YTL
2021-06-16
[微笑]
The Daily Biotech Pulse: Nabriva Jumps On Data, Larimar Wilts After Study Put On Hold, Travere To Delay Regulatory Filing
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href=\"https://laohu8.com/S/EPIX\">ESSA Pharma Inc.</a> </strong>(NASDAQ:EPIX)</li>\n<li><strong><a href=\"https://laohu8.com/S/PIRS\">Pieris Pharmaceuticals, Inc.</a> </strong>(NASDAQ:PIRS) (moved on a R&D pact with <strong>Roche Holdings AG </strong>(OTC: RHHBY) in the field of respiratory and ophthalmology)</li>\n<li><strong><a href=\"https://laohu8.com/S/PLXP\">PLx Pharma Inc.</a> </strong>(NASDAQ:PLXP)</li>\n<li><strong><a href=\"https://laohu8.com/S/PRAH\">PRA Health Sciences</a>, Inc. </strong>(NASDAQ:PRAH)</li>\n<li><strong>ShockWave Medical, Inc. </strong>(NASDAQ:SWAV)</li>\n<li><strong><a href=\"https://laohu8.com/S/SYNH\">Syneos Health, Inc.</a> </strong>(NASDAQ:SYNH)</li>\n<li><strong>West Pharmaceutical Services, Inc. </strong>(NYSE:WST)</li>\n</ul>\n<h3>Down In The Dumps</h3>\n<p>(Biotech Stocks Hitting 52-week Lows May 25)</p>\n<ul>\n<li><strong>89bio, Inc. </strong>(NASDAQ:ETNB)</li>\n<li><strong>Allogene Therapeutics, Inc. </strong>(NASDAQ:ALLO)</li>\n<li><strong>Amicus Therapeutics, Inc. </strong>(NASDAQ:FOLD)</li>\n<li><strong><a href=\"https://laohu8.com/S/BCEL\">Atreca</a>, Inc. </strong>(NASDAQ:BCEL)</li>\n<li><strong><a href=\"https://laohu8.com/S/AXLA\">Axcella Health Inc.</a> </strong>(NASDAQ:AXLA)</li>\n<li><strong>Aytu Biopharma, Inc. </strong>(NASDAQ:AYTU)</li>\n<li><strong><a href=\"https://laohu8.com/S/BOLT\">Bolt Biotherapeutics, Inc.</a> </strong>(NASDAQ:BOLT)</li>\n<li><strong><a href=\"https://laohu8.com/S/CEMI\">Chembio Diagnostics</a>, Inc. </strong>(NASDAQ:CEMI)</li>\n<li><strong><a href=\"https://laohu8.com/S/CCXI\">ChemoCentryx</a>, Inc. </strong>(NASDAQ:CCXI)</li>\n<li><strong>Coherus BioSciences, Inc. </strong>(NASDAQ:CHRS)</li>\n<li><strong><a href=\"https://laohu8.com/S/IMPL\">Impel NeuroPharma, Inc.</a> </strong>(NASDAQ:IMPL)</li>\n<li><strong><a href=\"https://laohu8.com/S/ICPT\">Intercept Pharmaceuticals</a>, Inc. </strong>(NASDAQ:ICPT)</li>\n<li><strong><a href=\"https://laohu8.com/S/IONS\">Ionis Pharmaceuticals, Inc</a>. </strong>(NASDAQ:IONS)</li>\n<li><strong>Kiniksa Pharmaceuticals, Ltd. </strong>(NASDAQ:KNSA)</li>\n<li><strong><a href=\"https://laohu8.com/S/LYRA\">Lyra Therapeutics</a>, Inc. </strong>(NASDAQ:LYRA)</li>\n<li><strong><a href=\"https://laohu8.com/S/NYMX\">Nymox Pharmaceutical Corporation</a> </strong>(NASDAQ:NYMX)</li>\n<li><strong><a href=\"https://laohu8.com/S/SPRB\">Spruce Biosciences, Inc.</a> </strong>(NASDAQ:SPRB)</li>\n<li><strong><a href=\"https://laohu8.com/S/VVOS\">Vivos Therapeutics</a>, Inc. </strong>(NASDAQ:VVOS)</li>\n<li><strong><a href=\"https://laohu8.com/S/VKTXW\">Viking Therapeutics, Inc.</a> </strong>(NASDAQ:VKTX)</li>\n</ul>\n<h3>Stocks In Focus</h3>\n<h3>Nabriva's Antibiotic Aces a Late-stage Trial In China.</h3>\n<p><strong>Nabriva Therapeutics </strong>(NASDAQ:NBRV) and partner Sinovant Sciences announced positive topline results from Sinovant's Phase 3 bridging study of lefamulin in Chinese adults with community-acquired bacterial pneumonia.</p>\n<p>Lefamulin was shown to be non-inferior to moxifloxacin, with 76.8% of lefamulin-treated patients meeting the efficacy endpoint of Investigator Assessment of Clinical Response at Test of Cure, compared to 71.4% of patients treated with moxifloxacin.