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OCGN Stock Pops on Key FDA News. Here’s What to Know.

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Here’s What to Know.","url":"https://stock-news.laohu8.com/highlight/detail?id=1186120067","media":"InvestorPlace","summary":"Biopharmaceutical company Ocugen(NASDAQ:OCGN) announced today that the U.S. Food and Drug Administra","content":"<p>Biopharmaceutical company&nbsp;<b>Ocugen</b>(NASDAQ:<b><u>OCGN</u></b>) announced today that the U.S. Food and Drug Administration (FDA) approved the company’s Investigational New Drug (IND) application for a human clinical trial of OCU400. OCU400 is a gene-therapy candidate targeting several degenerative eye diseases that severely impair vision. Despite the news, OCGN stock is down 6.3% today as investors seem reluctant to buy into the struggling med-tech company.</p>\n<p>Shankar Musunuri, chief executive and co-founder of Ocugen, commented on&nbsp;the significance of this recent development.</p>\n<blockquote>\n <i>“We are delighted to advance OCU400 into clinical trials, which exemplifies our goal of offering new options to people with genetic diseases where none currently exist. … We’re collaborating with leading centers in eye care and have been vital partners to getting our trial launched and receive patients. With this final decision by the FDA, we are embarking on a new pathway of care through this innovative gene therapy.”</i>\n</blockquote>\n<p>The news comes as a welcome change of pace for the company. Ocugen is perhaps best known for its Covid-19 vaccine Covaxin, which largely lags behind the competition. On Nov. 30, the FDA&nbsp;issued a hold&nbsp;on an approval application for late-stage clinical testing of its vaccine.</p>\n<p>Ocugen represents just the North American side of the vaccine’s distribution. Meanwhile,&nbsp;<b>Bharat Biotech</b>, co-developer of the vaccine, has earned approval for use in 17 countries, including the company’s native India. This stands in stark contrast to Ocugen, who many investors believe is&nbsp;too little too late. Ocugen has come under fire for attempting to penetrate largely saturated Western markets as it pertains to vaccine options.</p>\n<p>Will this latest news shake things up for the struggling pharma company?</p>\n<p>OCU400: A Silver Lining for Struggling OCGN stock</p>\n<p>Arguably, OCU400 is Ocugen’s main prize-horse going forward. Anticipation surrounding the company’s breakthrough gene-therapy programs has taken OCGN stock to the moon and back in the past few years. However, that anticipation has largely died down. With many estimating it could be years before such a therapy hits the market, combined with seemingly constant roadblocks for its vaccine candidate, OCGN stock has been on a cold streak for quite a while. Therefore, this news should come as a breath of fresh air for OCGN investors.</p>\n<p>Preliminary estimates see OCU400 being a completely novel solution to a series of retinal degenerative diseases. This year, the European Medicines Agency (EMA) even granted OCU400 a broad medical designation&nbsp;for two different optical diseases.</p>\n<p>While investors currently seem hesitant, hope isn’t lost yet. Positive developments of this nature can create the positive momentum necessary to bring the stock back from the dead.</p>","source":"lsy1606302653667","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>OCGN Stock Pops on Key FDA News. Here’s What to Know.</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nOCGN Stock Pops on Key FDA News. Here’s What to Know.\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-12-10 10:22 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://investorplace.com/2021/12/ocgn-stock-pops-on-key-fda-news-heres-what-to-know/><strong>InvestorPlace</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Biopharmaceutical company Ocugen(NASDAQ:OCGN) announced today that the U.S. Food and Drug Administration (FDA) approved the company’s Investigational New Drug (IND) application for a human clinical ...