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The Week Ahead In Biotech (Dec.26-Jan. 1): Xeris FDA Decision, Pending Clinical Readouts In Focus In Final Week Of Year<blockquote>生物技术未来一周（12 月 26 日至 1 月 1 日）：Xeris FDA 决定，今年最后一周的临床数据成为焦点</blockquote>

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Market Quotes, Business News, Financial News, Trading Ideas, and Stock Research by Professionals","home_visible":0,"media_name":"Benzinga","id":"1052270027","head_image":"https://static.tigerbbs.com/d08bf7808052c0ca9deb4e944cae32aa"},"pubTimestamp":1640586449,"share":"https://www.laohu8.com/m/news/1105609028?lang=zh_CN&edition=full","pubTime":"2021-12-27 14:27","market":"us","language":"en","title":"The Week Ahead In Biotech (Dec.26-Jan. 1): Xeris FDA Decision, Pending Clinical Readouts In Focus In Final Week Of Year<blockquote>生物技术未来一周（12 月 26 日至 1 月 1 日）：Xeris FDA 决定，今年最后一周的临床数据成为焦点</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1105609028","media":"Benzinga","summary":"Biopharma stocks eked out modest gains in the week ending Dec. 23, with regulatory decisions, clinic","content":"Biopharma stocks eked out modest gains in the week ending&nbsp;Dec. 23, with regulatory decisions, clinical readouts and COVID-19 treatment and vaccine developments&nbsp;dictating sentiment.<blockquote>截至 12 月的一周，生物制药股小幅上涨。23，监管决策、临床数据以及 COVID-19 治疗和疫苗开发决定了市场情绪。</blockquote> The week's news was headlined by the Food and Drug Administration issuing emergency use authorizations for two oral COVID-19 antiviral pills.&nbsp;Pfizer, Inc.received authorization for its oral drug Paxlovid on Wednesday, followed by&nbsp;Merck &amp; Co., Inc.'s&nbsp;molnupiravir.<blockquote>本周新闻的头条新闻是美国食品和药物管理局颁发了两种口服新冠肺炎抗病毒药丸的紧急使用授权。辉瑞公司。周三获得其口服药物Paxlovid的授权，随后默克公司莫努匹拉韦。</blockquote> BiondVax Pharmaceuticals Ltd.rallied strongly after it announced in-licensing of nano-sized COVID-19 antibody.<blockquote>BiondVax制药有限公司在宣布获得纳米级 COVID-19 抗体许可后，股价强劲反弹。</blockquote> Allakos Inc.&nbsp;was among the worst performers of the week after the company's investigational compound&nbsp;flunkedlate-stage studies in inflammation of the digestive tract.<blockquote>阿拉科斯公司。在该公司的研究化合物在消化道炎症方面的后期研究失败后，是本周表现最差的公司之一。</blockquote> Here are the key biopharma catalysts for the unfolding week:<blockquote>以下是本周的主要生物制药催化剂：</blockquote> PDUFA Dates<blockquote>PDUFA日期</blockquote> The FDA is scheduled to announce its verdict on&nbsp;Xeris Biopharma Holdings, Inc.'s&nbsp;new drug application for Recorlev (levoketoconazole), an investigational adrenal steroidogenesis inhibitor in development for the treatment of patients with endogenous Cushing's syndrome.<blockquote>FDA 计划宣布其裁决Xeris 生物制药控股公司Recorlev（左酮康唑）的新药申请，这是一种正在开发中的研究性肾上腺类固醇生成抑制剂，用于治疗内源性库欣综合征患者。</blockquote> Clinical Readouts/Presentations<blockquote>临床读数/演示</blockquote> Year-end Releases<blockquote>年终发布</blockquote> Anavex Life Sciences Corp.: Top-line results from the second placebo-controlled AVATAR Phase 2/3 study of Anavex2-73 for the treatment of adult patients with Rett syndrome and top-line results from the placebo-controlled Phase 1 ANAVEX 3-71-001 study evaluating ANAVEX3-71 in humans<blockquote>Anavex生命科学公司。