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2021-09-15

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ObsEva Announces Submission of New Drug Application to U.S. FDA for Linzagolix for the Treatment of Uterine Fibroids

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13:00","market":"us","language":"en","title":"ObsEva Announces Submission of New Drug Application to U.S. FDA for Linzagolix for the Treatment of Uterine Fibroids","url":"https://stock-news.laohu8.com/highlight/detail?id=2167569486","media":"StreetInsider","summary":"-If approved, linzagolix will be the only GnRH antagonist with flexible dose regimen options to addr","content":"<p><i>-If approved, linzagolix will be the only GnRH antagonist with flexible dose regimen</i> <i>options to address the clinical needs of more women with uterine fibroids-</i></p>\n<p><i>-NDA submission</i> <i>includes positive data from Phase 3 PRIMROSE trials</i> <i>up to 52 weeks on treatment and 24 weeks post-treatment follow-up results-</i></p>\n<p><i>-EU MAA CHMP recommendation anticipated in Q4 2021-</i></p>\n<p>Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange</p>\n<p><b>GENEVA, Switzerland– September 15, 2021 </b>– ObsEva SA (NASDAQ: OBSV) (SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for linzagolix for the treatment of uterine fibroids. Linzagolix is an oral GnRH receptor antagonist with potential best-in-class efficacy, favorable tolerability profile, and unique and flexible dosing options. Further, if approved, linzagolix will be the only GnRH antagonist in uterine fibroids with a low dose non-add-back therapy (ABT) option.</p>\n<p>The NDA submission includes the positive 52-week on treatment results from the Phase 3 PRIMROSE 1 (US only; n=574) and PRIMROSE 2 (Europe and US; n=535) clinical studies as well as supportive results from the 76-week post-treatment follow-up study. In both studies, patients with heavy menstrual bleeding (HMB) associated with uterine fibroids were administered linzagolix doses of 100 mg or 200 mg, with and without hormonal add-back-therapy (ABT; 1 mg estradiol/0.5 mg norethindrone acetate), or placebo. PRIMROSE 1 and 2 successfully met their primary endpoints, with all doses showing statistically significant and clinically relevant reductions in HMB compared to placebo.</p>\n<p>“The NDA submission is a major milestone in making linzagolix available in the U.S., and an important step toward addressing the diverse medical needs that exist for women with uterine fibroids,” said Brian O’Callaghan, CEO of ObsEva. “Our positive Phase 3 PRIMROSE results underscore linzagolix’s clinical utility and well-known differentiated profile. If approved, linzagolix will be the first oral GnRH antagonist to offer treatment options for women who cannot or do not want to take hormones, as well as for women who are able to take additional hormone therapy. We look forward to overcoming existing challenges in the treatment of uterine fibroids -- with linzagolix’s unique low-dose option (100 mg without ABT) and high dose option (200 mg with ABT) -- and will work with the FDA through the regulatory process as we prepare for commercialization.”</p>\n<p>Concurrently, ObsEva is also working closely with the European Medicine Agency’s (EMA) to achieve marketing approval. Linzagolix previously received validation of the marketing authorization application (MAA) with an approval recommendation from the Committee for Medicinal Products for Human Use (CHMP) expected in Q4 2021.</p>\n<p><b>About Linzagolix</b>Linzagolix is a novel, once daily, oral GnRH receptor antagonist with a potentially best-in-class profile. Linzagolix is currently in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis. ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product. Linzagolix is not currently approved anywhere in the world.</p>\n<p><b>About the Phase 3 PRIMROSE Program in Uterine Fibroids</b>PRIMROSE 1 &amp; 2 were prospective, randomized, parallel group, double-blind, placebo-controlled Phase 3 studies that investigated the efficacy and safety of two dosing regimens of linzagolix, 100 mg and 200 mg once daily, alone and in combination with hormonal ABT (1 mg estradiol and 0.5 mg norethisterone acetate) for the treatment of heavy menstrual bleeding associated with uterine fibroids. PRIMROSE 1 was conducted in the United States and enrolled 574 women. PRIMROSE 2 was conducted in Europe and the United States and enrolled 535 women. Both trials comprised a 52-week treatment period followed by a 6-month post treatment follow-up period.</p>\n<p><b>About Uterine Fibroids</b>Uterine fibroids are common benign tumors of the muscular tissue of the uterus. Uterine fibroids affect women of childbearing age and can vary in size from undetectable to large bulky masses. Few long-term medical treatments are available, and as a result, approximately 300,000 hysterectomies are performed for uterine fibroids every year in the US.</p>\n<p>The symptoms of uterine fibroids are wide-ranging and include heavy menstrual bleeding, anemia, pelvic pressure and bloating, urinary frequency and pain that can be extremely debilitating with a significant impact on quality of life. These symptoms can also have an impact on mental health, creating the additional burden of anxiety and distress.</p>\n<p><b>About ObsEva</b>ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on new therapies for the treatment of uterine fibroids, endometriosis, and preterm labor. ObsEva is listed on the Nasdaq Global Select Market and is traded under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is traded under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.</p>","source":"highlight_streetinsider","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>ObsEva Announces Submission of New Drug Application to U.S. FDA for Linzagolix for the Treatment of Uterine Fibroids</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\">\nObsEva Announces Submission of New Drug Application to U.S. FDA for Linzagolix for the Treatment of Uterine Fibroids\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-09-15 13:00 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.streetinsider.com/dr/news.php?id=18940734><strong>StreetInsider</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>-If approved, linzagolix will be the only GnRH antagonist with flexible dose regimen options to address the clinical needs of more women with uterine fibroids-\n-NDA submission includes positive data ...</p>\n\n<a href=\"https://www.streetinsider.com/dr/news.php?id=18940734\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{},"source_url":"https://www.streetinsider.com/dr/news.php?id=18940734","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"2167569486","content_text":"-If approved, linzagolix will be the only GnRH antagonist with flexible dose regimen options to address the clinical needs of more women with uterine fibroids-\n-NDA submission includes positive data from Phase 3 PRIMROSE trials up to 52 weeks on treatment and 24 weeks post-treatment follow-up results-\n-EU MAA CHMP recommendation anticipated in Q4 2021-\nAd hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange\nGENEVA, Switzerland– September 15, 2021 – ObsEva SA (NASDAQ: OBSV) (SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for linzagolix for the treatment of uterine fibroids. Linzagolix is an oral GnRH receptor antagonist with potential best-in-class efficacy, favorable tolerability profile, and unique and flexible dosing options. Further, if approved, linzagolix will be the only GnRH antagonist in uterine fibroids with a low dose non-add-back therapy (ABT) option.\nThe NDA submission includes the positive 52-week on treatment results from the Phase 3 PRIMROSE 1 (US only; n=574) and PRIMROSE 2 (Europe and US; n=535) clinical studies as well as supportive results from the 76-week post-treatment follow-up study. In both studies, patients with heavy menstrual bleeding (HMB) associated with uterine fibroids were administered linzagolix doses of 100 mg or 200 mg, with and without hormonal add-back-therapy (ABT; 1 mg estradiol/0.5 mg norethindrone acetate), or placebo. PRIMROSE 1 and 2 successfully met their primary endpoints, with all doses showing statistically significant and clinically relevant reductions in HMB compared to placebo.