</p>\n<p>Consistent with previously reported clinical trial results, lefamulin was observed to be generally safe and well-tolerated, with an overall rate of treatment-emergent adverse events comparable to that of moxifloxacin.</p>\n<p>Sinovant also announced an agreement with Sumitomo Pharmaceuticals to acquire development and commercialization rights for lefamulin in Greater China.</p>\n<p>Nabriva's Lefamulin was approved to treat CABP in the U.S. in August 2019 and is marketed under the trade name Xenleta.</p>\n<p>Nabriva shares jumped 40.54% to $2.08 in after-hours trading.</p>\n<h3>Travere Will Not Pursue Accelerated Approval of Drug to Treat Kidney Scarring In Second Half of 2021</h3>\n<p><strong><a href=\"https://laohu8.com/S/TVTX\">Travere Therapeutics, Inc.</a> </strong>(NASDAQ:TVTX) said it received final pre-NDA meeting minutes, wherein the FDA acknowledged the high unmet need for approved therapies for the treatment of focal segmental glomerulosclerosis but indicated the available data from the interim assessment of the DUPLEX study evaluating its sparsentan for the indication would not be adequate to support an accelerated approval at this time.</p>\n<p>The company said it now no longer expects to submit for accelerated approval for FSGS in the U.S. during the second half of 2021.</p>\n<p>Subject to further discussion with the FDA, the company believes that it may be possible to provide sufficient additional estimated glomerular filtration data from in the first half of 2022. The FDA has encouraged the company to request a follow-up meeting to further explore this option in greater detail, and a Type A meeting is expected to occur in the third quarter of 2021.</p>\n<p>The stock slipped 8.45% to $16.25 in after-hours trading.</p>\n<h3>Larimar's Phase 1 Study of Friedreich's Ataxia Placed On Clinical Hold</h3>\n<p><strong><a href=\"https://laohu8.com/S/LRMR\">Larimar Therapeutics, Inc.</a> </strong>(NASDAQ:LRMR) said the FDA has placed its CTI-1601 clinical program on hold and that it will not be closing a previously announced private placement financing. CTI-1601 is a recombinant fusion protein intended to deliver human frataxin into the mitochondria of patients with Friedreich's ataxia, who are unable to produce enough of this essential protein.</p>\n<p>The clinical hold follows the previous notification by Larimar to the FDA of mortalities that occurred at the highest dose levels in an ongoing 180-day non-human primate toxicology study. CTI-1601 is currently in Phase 1 clinical trials in the U.S.,</p>\n<p>The stock plunged 45.23% to $7.40 in after-hours trading.</p>\n<h3>Qiagen, Mirati to Develop Companion Diagnostic For KRAS Mutant Cancers</h3>\n<p><strong>QIAGEN N.V. </strong>(NYSE:QGEN) and <strong><a href=\"https://laohu8.com/S/MRTX\">Mirati Therapeutics Inc.</a> </strong>(NASDAQ:MRTX) announced a global collaboration to continue developing a tissue-based KRAS companion diagnostic to identify patients with cancers that have a KRAS-G12C mutation who may benefit from treatment with adagrasib, Mirati's investigational oral small molecule inhibitor of KRAS-G12C.</p>\n<p>The agreement initially focuses on a companion diagnostic test for non-small cell lung cancer, and allows for further development of tests for other Mirati oncology programs.