Anavex2-73用于治疗Rett综合征成人患者的第二项安慰剂对照AVATAR 2/3期研究的顶线结果和Anavex3-71-001人体评价的安慰剂对照1期研究的顶线结果</blockquote> Vanda Pharmaceuticals Inc.: results of Phase 3 study off tradipitant in gastroparesis<blockquote>万达制药公司。tradipitant治疗胃轻瘫的3期研究结果</blockquote> Second-Half Data Releases<blockquote>下半年数据发布</blockquote> Adagene Inc.: Results from ongoing dose escalation of ADG126 monotherapy in solid tumors<blockquote>阿达根公司。实体瘤中ADG126单药治疗持续剂量递增的结果</blockquote> Fourth-quarter Releases<blockquote>第四季度发布</blockquote> Corbus Pharmaceuticals Holdings, Inc.: topline data from the National Institutes of Health-sponsored Phase 2 study of lenabasum in systemic lupus erythematosus<blockquote>科布斯制药控股公司。：美国国立卫生研究院赞助的lenabasum治疗系统性红斑狼疮的2期研究的主要数据</blockquote> Vir Biotechnology, Inc.: initial VIR-111, its HIV vaccine candidate, immunology data<blockquote>维尔生物技术公司。：初始VIR-111，其HIV候选疫苗，免疫学数据</blockquote> Avalo Therapeutics, Inc.: opline Phase 1b data for AVTX-002 in moderate to severe Crohn's disease patients expected<blockquote>阿瓦洛治疗公司。：AVTX-002在中度至重度克罗恩病患者中的离线1b期数据</blockquote> December Releases<blockquote>12月发布</blockquote> Taysha Gene Therapies, Inc.: clinical safety and MFM32 functional data for TSHA-120 from the highest dose cohort of 3.5x1014 total vg in giant axonal neuropathy and preliminary clinical safety data and Hex A enzyme activity in the plasma and cerebral spinal fluid for TSHA-101 in GM2 gangliosidosis<blockquote>泰莎基因治疗公司。：来自3.5x1014总vg最高剂量队列的TSHA-120在巨大轴突神经病中的临床安全性和MFM32功能数据，以及GM2神经节苷脂沉积症中TSHA-101在血浆和脑脊液中的初步临床安全性数据和Hex A酶活性</blockquote> 2021/Late-2021 Releases<blockquote>2021/2021年末发布</blockquote> BridgeBio Pharma, Inc.: topline results from Part A of the Phase 3 ATTRibute-CM trial of Acoramidis for transthyretin amyloid cardiomyopathy (late-2021)<blockquote>布里奇生物制药公司。：Acoramidis治疗甲状腺素转运蛋白淀粉样心肌病的3期ATTRibute-CM试验A部分的顶线结果（2021年末）</blockquote>","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\" 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}\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: 12.5px; color: #7E829C; margin: 0;}\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\">\nThe Week Ahead In Biotech (Dec.26-Jan. 1): Xeris FDA Decision, Pending Clinical Readouts In Focus In Final Week Of Year<blockquote>生物技术未来一周（12 月 26 日至 1 月 1 日）：Xeris FDA 决定，今年最后一周的临床数据成为焦点</blockquote>\n</h2>\n<h4 class=\"meta\">\n<div class=\"head\" \">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/d08bf7808052c0ca9deb4e944cae32aa);background-size:cover;\"></div>\n\n<div class=\"h-content\">\nBenzinga \n2021-12-27 14:27\n</div>\n</div>\n</h4>\n</header>\n<article>\nBiopharma stocks eked out modest gains in the week ending&nbsp;Dec. 23, with regulatory decisions, clinical readouts and COVID-19 treatment and vaccine developments&nbsp;dictating sentiment.<blockquote>截至 12 月的一周，生物制药股小幅上涨。23，监管决策、临床数据以及 COVID-19 治疗和疫苗开发决定了市场情绪。</blockquote> The week's news was headlined by the Food and Drug Administration issuing emergency use authorizations for two oral COVID-19 antiviral pills.&nbsp;Pfizer, Inc.received authorization for its oral drug Paxlovid on Wednesday, followed by&nbsp;Merck &amp; Co., Inc.'s&nbsp;molnupiravir.<blockquote>本周新闻的头条新闻是美国食品和药物管理局颁发了两种口服新冠肺炎抗病毒药丸的紧急使用授权。辉瑞公司。周三获得其口服药物Paxlovid的授权，随后默克公司莫努匹拉韦。