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Novavax

6.67

-0.4000-5.66%

Post-market: 6.61-0.0600-0.90%19:59 EDT

Volume:13.19M

Turnover:88.19M

Market Cap:1.07B

PE:-5.41

High:7.17

Open:6.99

Low:6.12

Close:7.07

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Overview Company News Filings

Stock Track | Novavax Shares Plummet 10.40% as FDA Demands New Clinical Trial for Covid-19 Vaccine

Market Chatter: Novavax Asked by FDA to Run Additional Trial on COVID-19 Vaccine

MT Newswires Live

BUZZ-Novavax falls after report FDA demands new trial for COVID vaccine

Moderna Shares Lose Ground With Volume Spick in Late Afternoon, Last Down 2%; Pfizer Shares Lose Some Steam, Last up 0.6%

THOMSON REUTERS

FDA asks Novavax to complete new clinical trial for delayed COVID-19 shot, WSJ reports

Novavax asked for new Covid-19 vaccine trial by FDA, WSJ reports

Novavax asked by FDA to complete additional COVID trial, WSJ says

Stock Track | Novavax Shares Plummet 10.40% as FDA Demands New Clinical Trial for Delayed Covid-19 Vaccine

BRIEF-FDA Asks Vaccine Maker Novavax To Complete New Clinical Trial For Delayed Covid-19 Shot - WSJ

FDA Asks Vaccine Maker Novavax to Complete New Clinical Trial for Delayed Covid-19 Shot - WSJ

THOMSON REUTERS

Novavax Inc. Stock Underperforms Thursday When Compared To Competitors

Stock Track | Novavax Plummets 5% as FDA Delays COVID Vaccine Approval Amid Efficacy Concerns

Novavax (NVAX) Surges 19.5%: Is This an Indication of Further Gains?

Equity Markets Close Higher Over Potential Reduction in US Tariffs on China

MT Newswires Live

Novavax Shares Surge 17% as FDA Requests Postmarketing Data for COVID-19 Vaccine

Stock Track | Novavax Soars 17% as COVID-19 Vaccine Nears Potential FDA Approval

Novavax Shares up 15% After Co Says Covid-19 Vaccine Is Approvable Based on Conversations With the US FDA

THOMSON REUTERS

Novavax Says COVID Vaccine Application 'Approvable'

MT Newswires Live

FDA Asks Novavax for Commitment on Post-Approval Studies for COVID Vaccine

BUZZ-Novavax rises after saying its COVID-19 vaccine 'approvable' based on FDA talks