</p>\n<h3>NeoVasc Notified of Non-compliance With Nasdaq Listing Standards</h3>\n<p><strong>NeoVasc Inc </strong>(NASDAQ:NVCN) said it has received written notification from the Nasdaq that it is not in compliance with the minimum bid price requirement for continued listing on the Nasdaq.</p>\n<p>The company said it has been provided 180 calendar days, or until November 22, to regain compliance.</p>\n<p><em>Related Link: Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates </em></p>\n<h3>Altimmune's Intranasal COVID-19 Vaccine Found Effective Against South African Variants In Animal Study</h3>\n<p><strong><a href=\"https://laohu8.com/S/ALT\">Altimmune, Inc.</a> </strong>(NASDAQ:ALT) announced new results from a preclinical study demonstrating the ability of its AdCOVID vaccine candidate to neutralize the rapidly emerging SARS-CoV-2 B.1.351 variant of concern that originated in South Africa.</p>\n<p>B.1.351 carries multiple mutations in the receptor-binding domain including the E484K mutation that has been shown to substantially decrease the ability of authorized vaccines to neutralize the virus.</p>\n<p>The stock was up 6.61% at $12.68 in premarket trading Wednesday.</p>\n<h3>Selecta Gains On Insider Buying</h3>\n<p><strong>Selecta Biosciences, Inc. </strong>(NASDAQ:SELB) revealed in a filing that Timothy Springer, a director of the board, bought 2,773,479 shares of the company at $3.19 apiece. The stock gained 9.52% to $3.91 in after-hours trading.</p>\n<h3>Neuroone Announces Uplisting to Nasdaq</h3>\n<p><strong>NeuroOne Medical Technologies Corporation Common Stock </strong>(OTC:NMTC), a MedTech company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, said its shares have been approved to uplist to the Nasdaq. Trading of the shares on the Nasdaq is expected to begin effective Wednesday, under the Company's existing ticker symbol \"NMTC\".</p>\n<h3>On The Radar</h3>\n<h3>Clinical Readouts/Presentations</h3>\n<p><strong><a href=\"https://laohu8.com/S/CHMA\">Chiasma, Inc.</a> </strong>(NASDAQ:CHMA) is scheduled to virtually present at the American Association of Clinical Endocrinology 2021 Annual meeting encore new data from the MPOWERED Phase 3 study of Mycapssa in adults with acromegaly.</p>\n<h3>Earnings</h3>\n<p><strong><a href=\"https://laohu8.com/S/BLRX\">BioLineRx Ltd</a>. </strong>(NASDAQ:BLRX) (before the market open)</p>\n</body></html>","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>The Daily Biotech Pulse: Nabriva Jumps On Data, Larimar Wilts After Study Put On Hold, Travere To Delay Regulatory Filing</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{ 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class=\"h-content\">\n<p class=\"h-name\">Benzinga </p>\n<p class=\"h-time\">2021-05-26 19:33</p>\n</div>\n\n</div>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p>Here's a roundup of top developments in the biotech space over the last 24 hours.</p>\n<h3>Scaling The Peaks</h3>\n<p>(Biotech Stocks Hitting 52-week Highs May 25)</p>\n<ul>\n<li><strong><a href=\"https://laohu8.com/S/EPIX\">ESSA Pharma Inc.</a> </strong>(NASDAQ:EPIX)</li>\n<li><strong><a href=\"https://laohu8.com/S/PIRS\">Pieris Pharmaceuticals, Inc.</a> </strong>(NASDAQ:PIRS) (moved on a R&D pact with <strong>Roche Holdings AG </strong>(OTC: RHHBY) in the field of respiratory and ophthalmology)</li>\n<li><strong><a href=\"https://laohu8.com/S/PLXP\">PLx Pharma Inc.