FDA https://www.benzinga.com/views/taxonomy/term/59 en EMA Safety Committee Reviews Heart Inflammation, Rare Nerve Disorder Reports After Pfizer, AstraZeneca COVID-19 Shots https://www.benzinga.com/general/biotech/21/05/21016760/ema-safety-committee-reviews-heart-inflammation-rare-nerve-disorder-reports-after-pfizer-astrazen <p>European Medical Agency (EMA) is&nbsp;<a class="editor-rtfLink" href="https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-3-6-may-2021" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">reviewing reports</a>&nbsp;of a rare nerve-degenerating disorder in people who received&nbsp;<strong>AstraZeneca Plc&rsquo;s</strong>&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/azn#NASDAQ" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">AZN</a>) COVID-19 vaccine, raising new questions about potential side effects of the shot.</p> <p><strong>What Happened:</strong>&nbsp;As part of a regular review of safety reports for the vaccine, the safety committee of EMA is analyzing data provided by AstraZeneca on cases of Guillain-Barre syndrome (GBS). However, it did not specify the number of cases.</p> <p>The regulator said GBS was identified as a possible adverse event that needed to be specifically monitored during the vaccine&rsquo;s conditional approval process, adding it had requested more detailed data on the cases from AstraZeneca.</p> <p>However, researchers have ...</p><p><a href=https://www.benzinga.com/general/biotech/21/05/21016760/ema-safety-committee-reviews-heart-inflammation-rare-nerve-disorder-reports-after-pfizer-astrazen alt=EMA Safety Committee Reviews Heart Inflammation, Rare Nerve Disorder Reports After Pfizer, AstraZeneca COVID-19 Shots>Full story available on Benzinga.com</a></p> AZN Biotech BNTX COVID-19 Vaccine European Medicines Agency (EMA) Government JNJ MRNA News PFE Health Care FDA General AZN US0463531089 JNJ US4781601046 PFE US7170811035 MRNA US56804Q1022 BNTX News Biotech Government Health Care FDA General Benzinga Fri, 07 May 2021 19:56:10 +0000 Vandana Singh 21016760 at https://www.benzinga.com Analysts React To FDA AdCom Vote On ChemoCentryx's Avacopan, Stock Plunges https://www.benzinga.com/analyst-ratings/analyst-color/21/05/21011933/analysts-react-to-fda-adcom-vote-on-chemocentryxs-avacopan-stock-plunges <ul> <li>Yesterday, the FDA&rsquo;s Arthritis Advisory Committee panelists went through cloudy data while complaining about the design of the Phase 3 trial for&nbsp;<strong>ChemoCentryx Inc&rsquo;s</strong>&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/ccxi#NASDAQ" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">CCXI</a>) avacopan. After going over time, they&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/21/05/21008128/adcomm-split-on-fda-approval-for-chemocentryxs-vasculitis-candidate" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">ended up without consensus</a>.</li> <li>This orphan drug has July 7 as its PDUFA date.</li> <li>What do analysts have to say after the AdCom splits slightly in favor of FDA approving this rare disease drug:</li> <li>Raymond James analyst Steven Seedhouse, on a reduced conviction in avacopan approval, downgraded the stock to Outperform from Strong Buy with the price target more than halved to $51 from $120. <ul> <li class="ql-indent-1">However, if approved, Seedhouse still thinks avacopan is a blockbuster drug and will ...</li></ul></li></ul><p><a href=https://www.benzinga.com/analyst-ratings/analyst-color/21/05/21011933/analysts-react-to-fda-adcom-vote-on-chemocentryxs-avacopan-stock-plunges alt=Analysts React To FDA AdCom Vote On ChemoCentryx&#039;s Avacopan, Stock Plunges>Full story available on Benzinga.com</a></p> Analyst Color Arthritis Biotech Briefs CCXI News Downgrades Health Care Price Target Small Cap FDA Analyst Ratings General CCXI News Analyst Color Biotech Downgrades Health Care Price Target Small Cap FDA Analyst Ratings General Benzinga Fri, 07 May 2021 14:17:16 +0000 Vandana Singh 21011933 at https://www.benzinga.com Orphazyme Shares Plummet As Arimoclomol Flunks In Amyotrophic Lateral Sclerosis Study https://www.benzinga.com/general/biotech/21/05/21009651/orphazyme-shares-plummet-as-arimoclomol-flunks-in-amyotrophic-lateral-sclerosis-study <ul> <li><strong>Orphazyme A/S</strong>&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/orph#NASDAQ" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">ORPH</a>) has announced that the ORARIALS-01 pivotal trial of arimoclomol in amyotrophic lateral sclerosis (ALS)&nbsp;<a class="editor-rtfLink" href="https://www.globenewswire.com/news-release/2021/05/07/2225216/0/en/Orphazyme-announces-topline-data-from-pivotal-trial-of-arimoclomol-in-Amyotrophic-Lateral-Sclerosis-ALS.