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This setback comes at a crucial time for the biotechnology company, which has been wo","market":"nz","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":"","theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":"Stock Track | Novavax Shares Plummet 10.40% as FDA Demands New Clinical Trial for Covid-19 Vaccine","news_tag":"movement","news_rank":0,"length":0,"strategy_id":0,"source":"ai_movement_en","symbols":["NVAX"],"gpt_icon":0},{"id":"2530160683","title":"Market Chatter: Novavax Asked by FDA to Run Additional Trial on COVID-19 Vaccine","url":"https://stock-news.laohu8.com/highlight/detail?id=2530160683","media":"MT Newswires Live","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2530160683?lang=en_us&edition=fundamental","pubTime":"2025-04-26 04:22","pubTimestamp":1745612571,"startTime":"0","endTime":"0","summary":"Novavax  was asked by the US Food and Drug Administration to run an additional randomized clinical trial on its COVID-19 vaccine, The Wall Street Journal reported Friday, citing people familiar with the matter.That may cost the company tens of millions of dollars, vaccine experts said, according to the report.The vaccine had showed 90% efficacy in a 30,000-person, placebo-controlled trial, the report said.The FDA request allows the company to negotiate for a smaller, less expensive study, the report said, citing a person familiar with the matter.The Department of Health and Human Services and Novavax didn't immediately respond to requests for comment from MT Newswires.Novavax shares fell 1.4% in after-hours trading after dropping 5.7% in the regular session.","market":"fut","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":["BK4548","BK4585","NVAX","BK4547","BK4139","BK4568","BK4588","BK4535","BNTX","BK4551"],"gpt_icon":1},{"id":"2530916215","title":"BUZZ-Novavax falls after report FDA demands new trial for COVID vaccine","url":"https://stock-news.laohu8.com/highlight/detail?id=2530916215","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2530916215?lang=en_us&edition=fundamental","pubTime":"2025-04-26 03:46","pubTimestamp":1745610377,"startTime":"0","endTime":"0","summary":"BUZZ-Novavax falls after report FDA demands new trial for COVID vaccine** Shares of vaccine maker Novavax NVAX.O fall 6.6% to $6.61 in afternoon trading** US FDA is asking Novavax to conduct an additional clinical trial for its COVID-19 vaccine, despite previous 90% efficacy results, the Wall Street Journal reports, citing people familiar with the matter** The request came after appointees under Health Secretary Robert F. Kennedy Jr. intervened in the approval process - WSJ** Novavax did not immediately respond to a Reuters request for comment** On Wednesday, NVAX said US FDA asked the company to produce more data on its COVID-19 vaccine if it gets full approval** Including session's moves, stock down 12.3% YTD","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:20250425:nL4N3R31UK:1","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":["BK4139","BK4588","BK4547","NVAX","BK4568","BK4585"],"gpt_icon":1},{"id":"2530162565","title":"Moderna Shares Lose Ground With Volume Spick in Late Afternoon, Last Down 2%; Pfizer Shares Lose Some Steam, Last up 0.6%","url":"https://stock-news.laohu8.com/highlight/detail?id=2530162565","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2530162565?lang=en_us&edition=fundamental","pubTime":"2025-04-26 03:43","pubTimestamp":1745610181,"startTime":"0","endTime":"0","summary":null,"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:20250425:nL1N3R312I: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":["SG9999002232.USD","BK4551","LU0321505868.SGD","LU1023059063.AUD","BK4585","BK4534","BK4139","LU1057294990.SGD","SG9999002224.SGD","BK4007","LU0058720904.USD","BK4548","BK4581","LU0306807586.USD","SG9999011175.SGD","BK4568","LU1066051498.USD","LU0456855351.SGD","BK4533","SG9999003800.SGD","MRNA","LU0321505439.SGD","LU0122379950.USD","LU1894683348.USD","LU0225771236.USD","BK4550","BK4547","BK4532","LU0306806265.USD","NVAX","BK4592","SG9999013999.USD","IE00BBT3K403.USD","SG9999001176.SGD","LU0289739699.SGD","LU1894683264.USD","LU0170899867.USD","LU1066053197.SGD","LU0985481810.HKD","SG9999001176.USD","IE00B19Z3B42.SGD","SGXZ57979304.SGD","IE00BLSP4239.USD","IE0002270589.USD","LU1883839398.USD","IE000M9KFDE8.USD","IE00B19Z3581.USD","PFE","BK4588","IE00BLSP4452.SGD"],"gpt_icon":0},{"id":"2530164423","title":"FDA asks Novavax to complete new clinical trial for delayed COVID-19 shot, WSJ reports","url":"https://stock-news.laohu8.com/highlight/detail?id=2530164423","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2530164423?lang=en_us&edition=fundamental","pubTime":"2025-04-26 03:30","pubTimestamp":1745609444,"startTime":"0","endTime":"0","summary":"FDA asks Novavax to complete new clinical trial for delayed COVID-19 shot, WSJ reportsApril 25  - Federal regulators are asking Novavax NVAX.O to complete an additional clinical trial on its Covid-19 vaccine after previously delaying approval, the Wall Street Journal reported on Friday, citing people familiar with the matter.","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:20250425:nL4N3R31U6:1","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":["BK4547","BK4585","BK4139","BK4568","BK4588","NVAX"],"gpt_icon":1},{"id":"2530620411","title":"Novavax asked for new Covid-19 vaccine trial by FDA, WSJ reports","url":"https://stock-news.laohu8.com/highlight/detail?id=2530620411","media":"TIPRANKS","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2530620411?lang=en_us&edition=fundamental","pubTime":"2025-04-26 03:30","pubTimestamp":1745609427,"startTime":"0","endTime":"0","summary":"Federal regulators have asked Novavax (NVAX) to conduct another randomized clinical trial of its Covid-19 vaccine following earlier delays in appro...