</a> </strong>(NASDAQ:PLXP)</li>\n<li><strong><a href=\"https://laohu8.com/S/PRAH\">PRA Health Sciences</a>, Inc. </strong>(NASDAQ:PRAH)</li>\n<li><strong>ShockWave Medical, Inc. </strong>(NASDAQ:SWAV)</li>\n<li><strong><a href=\"https://laohu8.com/S/SYNH\">Syneos Health, Inc.</a> </strong>(NASDAQ:SYNH)</li>\n<li><strong>West Pharmaceutical Services, Inc. </strong>(NYSE:WST)</li>\n</ul>\n<h3>Down In The Dumps</h3>\n<p>(Biotech Stocks Hitting 52-week Lows May 25)</p>\n<ul>\n<li><strong>89bio, Inc. </strong>(NASDAQ:ETNB)</li>\n<li><strong>Allogene Therapeutics, Inc. </strong>(NASDAQ:ALLO)</li>\n<li><strong>Amicus Therapeutics, Inc. </strong>(NASDAQ:FOLD)</li>\n<li><strong><a href=\"https://laohu8.com/S/BCEL\">Atreca</a>, Inc. </strong>(NASDAQ:BCEL)</li>\n<li><strong><a href=\"https://laohu8.com/S/AXLA\">Axcella Health Inc.</a> </strong>(NASDAQ:AXLA)</li>\n<li><strong>Aytu Biopharma, Inc. </strong>(NASDAQ:AYTU)</li>\n<li><strong><a href=\"https://laohu8.com/S/BOLT\">Bolt Biotherapeutics, Inc.</a> </strong>(NASDAQ:BOLT)</li>\n<li><strong><a href=\"https://laohu8.com/S/CEMI\">Chembio Diagnostics</a>, Inc. </strong>(NASDAQ:CEMI)</li>\n<li><strong><a href=\"https://laohu8.com/S/CCXI\">ChemoCentryx</a>, Inc. </strong>(NASDAQ:CCXI)</li>\n<li><strong>Coherus BioSciences, Inc. </strong>(NASDAQ:CHRS)</li>\n<li><strong><a href=\"https://laohu8.com/S/IMPL\">Impel NeuroPharma, Inc.</a> </strong>(NASDAQ:IMPL)</li>\n<li><strong><a href=\"https://laohu8.com/S/ICPT\">Intercept Pharmaceuticals</a>, Inc. </strong>(NASDAQ:ICPT)</li>\n<li><strong><a href=\"https://laohu8.com/S/IONS\">Ionis Pharmaceuticals, Inc</a>. </strong>(NASDAQ:IONS)</li>\n<li><strong>Kiniksa Pharmaceuticals, Ltd. </strong>(NASDAQ:KNSA)</li>\n<li><strong><a href=\"https://laohu8.com/S/LYRA\">Lyra Therapeutics</a>, Inc. </strong>(NASDAQ:LYRA)</li>\n<li><strong><a href=\"https://laohu8.com/S/NYMX\">Nymox Pharmaceutical Corporation</a> </strong>(NASDAQ:NYMX)</li>\n<li><strong><a href=\"https://laohu8.com/S/SPRB\">Spruce Biosciences, Inc.</a> </strong>(NASDAQ:SPRB)</li>\n<li><strong><a href=\"https://laohu8.com/S/VVOS\">Vivos Therapeutics</a>, Inc. </strong>(NASDAQ:VVOS)</li>\n<li><strong><a href=\"https://laohu8.com/S/VKTXW\">Viking Therapeutics, Inc.</a> </strong>(NASDAQ:VKTX)</li>\n</ul>\n<h3>Stocks In Focus</h3>\n<h3>Nabriva's Antibiotic Aces a Late-stage Trial In China.</h3>\n<p><strong>Nabriva Therapeutics </strong>(NASDAQ:NBRV) and partner Sinovant Sciences announced positive topline results from Sinovant's Phase 3 bridging study of lefamulin in Chinese adults with community-acquired bacterial pneumonia.</p>\n<p>Lefamulin was shown to be non-inferior to moxifloxacin, with 76.8% of lefamulin-treated patients meeting the efficacy endpoint of Investigator Assessment of Clinical Response at Test of Cure, compared to 71.4% of patients treated with moxifloxacin.</p>\n<p>Consistent with previously reported clinical trial results, lefamulin was observed to be generally safe and well-tolerated, with an overall rate of treatment-emergent adverse events comparable to that of moxifloxacin.</p>\n<p>Sinovant also announced an agreement with Sumitomo Pharmaceuticals to acquire development and commercialization rights for lefamulin in Greater China.</p>\n<p>Nabriva's Lefamulin was approved to treat CABP in the U.S. in August 2019 and is marketed under the trade name Xenleta.</p>\n<p>Nabriva shares jumped 40.54% to $2.08 in after-hours trading.