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">did not meet its primary and secondary endpoints</a>.</li> <li>No important safety signals were reported in the trial.</li> <li>Topline data will be presented at the upcoming virtual European Network to Cure ALS meeting ...</li></ul><p><a href=https://www.benzinga.com/general/biotech/21/05/21009651/orphazyme-shares-plummet-as-arimoclomol-flunks-in-amyotrophic-lateral-sclerosis-study alt=Orphazyme Shares Plummet As Arimoclomol Flunks In Amyotrophic Lateral Sclerosis Study>Full story available on Benzinga.com</a></p> Biotech Briefs multiple sclerosis News ORPH Health Care FDA General ORPH News Biotech Health Care FDA General Benzinga Fri, 07 May 2021 14:02:11 +0000 Vandana Singh 21009651 at https://www.benzinga.com The Daily Biotech Pulse: Split Verdict For Chemocentryx, NKarta-CRISPR In Cell Therapy Collaboration, Orphazyme's Clinical Trial Setback, 2 IPOs https://www.benzinga.com/general/biotech/21/05/21009633/the-daily-biotech-pulse-split-verdict-for-chemocentryx-nkarta-crispr-in-cell-therapy-collaboratio <p>Here&#39;s a roundup of top developments in the biotech space over the last 24 hours.</p> <h3>Scaling The Peaks</h3> <p>(Biotech Stocks Hitting 52-week Highs May 6)</p> <ul> <li><strong>GT Biopharma, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gtbp#NASDAQ">GTBP</a>)</li> <li><strong>IRadimed Corporation </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/irmd#NASDAQ">IRMD</a>)</li> <li><strong>PRA Health Sciences, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/prah#NASDAQ">PRAH</a>)</li> <li><strong>Quest Diagnostics Incorporated </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/dgx#NYSE">DGX</a>)</li> </ul> <h3>Down In The Dumps</h3> <p>(Biotech Stocks Hitting 52-week Lows May 6)</p> <ul> <li><strong>4D pharma plc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/lbps#NASDAQ">LBPS</a>)</li> <li><strong>Acutus Medical, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/afib#NASDAQ">AFIB</a>)</li> <li><strong>Adagene Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/adag#NASDAQ">ADAG</a>)</li> <li><strong>Akouos, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/akus#NASDAQ">AKUS</a>)</li> <li><strong>Akoya Biosciences, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/akya#NASDAQ">AKYA</a>)</li> <li><strong>Aprea Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/apre#NASDAQ">APRE</a>)</li> <li><strong>Aptinyx Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/aptx#NASDAQ">APTX</a>)</li> <li><strong>Aquestive Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/aqst#NASDAQ">AQST</a>)</li> <li><strong>ARCA biopharma, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/abio#NASDAQ">ABIO</a>)</li> <li><strong>Arcturus Therapeutics Holdings Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/arct#NASDAQ">ARCT</a>)</li> <li><strong>Assembly Biosciences, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/asmb#NASDAQ">ASMB</a>)</li> <li><strong>Atea Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/avir#NASDAQ">AVIR</a>)</li> <li><strong>Athersys, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/athx#NASDAQ">ATHX</a>)</li> <li><strong>Atreca, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bcel#NASDAQ">BCEL</a>)</li> <li><strong>Autolus Therapeutics plc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/autl#NASDAQ">AUTL</a>) (reacted to its first-quarter results)</li> <li><strong>AVROBIO, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/avro#NASDAQ">AVRO</a>)</li> <li><strong>Axcella Health Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/axla#NASDAQ">AXLA</a>)</li> <li><strong>Aytu Biopharma, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/aytu#NASDAQ">AYTU</a>) (announced its quarterly results)</li> <li><strong>Baudax Bio, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bxrx#NASDAQ">BXRX</a>)</li> <li><strong>Bellerophon Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/blph#NASDAQ">BLPH</a>)</li> <li><strong>BioXcel Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/btai#NASDAQ">BTAI</a>)</li> <li><strong>Biomerica, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bmra#NASDAQ">BMRA</a>)</li> <li><strong>Cara Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cara#NASDAQ">CARA</a>)</li> <li><strong>Celyad Oncology SA </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cyad#NASDAQ">CYAD</a>)</li> <li><strong>Concert Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cnce#NASDAQ">CNCE</a>)</li> <li><strong>ContraFect Corporation </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cfrx#NASDAQ">CFRX</a>)</li> <li><strong>Cue Biopharma, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cue#NASDAQ">CUE</a>)</li> <li><strong>Decibel Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/dbtx#NASDAQ">DBTX</a>)</li> <li><strong>Deciphera Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/dcph#NASDAQ">DCPH</a>)</li> <li><strong>Dyadic International, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/dyai#NASDAQ">DYAI</a>)</li> <li><strong>Eloxx Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/elox#NASDAQ">ELOX</a>)</li> <li><strong>Epizyme, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/epzm#NASDAQ">EPZM</a>) (announced its first-quarter results)</li> <li><strong>Evofem Biosciences, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/evfm#NASDAQ">EVFM</a>)</li> <li><strong>Finch Therapeutics Group, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/fnch#NASDAQ">FNCH</a>)</li> <li><strong>Galecto, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/glto#NASDAQ">GLTO</a>)</li> <li><strong>Galera Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/grtx#NASDAQ">GRTX</a>)</li> <li><strong>Galmed Pharmaceuticals Ltd. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/glmd#NASDAQ">GLMD</a>)</li> <li><strong>Global Blood Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gbt#NASDAQ">GBT</a>) (reacted to its first-quarter results)</li> <li><strong>GlycoMimetics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/glyc#NASDAQ">GLYC</a>)</li> <li><strong>Haemonetics Corporation </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/hae#NYSE">HAE</a>)</li> <li><strong>Homology Medicines, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/fixx#NASDAQ">FIXX</a>)</li> <li><strong>InflaRx N.V. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ifrx#NASDAQ">IFRX</a>)</li> <li><strong>Inhibrx, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/inbx#NASDAQ">INBX</a>)</li> <li><strong>Inovio Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ino#NASDAQ">INO</a>)</li> <li><strong>Inozyme Pharma, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/inzy#NASDAQ">INZY</a>)</li> <li><strong>Intercept Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/icpt#NASDAQ">ICPT</a>) (announced its first-quarter results)</li> <li><strong>Ionis Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ions#NASDAQ">IONS</a>)</li> <li><strong>Kala Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/kala#NASDAQ">KALA</a>)</li> <li><strong>Karyopharm Therapeutics Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/kpti#NASDAQ">KPTI</a>)</li> <li><strong>Kiniksa Pharmaceuticals, Ltd. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/knsa#NASDAQ">KNSA</a>)</li> <li><strong>Kinnate Biopharma Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/knte#NASDAQ">KNTE</a>)</li> <li><strong>Kiromic BioPharma, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/krbp#NASDAQ">KRBP</a>)</li> <li><strong>LogicBio Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/logc#NASDAQ">LOGC</a>)</li> <li><strong>Longeveron Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/lgvn#NASDAQ">LGVN</a>)</li> <li><strong>Lucira Health, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/lhdx#NASDAQ">LHDX</a>)</li> <li><strong>MediciNova, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mnov#NASDAQ">MNOV</a>)</li> <li><strong>Mesoblast Limited </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/meso#NASDAQ">MESO</a>)</li> <li><strong>Metacrine, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mtcr#NASDAQ">MTCR</a>)</li> <li><strong>NeuBase Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/nbse#NASDAQ">NBSE</a>)</li> <li><strong>NeuroBo Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/nrbo#NASDAQ">NRBO</a>)</li> <li><strong>NuCana