</p>\n\n<a href=\"https://investorplace.com/2021/12/ocgn-stock-pops-on-key-fda-news-heres-what-to-know/\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"OCGN":"Ocugen"},"source_url":"https://investorplace.com/2021/12/ocgn-stock-pops-on-key-fda-news-heres-what-to-know/","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1186120067","content_text":"Biopharmaceutical company Ocugen(NASDAQ:OCGN) announced today that the U.S. Food and Drug Administration (FDA) approved the company’s Investigational New Drug (IND) application for a human clinical trial of OCU400. OCU400 is a gene-therapy candidate targeting several degenerative eye diseases that severely impair vision. Despite the news, OCGN stock is down 6.3% today as investors seem reluctant to buy into the struggling med-tech company.\nShankar Musunuri, chief executive and co-founder of Ocugen, commented on the significance of this recent development.\n\n“We are delighted to advance OCU400 into clinical trials, which exemplifies our goal of offering new options to people with genetic diseases where none currently exist. … We’re collaborating with leading centers in eye care and have been vital partners to getting our trial launched and receive patients. With this final decision by the FDA, we are embarking on a new pathway of care through this innovative gene therapy.”\n\nThe news comes as a welcome change of pace for the company. Ocugen is perhaps best known for its Covid-19 vaccine Covaxin, which largely lags behind the competition. On Nov. 30, the FDA issued a hold on an approval application for late-stage clinical testing of its vaccine.\nOcugen represents just the North American side of the vaccine’s distribution. Meanwhile, Bharat Biotech, co-developer of the vaccine, has earned approval for use in 17 countries, including the company’s native India. This stands in stark contrast to Ocugen, who many investors believe is too little too late. Ocugen has come under fire for attempting to penetrate largely saturated Western markets as it pertains to vaccine options.\nWill this latest news shake things up for the struggling pharma company?\nOCU400: A Silver Lining for Struggling OCGN stock\nArguably, OCU400 is Ocugen’s main prize-horse going forward. Anticipation surrounding the company’s breakthrough gene-therapy programs has taken OCGN stock to the moon and back in the past few years. However, that anticipation has largely died down. With many estimating it could be years before such a therapy hits the market, combined with seemingly constant roadblocks for its vaccine candidate, OCGN stock has been on a cold streak for quite a while. Therefore, this news should come as a breath of fresh air for OCGN investors.\nPreliminary estimates see OCU400 being a completely novel solution to a series of retinal degenerative diseases. This year, the European Medicines Agency (EMA) even granted OCU400 a broad medical designation for two different optical diseases.\nWhile investors currently seem hesitant, hope isn’t lost yet. Positive developments of this nature can create the positive momentum necessary to bring the stock back from the dead.","news_type":1},"isVote":1,"tweetType":1,"viewCount":837,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":603607902,"gmtCreate":1638403322370,"gmtModify":1638403322494,"author":{"id":"4094041552041320","authorId":"4094041552041320","name":"Choonpoh","avatar":"https://static.laohu8.com/default-avatar.jpg","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4094041552041320","authorIdStr":"4094041552041320"},"themes":[],"htmlText":"Like","listText":"Like","text":"Like","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/603607902","repostId":"1172242285","repostType":2,"isVote":1,"tweetType":1,"viewCount":613,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0}],"hots":[{"id":605923876,"gmtCreate":1639103108708,"gmtModify":1639103108708,"author":{"id":"4094041552041320","authorId":"4094041552041320","name":"Choonpoh","avatar":"https://static.laohu8.com/default-avatar.jpg","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4094041552041320","authorIdStr":"4094041552041320"},"themes":[],"htmlText":"666","listText":"666","text":"666","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":6,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/605923876","repostId":"1186120067","repostType":2,"isVote":1,"tweetType":1,"viewCount":837,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0},{"id":603607902,"gmtCreate":1638403322370,"gmtModify":1638403322494,"author":{"id":"4094041552041320","authorId":"4094041552041320","name":"Choonpoh","avatar":"https://static.laohu8.com/default-avatar.jpg","crmLevel":1,"crmLevelSwitch":0,"followedFlag":false,"idStr":"4094041552041320","authorIdStr":"4094041552041320"},"themes":[],"htmlText":"Like","listText":"Like","text":"Like","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://laohu8.com/post/603607902","repostId":"1172242285","repostType":2,"repost":{"id":"1172242285","pubTimestamp":1637969411,"share":"https://www.laohu8.com/m/news/1172242285?lang=&edition=full","pubTime":"2021-11-27 