</p>\n<h3>Travere Will Not Pursue Accelerated Approval of Drug to Treat Kidney Scarring In Second Half of 2021</h3>\n<p><strong><a href=\"https://laohu8.com/S/TVTX\">Travere Therapeutics, Inc.</a> </strong>(NASDAQ:TVTX) said it received final pre-NDA meeting minutes, wherein the FDA acknowledged the high unmet need for approved therapies for the treatment of focal segmental glomerulosclerosis but indicated the available data from the interim assessment of the DUPLEX study evaluating its sparsentan for the indication would not be adequate to support an accelerated approval at this time.</p>\n<p>The company said it now no longer expects to submit for accelerated approval for FSGS in the U.S. during the second half of 2021.</p>\n<p>Subject to further discussion with the FDA, the company believes that it may be possible to provide sufficient additional estimated glomerular filtration data from in the first half of 2022. The FDA has encouraged the company to request a follow-up meeting to further explore this option in greater detail, and a Type A meeting is expected to occur in the third quarter of 2021.</p>\n<p>The stock slipped 8.45% to $16.25 in after-hours trading.</p>\n<h3>Larimar's Phase 1 Study of Friedreich's Ataxia Placed On Clinical Hold</h3>\n<p><strong><a href=\"https://laohu8.com/S/LRMR\">Larimar Therapeutics, Inc.</a> </strong>(NASDAQ:LRMR) said the FDA has placed its CTI-1601 clinical program on hold and that it will not be closing a previously announced private placement financing. CTI-1601 is a recombinant fusion protein intended to deliver human frataxin into the mitochondria of patients with Friedreich's ataxia, who are unable to produce enough of this essential protein.</p>\n<p>The clinical hold follows the previous notification by Larimar to the FDA of mortalities that occurred at the highest dose levels in an ongoing 180-day non-human primate toxicology study. CTI-1601 is currently in Phase 1 clinical trials in the U.S.,</p>\n<p>The stock plunged 45.23% to $7.40 in after-hours trading.</p>\n<h3>Qiagen, Mirati to Develop Companion Diagnostic For KRAS Mutant Cancers</h3>\n<p><strong>QIAGEN N.V. </strong>(NYSE:QGEN) and <strong><a href=\"https://laohu8.com/S/MRTX\">Mirati Therapeutics Inc.</a> </strong>(NASDAQ:MRTX) announced a global collaboration to continue developing a tissue-based KRAS companion diagnostic to identify patients with cancers that have a KRAS-G12C mutation who may benefit from treatment with adagrasib, Mirati's investigational oral small molecule inhibitor of KRAS-G12C.</p>\n<p>The agreement initially focuses on a companion diagnostic test for non-small cell lung cancer, and allows for further development of tests for other Mirati oncology programs.</p>\n<h3>NeoVasc Notified of Non-compliance With Nasdaq Listing Standards</h3>\n<p><strong>NeoVasc Inc </strong>(NASDAQ:NVCN) said it has received written notification from the Nasdaq that it is not in compliance with the minimum bid price requirement for continued listing on the Nasdaq.</p>\n<p>The company said it has been provided 180 calendar days, or until November 22, to regain compliance.</p>\n<p><em>Related Link: Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates </em></p>\n<h3>Altimmune's Intranasal COVID-19 Vaccine Found Effective Against South African Variants In Animal Study</h3>\n<p><strong><a href=\"https://laohu8.com/S/ALT\">Altimmune, Inc.