\n“The NDA submission is a major milestone in making linzagolix available in the U.S., and an important step toward addressing the diverse medical needs that exist for women with uterine fibroids,” said Brian O’Callaghan, CEO of ObsEva. “Our positive Phase 3 PRIMROSE results underscore linzagolix’s clinical utility and well-known differentiated profile. If approved, linzagolix will be the first oral GnRH antagonist to offer treatment options for women who cannot or do not want to take hormones, as well as for women who are able to take additional hormone therapy. We look forward to overcoming existing challenges in the treatment of uterine fibroids -- with linzagolix’s unique low-dose option (100 mg without ABT) and high dose option (200 mg with ABT) -- and will work with the FDA through the regulatory process as we prepare for commercialization.”\nConcurrently, ObsEva is also working closely with the European Medicine Agency’s (EMA) to achieve marketing approval. Linzagolix previously received validation of the marketing authorization application (MAA) with an approval recommendation from the Committee for Medicinal Products for Human Use (CHMP) expected in Q4 2021.\nAbout LinzagolixLinzagolix is a novel, once daily, oral GnRH receptor antagonist with a potentially best-in-class profile. Linzagolix is currently in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis. ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product. Linzagolix is not currently approved anywhere in the world.\nAbout the Phase 3 PRIMROSE Program in Uterine FibroidsPRIMROSE 1 & 2 were prospective, randomized, parallel group, double-blind, placebo-controlled Phase 3 studies that investigated the efficacy and safety of two dosing regimens of linzagolix, 100 mg and 200 mg once daily, alone and in combination with hormonal ABT (1 mg estradiol and 0.5 mg norethisterone acetate) for the treatment of heavy menstrual bleeding associated with uterine fibroids. PRIMROSE 1 was conducted in the United States and enrolled 574 women. PRIMROSE 2 was conducted in Europe and the United States and enrolled 535 women. Both trials comprised a 52-week treatment period followed by a 6-month post treatment follow-up period.\nAbout Uterine FibroidsUterine fibroids are common benign tumors of the muscular tissue of the uterus. Uterine fibroids affect women of childbearing age and can vary in size from undetectable to large bulky masses. Few long-term medical treatments are available, and as a result, approximately 300,000 hysterectomies are performed for uterine fibroids every year in the US.\nThe symptoms of uterine fibroids are wide-ranging and include heavy menstrual bleeding, anemia, pelvic pressure and bloating, urinary frequency and pain that can be extremely debilitating with a significant impact on quality of life. These symptoms can also have an impact on mental health, creating the additional burden of anxiety and distress.\nAbout ObsEvaObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on new therapies for the treatment of uterine fibroids, endometriosis, and preterm labor. ObsEva is listed on the Nasdaq Global Select Market and is traded under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is traded under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.","news_type":1},"isVote":1,"tweetType":1,"viewCount":481,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":882662501,"gmtCreate":1631686582003,"gmtModify":1676530608836,"author":{"id":"3582912128309068","authorId":"3582912128309068","name":"naux","avatar":"https://static.laohu8.com/default-avatar.jpg","crmLevel":7,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3582912128309068","authorIdStr":"3582912128309068"},"themes":[],"htmlText":"Ok","listText":"Ok","text":"Ok","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":7,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/882662501","repostId":"1148341685","repostType":4,"repost":{"id":"1148341685","pubTimestamp":1631660884,"share":"https://ttm.financial/m/news/1148341685?lang=&edition=fundamental","pubTime":"2021-09-15 07:08","market":"us","language":"en","title":"U.S. stocks close lower on worries over recovery, corporate tax hikes","url":"https://stock-news.laohu8.com/highlight/detail?id=1148341685","media":"Reuters","summary":"NEW YORK (Reuters) - Wall Street lost ground on Tuesday as economic uncertainties and the increasing","content":"<p>NEW YORK (Reuters) - Wall Street lost ground on Tuesday as economic uncertainties and the increasing likelihood of a corporate tax rate hike dampened investor sentiment and prompted a broad sell-off despite signs of easing inflation.</p>\n<p>Optimism faded throughout the session, reversing an initial rally following the Labor Department’s consumer price index report. All three major U.S. stock indexes ended in negative territory in a reminder that September is a historically rough month for stocks.</p>\n<p>So far this month the S&amp;P 500 is down nearly 1.8% even as the benchmark index has gained over 18% since the beginning of the year.</p>\n<p>“There is a possibility that the market is simply ready to go through an overdue correction,” said Sam Stovall, chief investment strategist at CFRA Research in New York. “From a seasonality perspective, September tends to be the window dressing period for fund managers.”</p>\n<p>The advent of the highly contagious Delta COVID variant has driven an increase in bearish sentiment regarding the recovery from the global health crisis, and many now expect a substantial correction in stock markets by the end of the year.</p>\n<p>“We’re still in a corrective mode that people have been calling for months,” said Paul Nolte, portfolio manager at Kingsview Asset Management in Chicago. “Economic data points have been missing estimates, and that has coincided with the rise in the Delta variant.”</p>\n<p>The CPI report delivered a lower-than-consensus August reading, a deceleration that supports Federal Reserve Chairman Jerome Powell’s assertion that spiking inflation is transitory and calms market fears that the central bank will begin tightening monetary policy sooner than expected.</p>\n<p>U.S. Treasury yields dropped on the data, which pressured financial stocks, and investor favor pivoted back to growth at the expense of value. [US/]</p>\n<p>The long expected corporate tax hikes, to 26.5% from 21% if Democrats prevail, are coming nearer to fruition with U.S. President Joe Biden’s $3.5 trillion budget package inching closer to passage.</p>\n<p>The Dow Jones Industrial Average fell 292.06 points, or 0.84%, to 34,577.57; the S&amp;P 500 lost 25.68 points, or 0.57%, at 4,443.05; and the Nasdaq Composite dropped 67.82 points, or 0.45%, to 15,037.76.</p>\n<p>All 11 major sectors in the S&amp;P 500 ended the session red, with energy and financials suffering the largest percentage drops.</p>\n<p>Apple Inc unveiled its iPhone 13 and added new features to its iPad and Apple Watch gadgets in its biggest product launch event of the year as the company faces increased scrutiny in the courts over its business practices. Its shares closed down 1.0% and were the heaviest drag on the S&amp;P 500 and the Nasdaq.</p>\n<p>Intuit Inc gained 1.9% following the TurboTax maker’s announcement that it would acquire digital marketing company Mailchimp for $12 billion.</p>\n<p>CureVac slid 8.0% after the German biotechnology company canceled manufacturing deals for its experimental COVID-19 vaccine.</p>\n<p>Declining issues outnumbered advancing ones on the NYSE by a 2.25-to-1 ratio; on Nasdaq, a 2.40-to-1 ratio favored decliners.</p>\n<p>The S&amp;P 500 posted two new 52-week highs and two new lows; the Nasdaq Composite recorded 50 new highs and 107 new lows.</p>\n<p>Volume on U.S. exchanges was 10.07 billion shares, compared with the 9.38 billion average over the last 20 trading days.</p>","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>U.S. stocks close lower on worries over recovery, corporate tax hikes</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\">\nU.S. stocks close lower on worries over recovery, corporate tax hikes\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-09-15 07:08 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.reuters.com/article/usa-stocks/u-s-stocks-close-lower-on-worries-over-recovery-corporate-tax-hikes-idUSKBN2GA0W9><strong>Reuters</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>NEW YORK (Reuters) - Wall Street lost ground on Tuesday as economic uncertainties and the increasing likelihood of a corporate tax rate hike dampened investor sentiment and prompted a broad sell-off ...