07:30","market":"us","language":"en","title":"OCGN Stock Alert: The FDA News Sending Ocugen Plummeting Today","url":"https://stock-news.laohu8.com/highlight/detail?id=1172242285","media":"InvestorPlace","summary":"Shares of biotech company Ocugen(NASDAQ:OCGN) are sharply lower today on news that the U.S. Food and","content":"<p>Shares of biotech company&nbsp;<b>Ocugen</b>(NASDAQ:<b><u>OCGN</u></b>) are sharply lower today on news that the U.S. Food and Drug Administration has halted its investigational new drug application for Covaxin, a vaccine for Covid-19.</p>\n<p>In anews release, Ocugen said that the FDA still needs to inform it of the reasons why the Covaxin application has been halted and what the company needs to do to address the issues or deficiencies that have arisen. Ocugen said it will work to answer any questions the FDA has and resolve the problems as quickly as possible.</p>\n<p>However, news that Covaxin’s progress toward approval and commercialization has been stopped has OCGN stock down 10% today to $6.42 per share. Year to date, the stock remains up more than 100%, though most of that gain came in the first quarter. Over the past six months, Ocugen’s share price has actually declined 18%.</p>\n<p>What Happened With OCGN Stock</p>\n<p>Covaxin is Malvern, Pennsylvania-based Ocugen’s major commercialization candidate. Covaxin was actually developed by&nbsp;<b>Bharat Biotech,</b>an Indian pharmaceutical company that specializes in vaccines. Essentially, Covaxin is the domestically developed Covid-19vaccine in India. Ocugen has been trying to get it approved for use in the U.S. and Canada. However, the FDA has now put a halt to Covaxin’s progress toward receiving approval in America, casting doubts on Ocugen’s strategy and hurting its share price.</p>\n<p>That the reasons for the FDA stopping Covaxin’s progress haven’t been made public adds to the uncertainty surrounding Ocugen.</p>\n<p>Investors should also note that some critics have called into question Covaxin’slower efficacy against the delta variantcompared to vaccines from&nbsp;<b>Pfizer</b>(NYSE:<b><u>PFE</u></b>) and&nbsp;<b>Moderna</b>(NASDAQ:<b><u>MRNA</u></b>). However, others have said it is not a problem.</p>\n<p>Why It Matters</p>\n<p>Ocugen is not your typical biotechnology or pharmaceutical company. It is primarily focused on treating eye diseases and says on its website that its focus is to“cure blindness.”The company jumped on the Covid-19 vaccine train at the outset of the pandemic as the biotech and pharmaceutical industries raced to develop treatments against the deadly illness. However, rather than develop its own vaccine, Ocugen focused on trying to commercialize Covaxin in the U.S. Critics havecalled this strategy into question.</p>\n<p>For Ocugen, the FDA halting progress of Covaxin makes it less likely that the Covid-19 vaccine will become available in the U.S. This reality is putting additional pressure on OCGN stock at a time when it was already in decline. While Ocugen’s share price has been as high as $18.77 this year, most of the increases were the result of it being treated as ameme stockby the retail investors. In January of this year, at the height of the meme stock craze, Ocugen’s stock jumped 769% in a matter of days, climbing to $15.81 from just $1.82.</p>\n<p>What’s Next for Ocugen</p>\n<p>The FDA’s action is bad news for Ocugen as it lessens the likelihood that Covaxin will become commercially available in the U.S. In the near term, OCGN stock is likely to decline further. Beyond good news from regulators, hope rests with retail investors pumping shares up again.