</a> </strong>(NASDAQ:ALT) announced new results from a preclinical study demonstrating the ability of its AdCOVID vaccine candidate to neutralize the rapidly emerging SARS-CoV-2 B.1.351 variant of concern that originated in South Africa.</p>\n<p>B.1.351 carries multiple mutations in the receptor-binding domain including the E484K mutation that has been shown to substantially decrease the ability of authorized vaccines to neutralize the virus.</p>\n<p>The stock was up 6.61% at $12.68 in premarket trading Wednesday.</p>\n<h3>Selecta Gains On Insider Buying</h3>\n<p><strong>Selecta Biosciences, Inc. </strong>(NASDAQ:SELB) revealed in a filing that Timothy Springer, a director of the board, bought 2,773,479 shares of the company at $3.19 apiece. The stock gained 9.52% to $3.91 in after-hours trading.</p>\n<h3>Neuroone Announces Uplisting to Nasdaq</h3>\n<p><strong>NeuroOne Medical Technologies Corporation Common Stock </strong>(OTC:NMTC), a MedTech company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, said its shares have been approved to uplist to the Nasdaq. Trading of the shares on the Nasdaq is expected to begin effective Wednesday, under the Company's existing ticker symbol \"NMTC\".</p>\n<h3>On The Radar</h3>\n<h3>Clinical Readouts/Presentations</h3>\n<p><strong><a href=\"https://laohu8.com/S/CHMA\">Chiasma, Inc.</a> </strong>(NASDAQ:CHMA) is scheduled to virtually present at the American Association of Clinical Endocrinology 2021 Annual meeting encore new data from the MPOWERED Phase 3 study of Mycapssa in adults with acromegaly.</p>\n<h3>Earnings</h3>\n<p><strong><a href=\"https://laohu8.com/S/BLRX\">BioLineRx Ltd</a>. </strong>(NASDAQ:BLRX) (before the market open)</p>\n</body></html>\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"IMPL":"Impel NeuroPharma, Inc.","IBB":"生物科技指数ETF-iShares Nasdaq","CCXI":"ChemoCentryx","ALLO":"Allogene Therapeutics Inc.","SWAV":"Shockwave Medical Inc .","ETNB":"89Bio, Inc.","AXLA":"Axcella Health Inc.","LYRA":"Lyra Therapeutics","CRCT":"Cricut, Inc.","PRAH":"PRA Health Sciences","IONS":"Ionis Pharmaceuticals, Inc","NVCN":"Neovasc Inc","VKTX":"Viking Therapeutics, Inc.","MRTX":"Mirati Therapeutics Inc.","AYTU":"Aytu BioScience, Inc.","ICPT":"Intercept Pharmaceuticals","ALT":"Altimmune, Inc.","BLRX":"BioLine Rx","CHRS":"Coherus Biosciences","CEMI":"Chembio Diagnostics","TERN":"Terns Pharmaceuticals, Inc.","KNSA":"Kiniksa Pharmaceuticals Ltd.","PIRS":"Pieris Pharmaceuticals, Inc.","03165":"华夏欧优股对冲","TVTX":"Travere Therapeutics, Inc.","SYNH":"Syneos Health, Inc.","EPIX":"ESSA Pharma Inc.","LRMR":"Larimar Therapeutics, Inc.","FOLD":"爱美医疗","SPRB":"Spruce Biosciences, Inc.","VVOS":"Vivos Therapeutics","QGEN":"快而精医药","WST":"West Pharmaceutical Services Inc","RHHBY":"罗氏控股","BOLT":"Bolt Biotherapeutics, Inc.","NMTC":"NEUROONE MEDICAL TECH","CHMA":"Chiasma, Inc."},"source_url":"https://www.benzinga.com/general/biotech/21/05/21294190/the-daily-biotech-pulse-nabriva-jumps-on-data-larimar-wilts-after-study-put-on-hold-travere-to-de","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"2138801112","content_text":"Here's a roundup of top developments in the biotech space over the last 24 hours.