc.  officially submitted its latest findings to the Food and Drug Administration , and is expected to update the Pemgarda fact sheet for healthcare providers soon.","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/why-invivyd-inc-ivvd-soaring-152734168.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":["QLD","BK4139","TQQQ","NVIW.SI","SQQQ","NQmain","MNQmain",".IXIC","TSYW.SI","IVVD","QID","USAW.SI","PSQ","USJW.SI"],"gpt_icon":1},{"id":"2509282785","title":"Invivyd partners with football coach Jim Harbaugh for COVID-19 risk awareness","url":"https://stock-news.laohu8.com/highlight/detail?id=2509282785","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2509282785?lang=en_us&edition=fundamental","pubTime":"2025-02-05 22:35","pubTimestamp":1738766108,"startTime":"0","endTime":"0","summary":"Invivyd (IVVD) announced a strategic partnership with professional football coach Jim Harbaugh to raise awareness about the ongoing short and poten...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/invivyd-partners-with-football-coach-jim-harbaugh-for-covid-19-risk-awareness?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/invivyd-partners-with-football-coach-jim-harbaugh-for-covid-19-risk-awareness?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":["IVVD","BK4588","BK4568","BK4551","BK4548","BNTX","BK4535","BK4585","BK4139"],"gpt_icon":0},{"id":"2509284378","title":"Invivyd Announces Partnership With Pro Football Coach Jim Harbaugh to Elevate Awareness and Ongoing Impact of Covid-19: Common, Not a Cold","url":"https://stock-news.laohu8.com/highlight/detail?id=2509284378","media":"THOMSON REUTERS","labels":["corporation"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2509284378?lang=en_us&edition=fundamental","pubTime":"2025-02-05 22:30","pubTimestamp":1738765818,"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:20250205:nTUA8NMVCL:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"corporation","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["IVVD","BK4139"],"gpt_icon":0},{"id":"2508570431","title":"Invivyd Shares Soar Premarket After Tripling Monday Following Initial Results From COVID-19 Vaccination Alternative","url":"https://stock-news.laohu8.com/highlight/detail?id=2508570431","media":"MT Newswires Live","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2508570431?lang=en_us&edition=fundamental","pubTime":"2025-02-04 18:30","pubTimestamp":1738665002,"startTime":"0","endTime":"0","summary":"Invivyd  shares extended gains in premarket activity Tuesday after the company disclosed \"positive\" data from an ongoing phase 1/2 trial of a monoclonal antibody candidate designed to be a \"superior alternative\" to COVID-19 vaccination for the broad population.Phase 1/2 clinical data for VYD2311 to date were \"positive\" for both safety and pharmacokinetics and supported by antiviral activity, the company said Monday. Pooled, blinded adverse events to date were \"mild or moderate.\" As of Day 65, serum concentrations remained high with a half-life not yet reached, indicating the potential long clinical dosing interval.Invivyd said the trial has fully enrolled, and all planned doses have been administered, with only long-term follow-up remaining.The company added that VYD2311 is designed to be \"frontline\" protection in a convenient form while providing a \"potent, long-acting option for the treatment of COVID-19.\"Invivyd shares traded 26% higher in premarket activity after almost tripling in","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":"2","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["IVVD","BK4588","BK4585","BK4551","BNTX","BK4535","BK4548","BK4139","BK4568"],"gpt_icon":1},{"id":"2508018148","title":"Invivyd Is Maintained at Buy by D. Boral Capital","url":"https://stock-news.laohu8.com/highlight/detail?id=2508018148","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2508018148?lang=en_us&edition=fundamental","pubTime":"2025-02-03 21:22","pubTimestamp":1738588920,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/IVVD/analyst-ratings \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  February 03, 2025 08:22 ET (13:22 GMT)","market":"fut","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":["IVVD"],"gpt_icon":0},{"id":"2508147671","title":"Invivyd Announces Positive Phase 1/2 Clinical Data for Vyd2311, a Monoclonal Antibody Designed to Be a Superior Alternative to Covid-19 Vaccination for the Broad Population","url":"https://stock-news.laohu8.com/highlight/detail?id=2508147671","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2508147671?lang=en_us&edition=fundamental","pubTime":"2025-02-03 20:00","pubTimestamp":1738584002,"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:20250203:nTUASLG5H: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":["BK4139","IVVD"],"gpt_icon":0}],"pageSize":16,"totalPage":6,"pageCount":2,"totalSize":83}]}}