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/novavax-asked-for-new-covid-19-vaccine-trial-by-fda-wsj-reports?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/novavax-asked-for-new-covid-19-vaccine-trial-by-fda-wsj-reports?utm_source=itigerup.com&utm_medium=referral","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":"tipranks_highlight","symbols":["BK4139","US3Y.BOND","BK4588","BK4585","US2Y.BOND","US6M.BOND","BK4548","BK4535","US10Y.BOND","BK4547","US12M.BOND","NVAX","BK4551","US30Y.BOND","US5Y.BOND","BNTX","US7Y.BOND","BK4568"],"gpt_icon":0},{"id":"2530167355","title":"Novavax asked by FDA to complete additional COVID trial, WSJ says","url":"https://stock-news.laohu8.com/highlight/detail?id=2530167355","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2530167355?lang=en_us&edition=fundamental","pubTime":"2025-04-26 03:25","pubTimestamp":1745609157,"startTime":"0","endTime":"0","summary":"15:23 EDT Novavax (NVAX) asked by FDA to complete additional COVID trial, WSJ says Published first on TheFly – the ultimate source for real-time, m...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/novavax-asked-by-fda-to-complete-additional-covid-trial-wsj-says?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/novavax-asked-by-fda-to-complete-additional-covid-trial-wsj-says?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":["BK4547","NVAX","BK4568","BK4585","BK4588","BK4139"],"gpt_icon":0},{"id":"1185713988","title":"Stock Track | Novavax Shares Plummet 10.40% as FDA Demands New Clinical Trial for Delayed Covid-19 Vaccine","url":"https://stock-news.laohu8.com/highlight/detail?id=1185713988","media":"Stock Track","labels":["movement"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1185713988?lang=en_us&edition=fundamental","pubTime":"2025-04-26 03:24","pubTimestamp":1745609070,"startTime":"0","endTime":"0","summary":"Shares of Novavax  plunged 10.40% in intraday trading on Friday following news that the U.S. Food and Drug Administration  has requested the company to complete a new clinical trial for its delayed Covid-19 vaccine. This development has sent shockwaves through the market, causing investors to reassess their positions in the biotechnology firm.The requirement for a new clinical trial suggests that the FDA may have concerns about the existing data or manufacturing processes related to Novavax's va","market":"hk","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":"","theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"movement","news_rank":0,"length":0,"strategy_id":0,"source":"ai_movement_en","symbols":["NVAX"],"gpt_icon":0},{"id":"2530164383","title":"BRIEF-FDA Asks Vaccine Maker Novavax To Complete New Clinical Trial For Delayed Covid-19 Shot - WSJ","url":"https://stock-news.laohu8.com/highlight/detail?id=2530164383","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2530164383?lang=en_us&edition=fundamental","pubTime":"2025-04-26 03:22","pubTimestamp":1745608978,"startTime":"0","endTime":"0","summary":"BRIEF-FDA Asks Vaccine Maker Novavax To Complete New Clinical Trial For Delayed Covid-19 Shot - WSJApril 25 (Reuters) - FDA ASKS VACCINE MAKER NOVAVAX TO COMPLETE NEW CLINICAL TRIAL FOR DELAYED COVID-","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:20250425:nFWN3R32GZ:1","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":["BK4568","BK4547","BK4588","BK4139","NVAX","BK4585"],"gpt_icon":0},{"id":"2530841164","title":"FDA Asks Vaccine Maker Novavax to Complete New Clinical Trial for Delayed Covid-19 Shot - WSJ","url":"https://stock-news.laohu8.com/highlight/detail?id=2530841164","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2530841164?lang=en_us&edition=fundamental","pubTime":"2025-04-26 03:21","pubTimestamp":1745608888,"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:20250425:nFWN3R32GZ: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","BK4585","BK4588","BK4568","BK4547","NVAX"],"gpt_icon":0},{"id":"2530991590","title":"Novavax Inc. Stock Underperforms Thursday When Compared To Competitors","url":"https://stock-news.laohu8.com/highlight/detail?id=2530991590","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2530991590?lang=en_us&edition=fundamental","pubTime":"2025-04-25 05:27","pubTimestamp":1745530020,"startTime":"0","endTime":"0","summary":"This article was automatically generated by MarketWatch using technology from Automated Insights.Shares of Novavax Inc.  slid 5.35% to $7.07 Thursday, on what proved to be an all-around favorable trading session for the stock market, with the NASDAQ Composite Index  rising 2.74% to 17,166.04 and the Dow Jones Industrial Average  rising 1.23% to 40,093.40.The stock's fall snapped a three-day winning streak.Novavax Inc. closed 70.37% short of its 52-week high of $23.86, which the company reached on June 6th.The stock underperformed when compared to some of its competitors Thursday, as Johnson & Johnson  fell 0.29% to $154.93, Pfizer Inc.  rose 1.74% to $22.78, and Merck & Co. Inc.  rose 1.40% to $79.84.Trading volume  eclipsed its 50-day average volume of 5.3 M.Data source: Dow Jones Market Data, FactSet. Data compiled April 24, 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 S","market":"hk","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":["NVAX"],"gpt_icon":1},{"id":"1110381703","title":"Stock Track | Novavax Plummets 5% as FDA Delays COVID Vaccine Approval Amid Efficacy Concerns","url":"https://stock-news.laohu8.com/highlight/detail?id=1110381703","media":"Stock Track","labels":["movement"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1110381703?lang=en_us&edition=fundamental","pubTime":"2025-04-24 22:06","pubTimestamp":1745503608,"startTime":"0","endTime":"0","summary":"Novavax  shares plummeted 5.02% in Thursday's pre-market trading session following news of delayed approval for its COVID-19 vaccine and growing concerns about its efficacy. The biotech company, which offers the only non-mRNA COVID-19 booster option in the United States, faces an uncertain future as its current batch of boosters is set to expire on April 30.Despite the setback, thousands of Americans, particularly those with long COVID and those who cannot or will not take mRNA vaccines, continu","market":"nz","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":"","theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":"Stock Track | Novavax Plummets 5% as FDA Delays COVID Vaccine Approval Amid Efficacy Concerns","news_tag":"movement","news_rank":0,"length":0,"strategy_id":0,"source":"ai_movement_en","symbols":["NVAX"],"gpt_icon":0},{"id":"2529249726","title":"Novavax (NVAX) Surges 19.5%: Is This an Indication of Further Gains?","url":"https://stock-news.laohu8.com/highlight/detail?id=2529249726","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2529249726?lang=en_us&edition=fundamental","pubTime":"2025-04-24 13:48","pubTimestamp":1745473680,"startTime":"0","endTime":"0","summary":"Novavax NVAX shares rallied 19.5% in the last trading session to close at $7.47. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 17.3% loss over the past four weeks.The rise in share price comes after the vaccine-maker announced that the FDA has requested additional data on its protein-based COVID-19 vaccine as part of a post-marketing commitment. Although this signals a delay in full approval, investors took the news as a positive sign that the regulatory process is progressing and that the vaccine remains on track for eventual full approval.This vaccine maker is expected to post quarterly earnings of $0.19 per share in its upcoming report, which represents a year-over-year change of +118.1%. Revenues are expected to be $71.84 million, down 23.5% from the year-ago quarter.","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/novavax-nvax-surges-19-5-054800239.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["NVAX","BK4139","BK4551","BK4547","BK4535","BK4588","BNTX","BK4548","BK4568","BK4585"],"gpt_icon":0},{"id":"2529668102","title":"Equity Markets Close Higher Over Potential Reduction in US Tariffs on China","url":"https://stock-news.laohu8.com/highlight/detail?id=2529668102","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2529668102?lang=en_us&edition=fundamental","pubTime":"2025-04-24 04:16","pubTimestamp":1745439372,"startTime":"0","endTime":"0","summary":"US benchmark equity indexes closed higher on Wednesday as markets showed optimistism on President Donald Trump's offer to reduce US tariffs on China.The Nasdaq Composite increased 2.3% to 16,670.20, w","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://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":["MNQmain","DXD","SQQQ","GB00B4LPDJ14.GBP","QLD","SG9999015978.USD","USAW.SI","SH","TSYW.SI","USJW.SI","NQmain","PSQ","EQR","NVAX","SSO","VOO","SDS","IE00B4JS1V06.HKD",".SPX",".DJI","LU2065171311.SGD","LU2168564495.EUR","IVV","DDM","DOG","TQQQ","APH","SPXU","ESmain","APH.AU","NVIW.SI","QID","ENPH","UDOW",".IXIC","LU1435385759.SGD","LU1791710582.SGD","DJX","PLTR","OEF","OEX","SDOW","LU0234570918.USD","LU0792757196.USD","IE00BKPKM429.USD","SPY"],"gpt_icon":1},{"id":"2529668166","title":"Novavax Shares Surge 17% as FDA Requests Postmarketing Data for COVID-19 Vaccine","url":"https://stock-news.laohu8.com/highlight/detail?id=2529668166","media":"GuruFocus.com","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2529668166?lang=en_us&edition=fundamental","pubTime":"2025-04-24 04:04","pubTimestamp":1745438697,"startTime":"0","endTime":"0","summary":"Novavax  shares jumped 17.1% to $7.32 as of 1:10 p.m. ET on Wednesday after the company said it received a request from the U.S. Food and Drug Administration for additional postmarketing clinical data related to its COVID-19 vaccine license application.GuruFocus has detected 