</p>\n\n<a href=\"https://www.reuters.com/article/usa-stocks/u-s-stocks-close-lower-on-worries-over-recovery-corporate-tax-hikes-idUSKBN2GA0W9\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{".SPX":"S&P 500 Index",".DJI":"道琼斯",".IXIC":"NASDAQ Composite"},"source_url":"https://www.reuters.com/article/usa-stocks/u-s-stocks-close-lower-on-worries-over-recovery-corporate-tax-hikes-idUSKBN2GA0W9","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1148341685","content_text":"NEW YORK (Reuters) - Wall Street lost ground on Tuesday as economic uncertainties and the increasing likelihood of a corporate tax rate hike dampened investor sentiment and prompted a broad sell-off despite signs of easing inflation.\nOptimism faded throughout the session, reversing an initial rally following the Labor Department’s consumer price index report. All three major U.S. stock indexes ended in negative territory in a reminder that September is a historically rough month for stocks.\nSo far this month the S&P 500 is down nearly 1.8% even as the benchmark index has gained over 18% since the beginning of the year.\n“There is a possibility that the market is simply ready to go through an overdue correction,” said Sam Stovall, chief investment strategist at CFRA Research in New York. “From a seasonality perspective, September tends to be the window dressing period for fund managers.”\nThe advent of the highly contagious Delta COVID variant has driven an increase in bearish sentiment regarding the recovery from the global health crisis, and many now expect a substantial correction in stock markets by the end of the year.\n“We’re still in a corrective mode that people have been calling for months,” said Paul Nolte, portfolio manager at Kingsview Asset Management in Chicago. “Economic data points have been missing estimates, and that has coincided with the rise in the Delta variant.”\nThe CPI report delivered a lower-than-consensus August reading, a deceleration that supports Federal Reserve Chairman Jerome Powell’s assertion that spiking inflation is transitory and calms market fears that the central bank will begin tightening monetary policy sooner than expected.\nU.S. Treasury yields dropped on the data, which pressured financial stocks, and investor favor pivoted back to growth at the expense of value. [US/]\nThe long expected corporate tax hikes, to 26.5% from 21% if Democrats prevail, are coming nearer to fruition with U.S. President Joe Biden’s $3.5 trillion budget package inching closer to passage.\nThe Dow Jones Industrial Average fell 292.06 points, or 0.84%, to 34,577.57; the S&P 500 lost 25.68 points, or 0.57%, at 4,443.05; and the Nasdaq Composite dropped 67.82 points, or 0.45%, to 15,037.76.\nAll 11 major sectors in the S&P 500 ended the session red, with energy and financials suffering the largest percentage drops.\nApple Inc unveiled its iPhone 13 and added new features to its iPad and Apple Watch gadgets in its biggest product launch event of the year as the company faces increased scrutiny in the courts over its business practices. Its shares closed down 1.0% and were the heaviest drag on the S&P 500 and the Nasdaq.\nIntuit Inc gained 1.9% following the TurboTax maker’s announcement that it would acquire digital marketing company Mailchimp for $12 billion.\nCureVac slid 8.0% after the German biotechnology company canceled manufacturing deals for its experimental COVID-19 vaccine.\nDeclining issues outnumbered advancing ones on the NYSE by a 2.25-to-1 ratio; on Nasdaq, a 2.40-to-1 ratio favored decliners.\nThe S&P 500 posted two new 52-week highs and two new lows; the Nasdaq Composite recorded 50 new highs and 107 new lows.\nVolume on U.S. exchanges was 10.07 billion shares, compared with the 9.38 billion average over the last 20 trading days.","news_type":1},"isVote":1,"tweetType":1,"viewCount":248,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":101168312,"gmtCreate":1619863159736,"gmtModify":1704335859250,"author":{"id":"3582912128309068","authorId":"3582912128309068","name":"naux","avatar":"https://static.laohu8.com/default-avatar.jpg","crmLevel":7,"crmLevelSwitch":0,"followedFlag":false,"idStr":"3582912128309068","authorIdStr":"3582912128309068"},"themes":[],"htmlText":"Nice","listText":"Nice","text":"Nice","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":2,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/101168312","repostId":"1142070002","repostType":4,"repost":{"id":"1142070002","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1619792975,"share":"https://ttm.financial/m/news/1142070002?lang=&edition=fundamental","pubTime":"2021-04-30 22:29","market":"us","language":"en","title":"NIO rose more than 5%, after falling nearly 4% before","url":"https://stock-news.laohu8.com/highlight/detail?id=1142070002","media":"Tiger Newspress","summary":"NIO Earnings Looked a Lot Like Ford’s. What to Know.Chinese electric vehicle maker NIO posted better than expected first quarter results. But the global automotive microchip shortage will hit production in the coming months.NIO  is a highly valued, high-growth stock. Now NIO bulls have to decide whether solid earnings will trump the growth hiccup or whether the chip shortage can hurt the company in the long run.NIO lost 23 cents a share on an adjusted, non-GAAP basis, from $1.2 billion in sales.","content":"<p>NIO rose more than 5%, after falling nearly 4% before.</p><p><img src=\"https://static.tigerbbs.com/80881ae9e6de48ac5e3733583db3ba9e\" tg-width=\"840\" tg-height=\"470\" referrerpolicy=\"no-referrer\"></p><p><b>NIO Earnings Looked a Lot Like Ford’s. What to Know.</b></p><p>Chinese electric vehicle maker NIO posted better than expected first quarter results. But the global automotive microchip shortage will hit production in the coming months.</p><p>NIO (ticker: NIO) is a highly valued, high-growth stock. Now NIO bulls have to decide whether solid earnings will trump the growth hiccup or whether the chip shortage can hurt the company in the long run.</p><p>NIO lost&nbsp;23 cents&nbsp;a share on an adjusted, non-GAAP basis, from $1.2 billion in sales. Wall Street was looking for a comparable 84 cent loss from $1.1 billion in sales. NIO’s corporate gross profit margin came in at 19.5%, about 3 percentage points better than analysts projected and up from negative 12% a year ago. First quarter results look solid.</p><p>The stock isn’t moving though. NIO reported numbers at 5:30 p.m. eastern time and not a lot of stock is trading after hours. NIO shares closed down 5.3% in Thursday trading. TheS&amp;P 500&nbsp;and&nbsp;Dow Jones Industrial Average&nbsp;rose about&nbsp; 0.7%.</p><p>“NIO started the year of 2021 with a new quarterly delivery record of 20,060 vehicles in the first quarter,” said CEO William Bin Li in the company’s news release. “The overall demand for our products continues to be quite strong, but the supply chain is still facing significant challenges due to the semiconductor shortage.”</p><p>Management called the chip situation “very severe” on its conference call and projected 21,000 to 22,000 vehicle deliveries for the second quarter and sales of about $1.3 billion. The Street is projecting $1.2 billion in sales. But the unit delivery guidance is a little lower than Deutsche Bank analyst Edison Yu had expected.</p><p>For the full year, Yu is modeling 95,000 deliveries. With about 42,000 deliveries likely for the first half of 2021, the resolution of the global chip shortage will go a long way to deciding whether or not NIO can reach Yu’s number.</p><p>Yu rates NIO shares Buy and has a $60 price target for the stock.</p><p>The overall quarter feels a little like&nbsp;Ford Motor‘s (F) quarter, which was&nbsp;reported Wednesday. Ford reported sales and earnings far better than Wall Street projected. Unit volumes were below the company’s internal projections, but improving vehicle mix boosted sales beyond Street projections. Ford prioritized making higher-end vehicles in the face of limited chip supply. Looking ahead, Ford said the impact of the chip shortage would be at the high end of the company’s initial $1 billion to $2.5 billion cost guidance.