</blockquote> BiondVax Pharmaceuticals Ltd.rallied strongly after it announced in-licensing of nano-sized COVID-19 antibody.<blockquote>BiondVax制药有限公司在宣布获得纳米级 COVID-19 抗体许可后，股价强劲反弹。</blockquote> Allakos Inc.&nbsp;was among the worst performers of the week after the company's investigational compound&nbsp;flunkedlate-stage studies in inflammation of the digestive tract.<blockquote>阿拉科斯公司。在该公司的研究化合物在消化道炎症方面的后期研究失败后，是本周表现最差的公司之一。</blockquote> Here are the key biopharma catalysts for the unfolding week:<blockquote>以下是本周的主要生物制药催化剂：</blockquote> PDUFA Dates<blockquote>PDUFA日期</blockquote> The FDA is scheduled to announce its verdict on&nbsp;Xeris Biopharma Holdings, Inc.'s&nbsp;new drug application for Recorlev (levoketoconazole), an investigational adrenal steroidogenesis inhibitor in development for the treatment of patients with endogenous Cushing's syndrome.<blockquote>FDA 计划宣布其裁决Xeris 生物制药控股公司Recorlev（左酮康唑）的新药申请，这是一种正在开发中的研究性肾上腺类固醇生成抑制剂，用于治疗内源性库欣综合征患者。</blockquote> Clinical Readouts/Presentations<blockquote>临床读数/演示</blockquote> Year-end Releases<blockquote>年终发布</blockquote> Anavex Life Sciences Corp.: Top-line results from the second placebo-controlled AVATAR Phase 2/3 study of Anavex2-73 for the treatment of adult patients with Rett syndrome and top-line results from the placebo-controlled Phase 1 ANAVEX 3-71-001 study evaluating ANAVEX3-71 in humans<blockquote>Anavex生命科学公司。Anavex2-73用于治疗Rett综合征成人患者的第二项安慰剂对照AVATAR 2/3期研究的顶线结果和Anavex3-71-001人体评价的安慰剂对照1期研究的顶线结果</blockquote> Vanda Pharmaceuticals Inc.: results of Phase 3 study off tradipitant in gastroparesis<blockquote>万达制药公司。tradipitant治疗胃轻瘫的3期研究结果</blockquote> Second-Half Data Releases<blockquote>下半年数据发布</blockquote> Adagene Inc.: Results from ongoing dose escalation of ADG126 monotherapy in solid tumors<blockquote>阿达根公司。实体瘤中ADG126单药治疗持续剂量递增的结果</blockquote> Fourth-quarter Releases<blockquote>第四季度发布</blockquote> Corbus Pharmaceuticals Holdings, Inc.: topline data from the National Institutes of Health-sponsored Phase 2 study of lenabasum in systemic lupus erythematosus<blockquote>科布斯制药控股公司。：美国国立卫生研究院赞助的lenabasum治疗系统性红斑狼疮的2期研究的主要数据</blockquote> Vir Biotechnology, Inc.: initial VIR-111, its HIV vaccine candidate, immunology data<blockquote>维尔生物技术公司。：初始VIR-111，其HIV候选疫苗，免疫学数据</blockquote> Avalo Therapeutics, Inc.: opline Phase 1b data for AVTX-002 in moderate to severe Crohn's disease patients expected<blockquote>阿瓦洛治疗公司。：AVTX-002在中度至重度克罗恩病患者中的离线1b期数据</blockquote> December Releases<blockquote>12月发布</blockquote> Taysha Gene Therapies, Inc.: clinical safety and MFM32 functional data for TSHA-120 from the highest dose cohort of 3.5x1014 total vg in giant axonal neuropathy and preliminary clinical safety data and Hex A enzyme activity in the plasma and cerebral spinal fluid for TSHA-101 in GM2 gangliosidosis<blockquote>泰莎基因治疗公司。：来自3.5x1014总vg最高剂量队列的TSHA-120在巨大轴突神经病中的临床安全性和MFM32功能数据，以及GM2神经节苷脂沉积症中TSHA-101在血浆和脑脊液中的初步临床安全性数据和Hex A酶活性</blockquote> 2021/Late-2021 Releases<blockquote>2021/2021年末发布</blockquote> BridgeBio Pharma, Inc.: topline results from Part A of the Phase 3 ATTRibute-CM trial of Acoramidis for transthyretin amyloid cardiomyopathy (late-2021)<blockquote>布里奇生物制药公司。