\nScaling The Peaks\n(Biotech Stocks Hitting 52-week Highs May 25)\n\nESSA Pharma Inc. (NASDAQ:EPIX)\nPieris Pharmaceuticals, Inc. (NASDAQ:PIRS) (moved on a R&D pact with Roche Holdings AG (OTC: RHHBY) in the field of respiratory and ophthalmology)\nPLx Pharma Inc. (NASDAQ:PLXP)\nPRA Health Sciences, Inc. (NASDAQ:PRAH)\nShockWave Medical, Inc. (NASDAQ:SWAV)\nSyneos Health, Inc. (NASDAQ:SYNH)\nWest Pharmaceutical Services, Inc. (NYSE:WST)\n\nDown In The Dumps\n(Biotech Stocks Hitting 52-week Lows May 25)\n\n89bio, Inc. (NASDAQ:ETNB)\nAllogene Therapeutics, Inc. (NASDAQ:ALLO)\nAmicus Therapeutics, Inc. (NASDAQ:FOLD)\nAtreca, Inc. (NASDAQ:BCEL)\nAxcella Health Inc. (NASDAQ:AXLA)\nAytu Biopharma, Inc. (NASDAQ:AYTU)\nBolt Biotherapeutics, Inc. (NASDAQ:BOLT)\nChembio Diagnostics, Inc. (NASDAQ:CEMI)\nChemoCentryx, Inc. (NASDAQ:CCXI)\nCoherus BioSciences, Inc. (NASDAQ:CHRS)\nImpel NeuroPharma, Inc. (NASDAQ:IMPL)\nIntercept Pharmaceuticals, Inc. (NASDAQ:ICPT)\nIonis Pharmaceuticals, Inc. (NASDAQ:IONS)\nKiniksa Pharmaceuticals, Ltd. (NASDAQ:KNSA)\nLyra Therapeutics, Inc. (NASDAQ:LYRA)\nNymox Pharmaceutical Corporation (NASDAQ:NYMX)\nSpruce Biosciences, Inc. (NASDAQ:SPRB)\nVivos Therapeutics, Inc. (NASDAQ:VVOS)\nViking Therapeutics, Inc. (NASDAQ:VKTX)\n\nStocks In Focus\nNabriva's Antibiotic Aces a Late-stage Trial In China.\nNabriva Therapeutics (NASDAQ:NBRV) and partner Sinovant Sciences announced positive topline results from Sinovant's Phase 3 bridging study of lefamulin in Chinese adults with community-acquired bacterial pneumonia.\nLefamulin was shown to be non-inferior to moxifloxacin, with 76.8% of lefamulin-treated patients meeting the efficacy endpoint of Investigator Assessment of Clinical Response at Test of Cure, compared to 71.4% of patients treated with moxifloxacin.\nConsistent with previously reported clinical trial results, lefamulin was observed to be generally safe and well-tolerated, with an overall rate of treatment-emergent adverse events comparable to that of moxifloxacin.\nSinovant also announced an agreement with Sumitomo Pharmaceuticals to acquire development and commercialization rights for lefamulin in Greater China.\nNabriva's Lefamulin was approved to treat CABP in the U.S. in August 2019 and is marketed under the trade name Xenleta.\nNabriva shares jumped 40.54% to $2.08 in after-hours trading.\nTravere Will Not Pursue Accelerated Approval of Drug to Treat Kidney Scarring In Second Half of 2021\nTravere Therapeutics, Inc. (NASDAQ:TVTX) said it received final pre-NDA meeting minutes, wherein the FDA acknowledged the high unmet need for approved therapies for the treatment of focal segmental glomerulosclerosis but indicated the available data from the interim assessment of the DUPLEX study evaluating its sparsentan for the indication would not be adequate to support an accelerated approval at this time.\nThe company said it now no longer expects to submit for accelerated approval for FSGS in the U.S. during the second half of 2021.\nSubject to further discussion with the FDA, the company believes that it may be possible to provide sufficient additional estimated glomerular filtration data from in the first half of 2022. The FDA has encouraged the company to request a follow-up meeting to further explore this option in greater detail, and a Type A meeting is expected to occur in the third quarter of 2021.\nThe stock slipped 8.45% to $16.25 in after-hours trading.