</p><p>Ford stock close down 9.4% Thursday, the day after the Wednesday evening report. The NIO second-quarter guidance isn’t as surprising as Ford’s. And NIO doesn’t have full-year guidance. But calling NIO’s stock price reaction is difficult.</p><p>Ford trades for less than 7 times estimated 2022 earnings. NIO is expected to become profitable on a full-year basis in 2022. What’s more, NIO is worth about 50% more than Ford.</p><p>NIO’s conference call wrapped up about 10 p.m. eastern time. After the chip shortage, analysts focused questions on EV competition in China and NIO’s production expansion. NIO is putting in place&nbsp;capacity to produce&nbsp;hundreds of thousands of vehicles in coming years.</p>","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>NIO rose more than 5%, after falling nearly 4% before</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\">\nNIO rose more than 5%, after falling nearly 4% before\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time\">2021-04-30 22:29</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>NIO rose more than 5%, after falling nearly 4% before.</p><p><img src=\"https://static.tigerbbs.com/80881ae9e6de48ac5e3733583db3ba9e\" tg-width=\"840\" tg-height=\"470\" referrerpolicy=\"no-referrer\"></p><p><b>NIO Earnings Looked a Lot Like Ford’s. What to Know.</b></p><p>Chinese electric vehicle maker NIO posted better than expected first quarter results. But the global automotive microchip shortage will hit production in the coming months.</p><p>NIO (ticker: NIO) is a highly valued, high-growth stock. Now NIO bulls have to decide whether solid earnings will trump the growth hiccup or whether the chip shortage can hurt the company in the long run.</p><p>NIO lost&nbsp;23 cents&nbsp;a share on an adjusted, non-GAAP basis, from $1.2 billion in sales. Wall Street was looking for a comparable 84 cent loss from $1.1 billion in sales. NIO’s corporate gross profit margin came in at 19.5%, about 3 percentage points better than analysts projected and up from negative 12% a year ago. First quarter results look solid.</p><p>The stock isn’t moving though. NIO reported numbers at 5:30 p.m. eastern time and not a lot of stock is trading after hours. NIO shares closed down 5.3% in Thursday trading. TheS&amp;P 500&nbsp;and&nbsp;Dow Jones Industrial Average&nbsp;rose about&nbsp; 0.7%.</p><p>“NIO started the year of 2021 with a new quarterly delivery record of 20,060 vehicles in the first quarter,” said CEO William Bin Li in the company’s news release. “The overall demand for our products continues to be quite strong, but the supply chain is still facing significant challenges due to the semiconductor shortage.”</p><p>Management called the chip situation “very severe” on its conference call and projected 21,000 to 22,000 vehicle deliveries for the second quarter and sales of about $1.3 billion. The Street is projecting $1.2 billion in sales. But the unit delivery guidance is a little lower than Deutsche Bank analyst Edison Yu had expected.</p><p>For the full year, Yu is modeling 95,000 deliveries. With about 42,000 deliveries likely for the first half of 2021, the resolution of the global chip shortage will go a long way to deciding whether or not NIO can reach Yu’s number.</p><p>Yu rates NIO shares Buy and has a $60 price target for the stock.</p><p>The overall quarter feels a little like&nbsp;Ford Motor‘s (F) quarter, which was&nbsp;reported Wednesday. Ford reported sales and earnings far better than Wall Street projected. Unit volumes were below the company’s internal projections, but improving vehicle mix boosted sales beyond Street projections. Ford prioritized making higher-end vehicles in the face of limited chip supply. Looking ahead, Ford said the impact of the chip shortage would be at the high end of the company’s initial $1 billion to $2.5 billion cost guidance.</p><p>Ford stock close down 9.4% Thursday, the day after the Wednesday evening report. The NIO second-quarter guidance isn’t as surprising as Ford’s. And NIO doesn’t have full-year guidance. But calling NIO’s stock price reaction is difficult.</p><p>Ford trades for less than 7 times estimated 2022 earnings. NIO is expected to become profitable on a full-year basis in 2022. What’s more, NIO is worth about 50% more than Ford.</p><p>NIO’s conference call wrapped up about 10 p.m. eastern time. After the chip shortage, analysts focused questions on EV competition in China and NIO’s production expansion. NIO is putting in place&nbsp;capacity to produce&nbsp;hundreds of thousands of vehicles in coming years.</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"NIO":"蔚来"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1142070002","content_text":"NIO rose more than 5%, after falling nearly 4% before.NIO Earnings Looked a Lot Like Ford’s. What to Know.Chinese electric vehicle maker NIO posted better than expected first quarter results. But the global automotive microchip shortage will hit production in the coming months.NIO (ticker: NIO) is a highly valued, high-growth stock. Now NIO bulls have to decide whether solid earnings will trump the growth hiccup or whether the chip shortage can hurt the company in the long run.NIO lost 23 cents a share on an adjusted, non-GAAP basis, from $1.2 billion in sales. Wall Street was looking for a comparable 84 cent loss from $1.1 billion in sales. NIO’s corporate gross profit margin came in at 19.5%, about 3 percentage points better than analysts projected and up from negative 12% a year ago. First quarter results look solid.The stock isn’t moving though. NIO reported numbers at 5:30 p.m. eastern time and not a lot of stock is trading after hours. NIO shares closed down 5.3% in Thursday trading. TheS&P 500 and Dow Jones Industrial Average rose about  0.7%.“NIO started the year of 2021 with a new quarterly delivery record of 20,060 vehicles in the first quarter,” said CEO William Bin Li in the company’s news release. “The overall demand for our products continues to be quite strong, but the supply chain is still facing significant challenges due to the semiconductor shortage.”Management called the chip situation “very severe” on its conference call and projected 21,000 to 22,000 vehicle deliveries for the second quarter and sales of about $1.3 billion. The Street is projecting $1.2 billion in sales. But the unit delivery guidance is a little lower than Deutsche Bank analyst Edison Yu had expected.For the full year, Yu is modeling 95,000 deliveries. With about 42,000 deliveries likely for the first half of 2021, the resolution of the global chip shortage will go a long way to deciding whether or not NIO can reach Yu’s number.Yu rates NIO shares Buy and has a $60 price target for the stock.The overall quarter feels a little like Ford Motor‘s (F) quarter, which was reported Wednesday. Ford reported sales and earnings far better than Wall Street projected. Unit volumes were below the company’s internal projections, but improving vehicle mix boosted sales beyond Street projections. Ford prioritized making higher-end vehicles in the face of limited chip supply. Looking ahead, Ford said the impact of the chip shortage would be at the high end of the company’s initial $1 billion to $2.5 billion cost guidance.Ford stock close down 9.4% Thursday, the day after the Wednesday evening report. The NIO second-quarter guidance isn’t as surprising as Ford’s. And NIO doesn’t have full-year guidance. But calling NIO’s stock price reaction is difficult.Ford trades for less than 7 times estimated 2022 earnings. NIO is expected to become profitable on a full-year basis in 2022. What’s more, NIO is worth about 50% more than Ford.NIO’s conference call wrapped up about 10 p.m. eastern time. After the chip shortage, analysts focused questions on EV competition in China and NIO’s production expansion. NIO is putting in place capacity to produce hundreds of thousands of vehicles in coming years.","news_type":1},"isVote":1,"tweetType":1,"viewCount":387,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0}],"hots":[{"id":882662501,"gmtCreate":1631686582003,"gmtModify":1676530608836,"author":{"id":"3582912128309068","authorId":"3582912128309068","name":"naux","avatar":"https://static.laohu8.com/default-avatar.jpg","crmLevel":7,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3582912128309068","idStr":"3582912128309068"},"themes":[],"htmlText":"Ok","listText":"Ok","text":"Ok","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":7,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/882662501","repostId":"1148341685","repostType":4,"repost":{"id":"1148341685","pubTimestamp":1631660884,"share":"https://ttm.financial/m/news/1148341685?lang=&edition=fundamental","pubTime":"2021-09-15 07:08","market":"us","language":"en","title":"U.S. stocks close lower on worries over recovery, corporate tax hikes","url":"https://stock-news.laohu8.com/highlight/detail?id=1148341685","media":"Reuters","summary":"NEW YORK (Reuters) - Wall Street lost ground on Tuesday as economic uncertainties and the increasing","content":"<p>NEW YORK (Reuters) - Wall Street lost ground on Tuesday as economic uncertainties and the increasing likelihood of a corporate tax rate hike dampened investor sentiment and prompted a broad sell-off despite signs of easing inflation.