plc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ncna#NASDAQ">NCNA</a>)</li> <li><strong>Odonate Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/odt#NASDAQ">ODT</a>)</li> <li><strong>Olema Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/olma#NASDAQ">OLMA</a>)</li> <li><strong>OptiNose, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/optn#NASDAQ">OPTN</a>)</li> <li><strong>OraSure Technologies, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/osur#NASDAQ">OSUR</a>) (reacted to its first-quarter results)</li> <li><strong>Otonomy, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/otic#NASDAQ">OTIC</a>)</li> <li><strong>Oyster Point Pharma, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/oyst#NASDAQ">OYST</a>)</li> <li><strong>PainReform Ltd. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/prfx#NASDAQ">PRFX</a>)</li> <li><strong>Pluristem Therapeutics Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/psti#NASDAQ">PSTI</a>)</li> <li><strong>Protara Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tara#NASDAQ">TARA</a>) (announced ...</li></ul><p><a href=https://www.benzinga.com/general/biotech/21/05/21009633/the-daily-biotech-pulse-split-verdict-for-chemocentryx-nkarta-crispr-in-cell-therapy-collaboratio alt=The Daily Biotech Pulse: Split Verdict For Chemocentryx, NKarta-CRISPR In Cell Therapy Collaboration, Orphazyme&#039;s Clinical Trial Setback, 2 IPOs>Full story available on Benzinga.com</a></p> ABIO ADAG AFIB AKUS AKYA AMRX ANIP APRE APTX AQST ARCT ASMB ATHX AUPH AUTL AVIR AVNS AVRO AXLA AYTU BCEL Biotech BLPH BMRA BTAI BXRX CARA CCXI CFRX CNCE CRSP CUE CYAD DBTX DCPH DGX DYAI Earnings ELAN ELOX EPZM ESALY EVFM FIXX FLDM FNCH GBT GLMD GLTO GLYC GRTX GSK GTBP HAE HOWL IBB ICPT IFRX INBX INO INZY IONS IRMD KALA KNSA KNTE KPTI KRBP LBPS LGVN LHDX LOGC MESO MNOV MRK MTCR NBSE NCNA News NKTX NRBO NTRA ODT OLMA OPTN ORPH OSUR OTIC OYST PCVX Penny Stocks PRAH PRFX PSTI PULM RDUS RLAY SANA SGTX SHC SLNO SNSE SONN SQZ SYRS TARA TRVI TTOO UPC VECT VIR VIVO VOR VYNE WINT YMTX ZGNX Guidance Small Cap FDA IPOs Top Stories Pre-Market Outlook General GBT UPC ELAN CUE HOWL CNCE NBSE INO US45773H1023 MESO KRBP CCXI EVFM CARA OYST ABIO US00211Y1001 IONS GLTO ARCT ELOX GLMD GRTX ATHX US04744L1061 IBB US4642875565 AYTU OLMA SHC BTAI RDUS BXRX LOGC US5414021031 AVIR KNTE ESALY FIXX IRMD TARA MNOV US58468P2065 SYRS SGTX VECT AUTL CFRX SONN OSUR US68554V1089 WINT YMTX NRBO KNSA TTOO PCVX PSTI US72940R1023 CRSP SANA BMRA APTX OTIC AKUS NKTX VIVO US5895841014 SLNO VOR DBTX AVRO PRAH RLAY DGX US74834L1008 KALA SNSE APRE AVNS SQZ INZY GSK US37733W1053 NCNA LHDX AMRX AQST AUPH AFIB HAE US4050241003 GTBP ADAG ICPT VIR BLPH PRFX MRK US58933Y1055 DCPH LGVN EPZM TRVI ASMB CYAD VYNE FLDM US34385P1084 OPTN FNCH GLYC AXLA PULM MTCR ZGNX US98978L1052 IFRX LBPS KPTI INBX NTRA ORPH DYAI ODT AKYA ANIP BCEL Biotech Earnings News Penny Stocks Guidance Small Cap FDA IPOs Top Stories Pre-Market Outlook General Benzinga Fri, 07 May 2021 11:40:07 +0000 Shanthi Rexaline 21009633 at https://www.benzinga.com Adcomm Split On FDA Approval For ChemoCentryx's Vasculitis Candidate https://www.benzinga.com/general/biotech/21/05/21008128/adcomm-split-on-fda-approval-for-chemocentryxs-vasculitis-candidate <ul> <li>The<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/21/05/g21006758/chemocentryx-announces-results-of-fda-advisory-committee-meeting-on-avacopan-in-anca-associated-va" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">&nbsp;FDA&rsquo;s Arthritis Advisory Committee voted</a>&nbsp;10 for and 8 against the approval of&nbsp;<strong>ChemoCentryx Inc&rsquo;s&nbsp;</strong>(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/ccxi#NASDAQ" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">CCXI</a>) investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.</li> <li>The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate to support approval.</li> <li>In the third and final question, the Committee voted 10-8 that the benefit-risk profile is adequate to support approval of ...