\nLarimar's Phase 1 Study of Friedreich's Ataxia Placed On Clinical Hold\nLarimar Therapeutics, Inc. (NASDAQ:LRMR) said the FDA has placed its CTI-1601 clinical program on hold and that it will not be closing a previously announced private placement financing. CTI-1601 is a recombinant fusion protein intended to deliver human frataxin into the mitochondria of patients with Friedreich's ataxia, who are unable to produce enough of this essential protein.\nThe clinical hold follows the previous notification by Larimar to the FDA of mortalities that occurred at the highest dose levels in an ongoing 180-day non-human primate toxicology study. CTI-1601 is currently in Phase 1 clinical trials in the U.S.,\nThe stock plunged 45.23% to $7.40 in after-hours trading.\nQiagen, Mirati to Develop Companion Diagnostic For KRAS Mutant Cancers\nQIAGEN N.V. (NYSE:QGEN) and Mirati Therapeutics Inc. (NASDAQ:MRTX) announced a global collaboration to continue developing a tissue-based KRAS companion diagnostic to identify patients with cancers that have a KRAS-G12C mutation who may benefit from treatment with adagrasib, Mirati's investigational oral small molecule inhibitor of KRAS-G12C.\nThe agreement initially focuses on a companion diagnostic test for non-small cell lung cancer, and allows for further development of tests for other Mirati oncology programs.\nNeoVasc Notified of Non-compliance With Nasdaq Listing Standards\nNeoVasc Inc (NASDAQ:NVCN) said it has received written notification from the Nasdaq that it is not in compliance with the minimum bid price requirement for continued listing on the Nasdaq.\nThe company said it has been provided 180 calendar days, or until November 22, to regain compliance.\nRelated Link: Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates \nAltimmune's Intranasal COVID-19 Vaccine Found Effective Against South African Variants In Animal Study\nAltimmune, Inc. (NASDAQ:ALT) announced new results from a preclinical study demonstrating the ability of its AdCOVID vaccine candidate to neutralize the rapidly emerging SARS-CoV-2 B.1.351 variant of concern that originated in South Africa.\nB.1.351 carries multiple mutations in the receptor-binding domain including the E484K mutation that has been shown to substantially decrease the ability of authorized vaccines to neutralize the virus.\nThe stock was up 6.61% at $12.68 in premarket trading Wednesday.\nSelecta Gains On Insider Buying\nSelecta Biosciences, Inc. (NASDAQ:SELB) revealed in a filing that Timothy Springer, a director of the board, bought 2,773,479 shares of the company at $3.19 apiece. The stock gained 9.52% to $3.91 in after-hours trading.\nNeuroone Announces Uplisting to Nasdaq\nNeuroOne Medical Technologies Corporation Common Stock (OTC:NMTC), a MedTech company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, said its shares have been approved to uplist to the Nasdaq. Trading of the shares on the Nasdaq is expected to begin effective Wednesday, under the Company's existing ticker symbol \"NMTC\".\nOn The Radar\nClinical Readouts/Presentations\nChiasma, Inc. (NASDAQ:CHMA) is scheduled to virtually present at the American Association of Clinical Endocrinology 2021 Annual meeting encore new data from the MPOWERED Phase 3 study of Mycapssa in adults with acromegaly.\nEarnings\nBioLineRx Ltd. (NASDAQ:BLRX) (before the market open)","news_type":1},"isVote":1,"tweetType":1,"viewCount":160,"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,"upFlag":false,"length":6,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/160718677"}
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