</p>\n<p>Optimism faded throughout the session, reversing an initial rally following the Labor Department’s consumer price index report. All three major U.S. stock indexes ended in negative territory in a reminder that September is a historically rough month for stocks.</p>\n<p>So far this month the S&amp;P 500 is down nearly 1.8% even as the benchmark index has gained over 18% since the beginning of the year.</p>\n<p>“There is a possibility that the market is simply ready to go through an overdue correction,” said Sam Stovall, chief investment strategist at CFRA Research in New York. “From a seasonality perspective, September tends to be the window dressing period for fund managers.”</p>\n<p>The advent of the highly contagious Delta COVID variant has driven an increase in bearish sentiment regarding the recovery from the global health crisis, and many now expect a substantial correction in stock markets by the end of the year.</p>\n<p>“We’re still in a corrective mode that people have been calling for months,” said Paul Nolte, portfolio manager at Kingsview Asset Management in Chicago. “Economic data points have been missing estimates, and that has coincided with the rise in the Delta variant.”</p>\n<p>The CPI report delivered a lower-than-consensus August reading, a deceleration that supports Federal Reserve Chairman Jerome Powell’s assertion that spiking inflation is transitory and calms market fears that the central bank will begin tightening monetary policy sooner than expected.</p>\n<p>U.S. Treasury yields dropped on the data, which pressured financial stocks, and investor favor pivoted back to growth at the expense of value. [US/]</p>\n<p>The long expected corporate tax hikes, to 26.5% from 21% if Democrats prevail, are coming nearer to fruition with U.S. President Joe Biden’s $3.5 trillion budget package inching closer to passage.</p>\n<p>The Dow Jones Industrial Average fell 292.06 points, or 0.84%, to 34,577.57; the S&amp;P 500 lost 25.68 points, or 0.57%, at 4,443.05; and the Nasdaq Composite dropped 67.82 points, or 0.45%, to 15,037.76.</p>\n<p>All 11 major sectors in the S&amp;P 500 ended the session red, with energy and financials suffering the largest percentage drops.</p>\n<p>Apple Inc unveiled its iPhone 13 and added new features to its iPad and Apple Watch gadgets in its biggest product launch event of the year as the company faces increased scrutiny in the courts over its business practices. Its shares closed down 1.0% and were the heaviest drag on the S&amp;P 500 and the Nasdaq.</p>\n<p>Intuit Inc gained 1.9% following the TurboTax maker’s announcement that it would acquire digital marketing company Mailchimp for $12 billion.</p>\n<p>CureVac slid 8.0% after the German biotechnology company canceled manufacturing deals for its experimental COVID-19 vaccine.</p>\n<p>Declining issues outnumbered advancing ones on the NYSE by a 2.25-to-1 ratio; on Nasdaq, a 2.40-to-1 ratio favored decliners.</p>\n<p>The S&amp;P 500 posted two new 52-week highs and two new lows; the Nasdaq Composite recorded 50 new highs and 107 new lows.</p>\n<p>Volume on U.S. exchanges was 10.07 billion shares, compared with the 9.38 billion average over the last 20 trading days.</p>","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>U.S. stocks close lower on worries over recovery, corporate tax hikes</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\">\nU.S. stocks close lower on worries over recovery, corporate tax hikes\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-09-15 07:08 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.reuters.com/article/usa-stocks/u-s-stocks-close-lower-on-worries-over-recovery-corporate-tax-hikes-idUSKBN2GA0W9><strong>Reuters</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>NEW YORK (Reuters) - Wall Street lost ground on Tuesday as economic uncertainties and the increasing likelihood of a corporate tax rate hike dampened investor sentiment and prompted a broad sell-off ...</p>\n\n<a href=\"https://www.reuters.com/article/usa-stocks/u-s-stocks-close-lower-on-worries-over-recovery-corporate-tax-hikes-idUSKBN2GA0W9\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{".SPX":"S&P 500 Index",".DJI":"道琼斯",".IXIC":"NASDAQ Composite"},"source_url":"https://www.reuters.com/article/usa-stocks/u-s-stocks-close-lower-on-worries-over-recovery-corporate-tax-hikes-idUSKBN2GA0W9","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1148341685","content_text":"NEW YORK (Reuters) - Wall Street lost ground on Tuesday as economic uncertainties and the increasing likelihood of a corporate tax rate hike dampened investor sentiment and prompted a broad sell-off despite signs of easing inflation.\nOptimism faded throughout the session, reversing an initial rally following the Labor Department’s consumer price index report. All three major U.S. stock indexes ended in negative territory in a reminder that September is a historically rough month for stocks.\nSo far this month the S&P 500 is down nearly 1.8% even as the benchmark index has gained over 18% since the beginning of the year.\n“There is a possibility that the market is simply ready to go through an overdue correction,” said Sam Stovall, chief investment strategist at CFRA Research in New York. “From a seasonality perspective, September tends to be the window dressing period for fund managers.”\nThe advent of the highly contagious Delta COVID variant has driven an increase in bearish sentiment regarding the recovery from the global health crisis, and many now expect a substantial correction in stock markets by the end of the year.\n“We’re still in a corrective mode that people have been calling for months,” said Paul Nolte, portfolio manager at Kingsview Asset Management in Chicago. “Economic data points have been missing estimates, and that has coincided with the rise in the Delta variant.”\nThe CPI report delivered a lower-than-consensus August reading, a deceleration that supports Federal Reserve Chairman Jerome Powell’s assertion that spiking inflation is transitory and calms market fears that the central bank will begin tightening monetary policy sooner than expected.\nU.S. Treasury yields dropped on the data, which pressured financial stocks, and investor favor pivoted back to growth at the expense of value. [US/]\nThe long expected corporate tax hikes, to 26.5% from 21% if Democrats prevail, are coming nearer to fruition with U.S. President Joe Biden’s $3.5 trillion budget package inching closer to passage.\nThe Dow Jones Industrial Average fell 292.06 points, or 0.84%, to 34,577.57; the S&P 500 lost 25.68 points, or 0.57%, at 4,443.05; and the Nasdaq Composite dropped 67.82 points, or 0.45%, to 15,037.76.\nAll 11 major sectors in the S&P 500 ended the session red, with energy and financials suffering the largest percentage drops.\nApple Inc unveiled its iPhone 13 and added new features to its iPad and Apple Watch gadgets in its biggest product launch event of the year as the company faces increased scrutiny in the courts over its business practices. Its shares closed down 1.0% and were the heaviest drag on the S&P 500 and the Nasdaq.\nIntuit Inc gained 1.9% following the TurboTax maker’s announcement that it would acquire digital marketing company Mailchimp for $12 billion.\nCureVac slid 8.0% after the German biotechnology company canceled manufacturing deals for its experimental COVID-19 vaccine.