</li></ul><p><a href=https://www.benzinga.com/general/biotech/21/05/21008128/adcomm-split-on-fda-approval-for-chemocentryxs-vasculitis-candidate alt=Adcomm Split On FDA Approval For ChemoCentryx&#039;s Vasculitis Candidate>Full story available on Benzinga.com</a></p> Biotech Briefs CCXI News Vasculitis Health Care Small Cap FDA General CCXI News Biotech Health Care Small Cap FDA General Benzinga Fri, 07 May 2021 10:47:28 +0000 Vandana Singh 21008128 at https://www.benzinga.com The Daily Biotech Pulse: Merck's Keytruda Snags Another FDA Approval, Moderna Slips On Revenue Miss, Chemocentryx Adcom https://www.benzinga.com/general/biotech/21/05/20985318/the-daily-biotech-pulse-mercks-keytruda-snags-another-fda-approval-moderna-slips-on-revenue-miss- <p>Here&#39;s a roundup of top developments in the biotech space over the last 24 hours:</p> <h3>Scaling The Peaks</h3> <p>(Biotech Stocks Hitting 52-week Highs May 5)</p> <ul> <li><strong>AbbVie Inc. </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/abbv#NYSE">ABBV</a>)</li> <li><strong>Globus Medical, Inc. </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/gmed#NYSE">GMED</a>)</li> <li><strong>GT Biopharma, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gtbp#NASDAQ">GTBP</a>)</li> <li><strong>Penumbra, Inc. </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/pen#NYSE">PEN</a>)</li> <li><strong>PRA Health Sciences, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/prah#NASDAQ">PRAH</a>)</li> <li><strong>Quest Diagnostics Incorporated </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/dgx#NYSE">DGX</a>)</li> </ul> <h3>Down In The Dumps</h3> <p>(Biotech Stocks Hitting 52-week Lows May 5)</p> <ul> <li><strong>ACADIA Pharmaceuticals Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/acad#NASDAQ">ACAD</a>)</li> <li><strong>Acutus Medical, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/afib#NASDAQ">AFIB</a>)</li> <li><strong>Adverum Biotechnologies Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/advm#NASDAQ">ADVM</a>)</li> <li><strong>Agile Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/agrx#NASDAQ">AGRX</a>) (reacted to first-quarter results)</li> <li><strong>Akouos, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/akus#NASDAQ">AKUS</a>)</li> <li><strong>Aptinyx Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/aptx#NASDAQ">APTX</a>)</li> <li><strong>Atea Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/avir#NASDAQ">AVIR</a>)</li> <li><strong>Atreca, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bcel#NASDAQ">BCEL</a>)</li> <li><strong>Autolus Therapeutics plc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/autl#NASDAQ">AUTL</a>)</li> <li><strong>AVROBIO, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/avro#NASDAQ">AVRO</a>)</li> <li><strong>Axcella Health Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/axla#NASDAQ">AXLA</a>)</li> <li><strong>Aytu Biopharma, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/aytu#NASDAQ">AYTU</a>)</li> <li><strong>Baudax Bio, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bxrx#NASDAQ">BXRX</a>) (announced&nbsp;first-quarter results)</li> <li><strong>Bellerophon Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/blph#NASDAQ">BLPH</a>)</li> <li><strong>BioXcel Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/btai#NASDAQ">BTAI</a>)</li> <li><strong>Celyad Oncology SA </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cyad#NASDAQ">CYAD</a>)</li> <li><strong>Concert Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cnce#NASDAQ">CNCE</a>)</li> <li><strong>Decibel Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/dbtx#NASDAQ">DBTX</a>)</li> <li><strong>Deciphera Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/dcph#NASDAQ">DCPH</a>)</li> <li><strong>Dyadic International, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/dyai#NASDAQ">DYAI</a>)</li> <li><strong>Emergent BioSolutions Inc. </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/ebs#NYSE">EBS</a>)</li> <li><strong>Evofem Biosciences, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/evfm#NASDAQ">EVFM</a>)</li> <li><strong>Finch Therapeutics Group, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/fnch#NASDAQ">FNCH</a>)</li> <li><strong>Gain Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ganx#NASDAQ">GANX</a>)</li> <li><strong>Galecto, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/glto#NASDAQ">GLTO</a>)</li> <li><strong>Haemonetics Corporation </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/hae#NYSE">HAE</a>)</li> <li><strong>Ionis Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ions#NASDAQ">IONS</a>) (reacted to first-quarter results)</li> <li><strong>Kala Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/kala#NASDAQ">KALA</a>) (announced first-quarter