3 Warning Signs with NVAX.The company said the FDA issued a formal information request tied to its Biologics License Application  and asked for a postmarketing commitment. Novavax said it aims to respond promptly to move the vaccine closer to full regulatory approval.The request comes after the April 1 Prescription Drug User Fee Act deadline, during which Novavax said it had constructive discussions with the agency.Novavax stated that while it believes its application is approvable, final approval remains contingent on meeting the FDA's requirements.","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/novavax-shares-surge-17-fda-200457518.html","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":"yahoofinance","symbols":["BK4139","BK4568","BK4585","BNTX","BK4548","BK4547","NVAX","BK4551","BK4535","BK4588"],"gpt_icon":0},{"id":"1151315098","title":"Stock Track | Novavax Soars 17% as COVID-19 Vaccine Nears Potential FDA Approval","url":"https://stock-news.laohu8.com/highlight/detail?id=1151315098","media":"Stock Track","labels":["movement"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/1151315098?lang=en_us&edition=fundamental","pubTime":"2025-04-23 21:43","pubTimestamp":1745415802,"startTime":"0","endTime":"0","summary":"Novavax  stock skyrocketed 17.28% in early trading on Wednesday, following positive developments in the company's pursuit of FDA approval for its COVID-19 vaccine. The surge comes amid renewed optimism about the potential authorization of Novavax's Biologics License Application .In a recent SEC filing, Novavax revealed that the U.S. Food and Drug Administration  has requested a post-marketing commitment  for additional clinical data on its COVID-19 vaccine. Despite this request, the company rema","market":"nz","thumbnail":"","type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":"","theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"movement","news_rank":0,"length":0,"strategy_id":0,"source":"ai_movement_en","symbols":["NVAX"],"gpt_icon":0},{"id":"2529686732","title":"Novavax Shares up 15% After Co Says Covid-19 Vaccine Is Approvable Based on Conversations With the US FDA","url":"https://stock-news.laohu8.com/highlight/detail?id=2529686732","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2529686732?lang=en_us&edition=fundamental","pubTime":"2025-04-23 21:31","pubTimestamp":1745415075,"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:20250423:nFWN3R119S: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","BK4585","BK4588","BK4568","BK4547","NVAX"],"gpt_icon":0},{"id":"2529688883","title":"Novavax Says COVID Vaccine Application 'Approvable'","url":"https://stock-news.laohu8.com/highlight/detail?id=2529688883","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2529688883?lang=en_us&edition=fundamental","pubTime":"2025-04-23 20:45","pubTimestamp":1745412308,"startTime":"0","endTime":"0","summary":"Novavax  said Wednesday it believes its biologics license application for its COVID-19 vaccine is \"approvable\" by the US Food and Drug Administration based on ongoing discussions.The company said the FDA recently asked for a post-marketing commitment to collect additional clinical data.Novavax said it will work quickly to comply with the request and obtain final approval.Shares of Novavax rose 12% in recent premarket activity Wednesday.","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":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK4139","BK4588","BK4568","BK4585","BK4547","NVAX"],"gpt_icon":0},{"id":"2529050762","title":"FDA Asks Novavax for Commitment on Post-Approval Studies for COVID Vaccine","url":"https://stock-news.laohu8.com/highlight/detail?id=2529050762","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2529050762?lang=en_us&edition=fundamental","pubTime":"2025-04-23 20:33","pubTimestamp":1745411602,"startTime":"0","endTime":"0","summary":"UPDATE 1-FDA asks Novavax for commitment on post-approval studies for COVID vaccineAdds shares in paragraph 2, details in paragraphs 3,4 and 5April 23  - Novavax NVAX.O said on Wednesday the U.S. Food and Drug Administration has sought a commitment from the COVID-19 vaccine maker for additional clinical data if it approves the shot.Shares of the biotech rose 12% to $7.07 in premarket trading. The FDA had missed its deadline for making a decision on traditional approval for the company's protein-based shot earlier this month. Novavax said it believes that the company's marketing application is \"approvable\" based on its conversations with the FDA.   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after saying its COVID-19 vaccine 'approvable' based on FDA talks**  Shares of vaccine maker Novavax NVAX.O rise  13% to $7.06 premarket** Co says its COVID-19 vaccine is \"approvable based on conversations with the U.S. Food and Drug Administration \"** NVAX also says it has received a request from the FDA for a commitment to provide additional clinical data on its vaccine if it secures an approval**  The FDA had missed its deadline for making a decision on traditional approval for co's protein-based shot earlier this month** Up to last close, stock had fallen 22.3% 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