\nDeclining issues outnumbered advancing ones on the NYSE by a 2.25-to-1 ratio; on Nasdaq, a 2.40-to-1 ratio favored decliners.\nThe S&P 500 posted two new 52-week highs and two new lows; the Nasdaq Composite recorded 50 new highs and 107 new lows.\nVolume on U.S. exchanges was 10.07 billion shares, compared with the 9.38 billion average over the last 20 trading days.","news_type":1},"isVote":1,"tweetType":1,"viewCount":248,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":101168312,"gmtCreate":1619863159736,"gmtModify":1704335859250,"author":{"id":"3582912128309068","authorId":"3582912128309068","name":"naux","avatar":"https://static.laohu8.com/default-avatar.jpg","crmLevel":7,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3582912128309068","idStr":"3582912128309068"},"themes":[],"htmlText":"Nice","listText":"Nice","text":"Nice","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":2,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/101168312","repostId":"1142070002","repostType":4,"repost":{"id":"1142070002","weMediaInfo":{"introduction":"Providing stock market headlines, business news, financials and earnings ","home_visible":1,"media_name":"Tiger Newspress","id":"1079075236","head_image":"https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba"},"pubTimestamp":1619792975,"share":"https://ttm.financial/m/news/1142070002?lang=&edition=fundamental","pubTime":"2021-04-30 22:29","market":"us","language":"en","title":"NIO rose more than 5%, after falling nearly 4% before","url":"https://stock-news.laohu8.com/highlight/detail?id=1142070002","media":"Tiger Newspress","summary":"NIO Earnings Looked a Lot Like Ford’s. What to Know.Chinese electric vehicle maker NIO posted better than expected first quarter results. But the global automotive microchip shortage will hit production in the coming months.NIO  is a highly valued, high-growth stock. Now NIO bulls have to decide whether solid earnings will trump the growth hiccup or whether the chip shortage can hurt the company in the long run.NIO lost 23 cents a share on an adjusted, non-GAAP basis, from $1.2 billion in sales.","content":"<p>NIO rose more than 5%, after falling nearly 4% before.</p><p><img src=\"https://static.tigerbbs.com/80881ae9e6de48ac5e3733583db3ba9e\" tg-width=\"840\" tg-height=\"470\" referrerpolicy=\"no-referrer\"></p><p><b>NIO Earnings Looked a Lot Like Ford’s. What to Know.</b></p><p>Chinese electric vehicle maker NIO posted better than expected first quarter results. But the global automotive microchip shortage will hit production in the coming months.</p><p>NIO (ticker: NIO) is a highly valued, high-growth stock. Now NIO bulls have to decide whether solid earnings will trump the growth hiccup or whether the chip shortage can hurt the company in the long run.</p><p>NIO lost&nbsp;23 cents&nbsp;a share on an adjusted, non-GAAP basis, from $1.2 billion in sales. Wall Street was looking for a comparable 84 cent loss from $1.1 billion in sales. NIO’s corporate gross profit margin came in at 19.5%, about 3 percentage points better than analysts projected and up from negative 12% a year ago. First quarter results look solid.</p><p>The stock isn’t moving though. NIO reported numbers at 5:30 p.m. eastern time and not a lot of stock is trading after hours. NIO shares closed down 5.3% in Thursday trading. TheS&amp;P 500&nbsp;and&nbsp;Dow Jones Industrial Average&nbsp;rose about&nbsp; 0.7%.</p><p>“NIO started the year of 2021 with a new quarterly delivery record of 20,060 vehicles in the first quarter,” said CEO William Bin Li in the company’s news release. “The overall demand for our products continues to be quite strong, but the supply chain is still facing significant challenges due to the semiconductor shortage.”</p><p>Management called the chip situation “very severe” on its conference call and projected 21,000 to 22,000 vehicle deliveries for the second quarter and sales of about $1.3 billion. The Street is projecting $1.2 billion in sales. But the unit delivery guidance is a little lower than Deutsche Bank analyst Edison Yu had expected.</p><p>For the full year, Yu is modeling 95,000 deliveries. With about 42,000 deliveries likely for the first half of 2021, the resolution of the global chip shortage will go a long way to deciding whether or not NIO can reach Yu’s number.</p><p>Yu rates NIO shares Buy and has a $60 price target for the stock.</p><p>The overall quarter feels a little like&nbsp;Ford Motor‘s (F) quarter, which was&nbsp;reported Wednesday. Ford reported sales and earnings far better than Wall Street projected. Unit volumes were below the company’s internal projections, but improving vehicle mix boosted sales beyond Street projections. Ford prioritized making higher-end vehicles in the face of limited chip supply. Looking ahead, Ford said the impact of the chip shortage would be at the high end of the company’s initial $1 billion to $2.5 billion cost guidance.</p><p>Ford stock close down 9.4% Thursday, the day after the Wednesday evening report. The NIO second-quarter guidance isn’t as surprising as Ford’s. And NIO doesn’t have full-year guidance. But calling NIO’s stock price reaction is difficult.</p><p>Ford trades for less than 7 times estimated 2022 earnings. NIO is expected to become profitable on a full-year basis in 2022. What’s more, NIO is worth about 50% more than Ford.</p><p>NIO’s conference call wrapped up about 10 p.m. eastern time. After the chip shortage, analysts focused questions on EV competition in China and NIO’s production expansion. NIO is putting in place&nbsp;capacity to produce&nbsp;hundreds of thousands of vehicles in coming years.</p>","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>NIO rose more than 5%, after falling nearly 4% before</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\">\nNIO rose more than 5%, after falling nearly 4% before\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Tiger Newspress </p>\n<p class=\"h-time\">2021-04-30 22:29</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<p>NIO rose more than 5%, after falling nearly 4% before.</p><p><img src=\"https://static.tigerbbs.com/80881ae9e6de48ac5e3733583db3ba9e\" tg-width=\"840\" tg-height=\"470\" referrerpolicy=\"no-referrer\"></p><p><b>NIO Earnings Looked a Lot Like Ford’s. What to Know.</b></p><p>Chinese electric vehicle maker NIO posted better than expected first quarter results. But the global automotive microchip shortage will hit production in the coming months.</p><p>NIO (ticker: NIO) is a highly valued, high-growth stock. Now NIO bulls have to decide whether solid earnings will trump the growth hiccup or whether the chip shortage can hurt the company in the long run.</p><p>NIO lost&nbsp;23 cents&nbsp;a share on an adjusted, non-GAAP basis, from $1.2 billion in sales. Wall Street was looking for a comparable 84 cent loss from $1.1 billion in sales. NIO’s corporate gross profit margin came in at 19.5%, about 3 percentage points better than analysts projected and up from negative 12% a year ago. First quarter results look solid.</p><p>The stock isn’t moving though. NIO reported numbers at 5:30 p.m. eastern time and not a lot of stock is trading after hours. NIO shares closed down 5.3% in Thursday trading. TheS&amp;P 500&nbsp;and&nbsp;Dow Jones Industrial Average&nbsp;rose about&nbsp; 0.7%.</p><p>“NIO started the year of 2021 with a new quarterly delivery record of 20,060 vehicles in the first quarter,” said CEO William Bin Li in the company’s news release. “The overall demand for our products continues to be quite strong, but the supply chain is still facing significant challenges due to the semiconductor shortage.”</p><p>Management called the chip situation “very severe” on its conference call and projected 21,000 to 22,000 vehicle deliveries for the second quarter and sales of about $1.3 billion. The Street is projecting $1.2 billion in sales. But the unit delivery guidance is a little lower than Deutsche Bank analyst Edison Yu had expected.</p><p>For the full year, Yu is modeling 95,000 deliveries. With about 42,000 deliveries likely for the first half of 2021, the resolution of the global chip shortage will go a long way to deciding whether or not NIO can reach Yu’s number.</p><p>Yu rates NIO shares Buy and has a $60 price target for the stock.