：Acoramidis治疗甲状腺素转运蛋白淀粉样心肌病的3期ATTRibute-CM试验A部分的顶线结果（2021年末）</blockquote>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"CRBP":"Corbus Pharmaceuticals Holdings, Inc.","VIR":"Vir Biotechnology, Inc.","XERS":"Xeris制药","ADAG":"天演药业","VNDA":"万达生物制药","BBIO":"BridgeBio Pharma, Inc.","AVTX":"Avalo Therapeutics Inc","TSHA":"Taysha Gene Therapies, Inc.","AVXL":"Anavex Life Sciences Corp."},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1105609028","content_text":"Biopharma stocks eked out modest gains in the week ending Dec. 23, with regulatory decisions, clinical readouts and COVID-19 treatment and vaccine developments dictating sentiment.\nThe week's news was headlined by the Food and Drug Administration issuing emergency use authorizations for two oral COVID-19 antiviral pills. Pfizer, Inc.received authorization for its oral drug Paxlovid on Wednesday, followed by Merck & Co., Inc.'s molnupiravir.\nBiondVax Pharmaceuticals Ltd.rallied strongly after it announced in-licensing of nano-sized COVID-19 antibody.\nAllakos Inc. was among the worst performers of the week after the company's investigational compound flunkedlate-stage studies in inflammation of the digestive tract.\nHere are the key biopharma catalysts for the unfolding week:\nPDUFA Dates\nThe FDA is scheduled to announce its verdict on Xeris Biopharma Holdings, Inc.'s new drug application for Recorlev (levoketoconazole), an investigational adrenal steroidogenesis inhibitor in development for the treatment of patients with endogenous Cushing's syndrome.\nClinical Readouts/Presentations\nYear-end Releases\nAnavex Life Sciences Corp.: Top-line results from the second placebo-controlled AVATAR Phase 2/3 study of Anavex2-73 for the treatment of adult patients with Rett syndrome and top-line results from the placebo-controlled Phase 1 ANAVEX 3-71-001 study evaluating ANAVEX3-71 in humans\nVanda Pharmaceuticals Inc.: results of Phase 3 study off tradipitant in gastroparesis\nSecond-Half Data Releases\nAdagene Inc.: Results from ongoing dose escalation of ADG126 monotherapy in solid tumors\nFourth-quarter Releases\nCorbus Pharmaceuticals Holdings, Inc.: topline data from the National Institutes of Health-sponsored Phase 2 study of lenabasum in systemic lupus erythematosus\nVir Biotechnology, Inc.: initial VIR-111, its HIV vaccine candidate, immunology data\nAvalo Therapeutics, Inc.: opline Phase 1b data for AVTX-002 in moderate to severe Crohn's disease patients expected\nDecember Releases\nTaysha Gene Therapies, Inc.: clinical safety and MFM32 functional data for TSHA-120 from the highest dose cohort of 3.5x1014 total vg in giant axonal neuropathy and preliminary clinical safety data and Hex A enzyme activity in the plasma and cerebral spinal fluid for TSHA-101 in GM2 gangliosidosis\n2021/Late-2021 Releases\nBridgeBio Pharma, Inc.: topline results from Part A of the Phase 3 ATTRibute-CM trial of Acoramidis for transthyretin amyloid cardiomyopathy (late-2021)","news_type":1,"symbols_score_info":{"VNDA":0.9,"CRBP":0.9,"TSHA":0.9,"XERS":0.9,"VIR":0.9,"ADAG":0.9,"AVXL":0.9,"AVTX":0.9,"BBIO":0.9}},"isVote":1,"tweetType":1,"viewCount":1365,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"CN","currentLanguage":"CN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":5,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/696904152"}