</p>","source":"lsy1606302653667","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>OCGN Stock Alert: The FDA News Sending Ocugen Plummeting Today</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nOCGN Stock Alert: The FDA News Sending Ocugen Plummeting Today\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-11-27 07:30 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://investorplace.com/2021/11/ocgn-stock-alert-the-fda-news-sending-ocugen-plummeting-today/><strong>InvestorPlace</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Shares of biotech company Ocugen(NASDAQ:OCGN) are sharply lower today on news that the U.S. Food and Drug Administration has halted its investigational new drug application for Covaxin, a vaccine for ...</p>\n\n<a href=\"https://investorplace.com/2021/11/ocgn-stock-alert-the-fda-news-sending-ocugen-plummeting-today/\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"OCGN":"Ocugen"},"source_url":"https://investorplace.com/2021/11/ocgn-stock-alert-the-fda-news-sending-ocugen-plummeting-today/","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1172242285","content_text":"Shares of biotech company Ocugen(NASDAQ:OCGN) are sharply lower today on news that the U.S. Food and Drug Administration has halted its investigational new drug application for Covaxin, a vaccine for Covid-19.\nIn anews release, Ocugen said that the FDA still needs to inform it of the reasons why the Covaxin application has been halted and what the company needs to do to address the issues or deficiencies that have arisen. Ocugen said it will work to answer any questions the FDA has and resolve the problems as quickly as possible.\nHowever, news that Covaxin’s progress toward approval and commercialization has been stopped has OCGN stock down 10% today to $6.42 per share. Year to date, the stock remains up more than 100%, though most of that gain came in the first quarter. Over the past six months, Ocugen’s share price has actually declined 18%.\nWhat Happened With OCGN Stock\nCovaxin is Malvern, Pennsylvania-based Ocugen’s major commercialization candidate. Covaxin was actually developed by Bharat Biotech,an Indian pharmaceutical company that specializes in vaccines. Essentially, Covaxin is the domestically developed Covid-19vaccine in India. Ocugen has been trying to get it approved for use in the U.S. and Canada. However, the FDA has now put a halt to Covaxin’s progress toward receiving approval in America, casting doubts on Ocugen’s strategy and hurting its share price.\nThat the reasons for the FDA stopping Covaxin’s progress haven’t been made public adds to the uncertainty surrounding Ocugen.\nInvestors should also note that some critics have called into question Covaxin’slower efficacy against the delta variantcompared to vaccines from Pfizer(NYSE:PFE) and Moderna(NASDAQ:MRNA). However, others have said it is not a problem.\nWhy It Matters\nOcugen is not your typical biotechnology or pharmaceutical company. It is primarily focused on treating eye diseases and says on its website that its focus is to“cure blindness.”The company jumped on the Covid-19 vaccine train at the outset of the pandemic as the biotech and pharmaceutical industries raced to develop treatments against the deadly illness. However, rather than develop its own vaccine, Ocugen focused on trying to commercialize Covaxin in the U.S. Critics havecalled this strategy into question.\nFor Ocugen, the FDA halting progress of Covaxin makes it less likely that the Covid-19 vaccine will become available in the U.S. This reality is putting additional pressure on OCGN stock at a time when it was already in decline. While Ocugen’s share price has been as high as $18.77 this year, most of the increases were the result of it being treated as ameme stockby the retail investors. In January of this year, at the height of the meme stock craze, Ocugen’s stock jumped 769% in a matter of days, climbing to $15.81 from just $1.82.\nWhat’s Next for Ocugen\nThe FDA’s action is bad news for Ocugen as it lessens the likelihood that Covaxin will become commercially available in the U.S. In the near term, OCGN stock is likely to decline further. Beyond good news from regulators, hope rests with retail investors pumping shares up again.","news_type":1},"isVote":1,"tweetType":1,"viewCount":613,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"CN","totalScore":0}],"lives":[]}