</p><p>The overall quarter feels a little like&nbsp;Ford Motor‘s (F) quarter, which was&nbsp;reported Wednesday. Ford reported sales and earnings far better than Wall Street projected. Unit volumes were below the company’s internal projections, but improving vehicle mix boosted sales beyond Street projections. Ford prioritized making higher-end vehicles in the face of limited chip supply. Looking ahead, Ford said the impact of the chip shortage would be at the high end of the company’s initial $1 billion to $2.5 billion cost guidance.</p><p>Ford stock close down 9.4% Thursday, the day after the Wednesday evening report. The NIO second-quarter guidance isn’t as surprising as Ford’s. And NIO doesn’t have full-year guidance. But calling NIO’s stock price reaction is difficult.</p><p>Ford trades for less than 7 times estimated 2022 earnings. NIO is expected to become profitable on a full-year basis in 2022. What’s more, NIO is worth about 50% more than Ford.</p><p>NIO’s conference call wrapped up about 10 p.m. eastern time. After the chip shortage, analysts focused questions on EV competition in China and NIO’s production expansion. NIO is putting in place&nbsp;capacity to produce&nbsp;hundreds of thousands of vehicles in coming years.</p>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"NIO":"蔚来"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1142070002","content_text":"NIO rose more than 5%, after falling nearly 4% before.NIO Earnings Looked a Lot Like Ford’s. What to Know.Chinese electric vehicle maker NIO posted better than expected first quarter results. But the global automotive microchip shortage will hit production in the coming months.NIO (ticker: NIO) is a highly valued, high-growth stock. Now NIO bulls have to decide whether solid earnings will trump the growth hiccup or whether the chip shortage can hurt the company in the long run.NIO lost 23 cents a share on an adjusted, non-GAAP basis, from $1.2 billion in sales. Wall Street was looking for a comparable 84 cent loss from $1.1 billion in sales. NIO’s corporate gross profit margin came in at 19.5%, about 3 percentage points better than analysts projected and up from negative 12% a year ago. First quarter results look solid.The stock isn’t moving though. NIO reported numbers at 5:30 p.m. eastern time and not a lot of stock is trading after hours. NIO shares closed down 5.3% in Thursday trading. TheS&P 500 and Dow Jones Industrial Average rose about  0.7%.“NIO started the year of 2021 with a new quarterly delivery record of 20,060 vehicles in the first quarter,” said CEO William Bin Li in the company’s news release. “The overall demand for our products continues to be quite strong, but the supply chain is still facing significant challenges due to the semiconductor shortage.”Management called the chip situation “very severe” on its conference call and projected 21,000 to 22,000 vehicle deliveries for the second quarter and sales of about $1.3 billion. The Street is projecting $1.2 billion in sales. But the unit delivery guidance is a little lower than Deutsche Bank analyst Edison Yu had expected.For the full year, Yu is modeling 95,000 deliveries. With about 42,000 deliveries likely for the first half of 2021, the resolution of the global chip shortage will go a long way to deciding whether or not NIO can reach Yu’s number.Yu rates NIO shares Buy and has a $60 price target for the stock.The overall quarter feels a little like Ford Motor‘s (F) quarter, which was reported Wednesday. Ford reported sales and earnings far better than Wall Street projected. Unit volumes were below the company’s internal projections, but improving vehicle mix boosted sales beyond Street projections. Ford prioritized making higher-end vehicles in the face of limited chip supply. Looking ahead, Ford said the impact of the chip shortage would be at the high end of the company’s initial $1 billion to $2.5 billion cost guidance.Ford stock close down 9.4% Thursday, the day after the Wednesday evening report. The NIO second-quarter guidance isn’t as surprising as Ford’s. And NIO doesn’t have full-year guidance. But calling NIO’s stock price reaction is difficult.Ford trades for less than 7 times estimated 2022 earnings. NIO is expected to become profitable on a full-year basis in 2022. What’s more, NIO is worth about 50% more than Ford.NIO’s conference call wrapped up about 10 p.m. eastern time. After the chip shortage, analysts focused questions on EV competition in China and NIO’s production expansion. NIO is putting in place capacity to produce hundreds of thousands of vehicles in coming years.","news_type":1},"isVote":1,"tweetType":1,"viewCount":387,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0},{"id":882665186,"gmtCreate":1631686616045,"gmtModify":1676530608860,"author":{"id":"3582912128309068","authorId":"3582912128309068","name":"naux","avatar":"https://static.laohu8.com/default-avatar.jpg","crmLevel":7,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"3582912128309068","idStr":"3582912128309068"},"themes":[],"htmlText":"Ok","listText":"Ok","text":"Ok","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/882665186","repostId":"2167569486","repostType":4,"repost":{"id":"2167569486","pubTimestamp":1631682000,"share":"https://ttm.financial/m/news/2167569486?lang=&edition=fundamental","pubTime":"2021-09-15 13:00","market":"us","language":"en","title":"ObsEva Announces Submission of New Drug Application to U.S. FDA for Linzagolix for the Treatment of Uterine Fibroids","url":"https://stock-news.laohu8.com/highlight/detail?id=2167569486","media":"StreetInsider","summary":"-If approved, linzagolix will be the only GnRH antagonist with flexible dose regimen options to addr","content":"<p><i>-If approved, linzagolix will be the only GnRH antagonist with flexible dose regimen</i> <i>options to address the clinical needs of more women with uterine fibroids-</i></p>\n<p><i>-NDA submission</i> <i>includes positive data from Phase 3 PRIMROSE trials</i> <i>up to 52 weeks on treatment and 24 weeks post-treatment follow-up results-</i></p>\n<p><i>-EU MAA CHMP recommendation anticipated in Q4 2021-</i></p>\n<p>Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange</p>\n<p><b>GENEVA, Switzerland– September 15, 2021 </b>– ObsEva SA (NASDAQ: OBSV) (SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for linzagolix for the treatment of uterine fibroids. Linzagolix is an oral GnRH receptor antagonist with potential best-in-class efficacy, favorable tolerability profile, and unique and flexible dosing options. Further, if approved, linzagolix will be the only GnRH antagonist in uterine fibroids with a low dose non-add-back therapy (ABT) option.</p>\n<p>The NDA submission includes the positive 52-week on treatment results from the Phase 3 PRIMROSE 1 (US only; n=574) and PRIMROSE 2 (Europe and US; n=535) clinical studies as well as supportive results from the 76-week post-treatment follow-up study. In both studies, patients with heavy menstrual bleeding (HMB) associated with uterine fibroids were administered linzagolix doses of 100 mg or 200 mg, with and without hormonal add-back-therapy (ABT; 1 mg estradiol/0.5 mg norethindrone acetate), or placebo. PRIMROSE 1 and 2 successfully met their primary endpoints, with all doses showing statistically significant and clinically relevant reductions in HMB compared to placebo.</p>\n<p>“The NDA submission is a major milestone in making linzagolix available in the U.S., and an important step toward addressing the diverse medical needs that exist for women with uterine fibroids,” said Brian O’Callaghan, CEO of ObsEva. “Our positive Phase 3 PRIMROSE results underscore linzagolix’s clinical utility and well-known differentiated profile. If approved, linzagolix will be the first oral GnRH antagonist to offer treatment options for women who cannot or do not want to take hormones, as well as for women who are able to take additional hormone therapy. We look forward to overcoming existing challenges in the treatment of uterine fibroids -- with linzagolix’s unique low-dose option (100 mg without ABT) and high dose option (200 mg with ABT) -- and will work with the FDA through the regulatory process as we prepare for commercialization.”</p>\n<p>Concurrently, ObsEva is also working closely with the European Medicine Agency’s (EMA) to achieve marketing approval. Linzagolix previously received validation of the marketing authorization application (MAA) with an approval recommendation from the Committee for Medicinal Products for Human Use (CHMP) expected in Q4 2021.</p>\n<p><b>About Linzagolix</b>Linzagolix is a novel, once daily, oral GnRH receptor antagonist with a potentially best-in-class profile. Linzagolix is currently in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis. ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product. Linzagolix is not currently approved anywhere in the world.</p>\n<p><b>About the Phase 3 PRIMROSE Program in Uterine Fibroids</b>PRIMROSE 1 &amp; 2 were prospective, randomized, parallel group, double-blind, placebo-controlled Phase 3 studies that investigated the efficacy and safety of two dosing regimens of linzagolix, 100 mg and 200 mg once daily, alone and in combination with hormonal ABT (1 mg estradiol and 0.5 mg norethisterone acetate) for the treatment of heavy menstrual bleeding associated with uterine fibroids. PRIMROSE 1 was conducted in the United States and enrolled 574 women. PRIMROSE 2 was conducted in Europe and the United States and enrolled 535 women. Both trials comprised a 52-week treatment period followed by a 6-month post treatment follow-up period.</p>\n<p><b>About Uterine Fibroids</b>Uterine fibroids are common benign tumors of the muscular tissue of the uterus. Uterine fibroids affect women of childbearing age and can vary in size from undetectable to large bulky masses. Few long-term medical treatments are available, and as a result, approximately 300,000 hysterectomies are performed for uterine fibroids every year in the US.</p>\n<p>The symptoms of uterine fibroids are wide-ranging and include heavy menstrual bleeding, anemia, pelvic pressure and bloating, urinary frequency and pain that can be extremely debilitating with a significant impact on quality of life. These symptoms can also have an impact on mental health, creating the additional burden of anxiety and distress.</p>\n<p><b>About ObsEva</b>ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on new therapies for the treatment of uterine fibroids, endometriosis, and preterm labor. ObsEva is listed on the Nasdaq Global Select Market and is traded under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is traded under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.</p>","source":"highlight_streetinsider","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>ObsEva Announces Submission of New Drug Application to U.S. FDA for Linzagolix for the Treatment of Uterine Fibroids</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\">\nObsEva Announces Submission of New Drug Application to U.S. FDA for Linzagolix for the Treatment of Uterine Fibroids\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-09-15 13:00 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.streetinsider.com/dr/news.php?id=18940734><strong>StreetInsider</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>-If approved, linzagolix will be the only GnRH antagonist with flexible dose regimen options to address the clinical needs of more women with uterine fibroids-\n-NDA submission includes positive data ...</p>\n\n<a href=\"https://www.streetinsider.com/dr/news.php?id=18940734\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{},"source_url":"https://www.streetinsider.com/dr/news.php?id=18940734","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"2167569486","content_text":"-If approved, linzagolix will be the only GnRH antagonist with flexible dose regimen options to address the clinical needs of more women with uterine fibroids-\n-NDA submission includes positive data from Phase 3 PRIMROSE trials up to 52 weeks on treatment and 24 weeks post-treatment follow-up results-\n-EU MAA CHMP recommendation anticipated in Q4 2021-\nAd hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange\nGENEVA, Switzerland– September 15, 2021 – ObsEva SA (NASDAQ: OBSV) (SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for linzagolix for the treatment of uterine fibroids. Linzagolix is an oral GnRH receptor antagonist with potential best-in-class efficacy, favorable tolerability profile, and unique and flexible dosing options. Further, if approved, linzagolix will be the only GnRH antagonist in uterine fibroids with a low dose non-add-back therapy (ABT) option.\nThe NDA submission includes the positive 52-week on treatment results from the Phase 3 PRIMROSE 1 (US only; n=574) and PRIMROSE 2 (Europe and US; n=535) clinical studies as well as supportive results from the 76-week post-treatment follow-up study. In both studies, patients with heavy menstrual bleeding (HMB) associated with uterine fibroids were administered linzagolix doses of 100 mg or 200 mg, with and without hormonal add-back-therapy (ABT; 1 mg estradiol/0.5 mg norethindrone acetate), or placebo. PRIMROSE 1 and 2 successfully met their primary endpoints, with all doses showing statistically significant and clinically relevant reductions in HMB compared to placebo.\n“The NDA submission is a major milestone in making linzagolix available in the U.S., and an important step toward addressing the diverse medical needs that exist for women with uterine fibroids,” said Brian O’Callaghan, CEO of ObsEva. “Our positive Phase 3 PRIMROSE results underscore linzagolix’s clinical utility and well-known differentiated profile. If approved, linzagolix will be the first oral GnRH antagonist to offer treatment options for women who cannot or do not want to take hormones, as well as for women who are able to take additional hormone therapy. We look forward to overcoming existing challenges in the treatment of uterine fibroids -- with linzagolix’s unique low-dose option (100 mg without ABT) and high dose option (200 mg with ABT) -- and will work with the FDA through the regulatory process as we prepare for commercialization.”\nConcurrently, ObsEva is also working closely with the European Medicine Agency’s (EMA) to achieve marketing approval. Linzagolix previously received validation of the marketing authorization application (MAA) with an approval recommendation from the Committee for Medicinal Products for Human Use (CHMP) expected in Q4 2021.\nAbout LinzagolixLinzagolix is a novel, once daily, oral GnRH receptor antagonist with a potentially best-in-class profile. Linzagolix is currently in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis. ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product. Linzagolix is not currently approved anywhere in the world.\nAbout the Phase 3 PRIMROSE Program in Uterine FibroidsPRIMROSE 1 & 2 were prospective, randomized, parallel group, double-blind, placebo-controlled Phase 3 studies that investigated the efficacy and safety of two dosing regimens of linzagolix, 100 mg and 200 mg once daily, alone and in combination with hormonal ABT (1 mg estradiol and 0.5 mg norethisterone acetate) for the treatment of heavy menstrual bleeding associated with uterine fibroids. PRIMROSE 1 was conducted in the United States and enrolled 574 women. PRIMROSE 2 was conducted in Europe and the United States and enrolled 535 women. Both trials comprised a 52-week treatment period followed by a 6-month post treatment follow-up period.\nAbout Uterine FibroidsUterine fibroids are common benign tumors of the muscular tissue of the uterus. Uterine fibroids affect women of childbearing age and can vary in size from undetectable to large bulky masses. Few long-term medical treatments are available, and as a result, approximately 300,000 hysterectomies are performed for uterine fibroids every year in the US.\nThe symptoms of uterine fibroids are wide-ranging and include heavy menstrual bleeding, anemia, pelvic pressure and bloating, urinary frequency and pain that can be extremely debilitating with a significant impact on quality of life. These symptoms can also have an impact on mental health, creating the additional burden of anxiety and distress.\nAbout ObsEvaObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on new therapies for the treatment of uterine fibroids, endometriosis, and preterm labor. ObsEva is listed on the Nasdaq Global Select Market and is traded under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is traded under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.","news_type":1},"isVote":1,"tweetType":1,"viewCount":481,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0}],"lives":[]}