results)</li> <li><strong>Karyopharm Therapeutics Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/kpti#NASDAQ">KPTI</a>)</li> <li><strong>Longboard Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/lbph#NASDAQ">LBPH</a>)</li> <li><strong>Lyra Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/lyra#NASDAQ">LYRA</a>)</li> <li><strong>Metacrine, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mtcr#NASDAQ">MTCR</a>)</li> <li><strong>MorphoSys AG </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mor#NASDAQ">MOR</a>)</li> <li><strong>NeuroBo Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/nrbo#NASDAQ">NRBO</a>)</li> <li><strong>NextCure, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/nxtc#NASDAQ">NXTC</a>)</li> <li><strong>NuCana plc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ncna#NASDAQ">NCNA</a>)</li> <li><strong>Olema Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/olma#NASDAQ">OLMA</a>)</li> <li><strong>Pieris Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/pirs#NASDAQ">PIRS</a>)</li> <li><strong>Protara Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tara#NASDAQ">TARA</a>)</li> <li><strong>Sana Biotechnology, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sana#NASDAQ">SANA</a>)</li> <li><strong>Sonnet BioTherapeutics Holdings, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sonn#NASDAQ">SONN</a>)</li> <li><strong>SQZ Biotechnologies Company </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/sqz#NYSE">SQZ</a>)</li> <li><strong>Syros Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/syrs#NASDAQ">SYRS</a>)</li> <li><strong>Vaccitech plc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vacc#NASDAQ">VACC</a>) (went public Friday)</li> <li><strong>VectivBio Holding AG </strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vect#NASDAQ">VECT</a>)</li> <li><strong>Voyager Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vygr#NASDAQ">VYGR</a>)</li> <li><strong>VYNE Therapeutics Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vyne#NASDAQ">VYNE</a>)</li> </ul> <h3>Stocks In Focus</h3> <h3>Stealth Biotherapeutics Reports Positive Phase 1 Data For Eamipretide In Retinal Disorder</h3> <p><strong>Stealth BioTherapeutics Corp </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mito#NASDAQ">MITO</a>) presented at the Association for Research in Vision and Ophthalmology meeting with&nbsp;positive data from a post hoc analysis of the Phase 1 ReCLAIM study evaluating elamipretide in patients with non-central geographic atrophy and high risk drusen associated with dry age-related macular degeneration.</p> <p>The data showed that for patients with GA treated with elamipretide for 24-weeks, the improvements from baseline in low light visual acuity, which is the primary efficacy endpoint, were significantly correlated to baseline assessments of mitochondrial health in the ellipsoid zone.</p> <p>&quot;Based on the data presented showing an association between outer retinal features and treatment response to elamipretide, this approach to imaging biomarker interrogation may provide a unique opportunity for clinical trial enrichment and identification of eyes that are more likely to benefit from treatment,&quot; said Dr. Justis Ehlers, a clinical ophthalmologist.</p> <p>The stock jumped 16.67% to $1.40 in after-hours trading.</p> <h3>Sanofi To Work With ...</h3><p><a href=https://www.benzinga.com/general/biotech/21/05/20985318/the-daily-biotech-pulse-mercks-keytruda-snags-another-fda-approval-moderna-slips-on-revenue-miss- alt=The Daily Biotech Pulse: Merck&#039;s Keytruda Snags Another FDA Approval, Moderna Slips On Revenue Miss, Chemocentryx Adcom>Full story available on Benzinga.com</a></p> ABBV ACAD ACOR ADAP ADCT ADVM AFIB AGEN AGRX AGTC AKUS ALBO ALDX APTX ATHX ATNX ATRS AUPH AUTL AVIR AVRO AXLA AXNX AYTU BCEL BCRX BDSI Biotech BLPH BTAI BXRX CCXI CEMI CHMA CHRS CLBS CNCE COLL CORT CSII CTMX CYAD CYTK DBTX DCPH DGX DRNA DVAX DYAI Earnings EBS EIGR ENDP ENTA EPZM EVFM FLDM FLGT FNCH FULC GANX GH GLTO GMED GTBP GTHX HAE HBIO IBB ICPT ICUI INSM IONS IOVA IRWD KALA KPTI KURA LBPH LYRA MITO MOR MRK MRNA MSON MTCR NBY NCNA News NKTR NRBO NTLA NTRA NVCN NXTC OLMA OSUR PBYI PEN Penny Stocks PIRS PODD PRAH PTN QDEL REGN RETA SANA SNY SONN SPRO SQZ SYRS TARA TCDA TECH TTOO TVTX TWST TXG VACC VECT VIR VYGR VYNE WBA XLRN ZGNX ZTS Guidance Small Cap FDA General IRWD US46333X1081 EIGR MOR EPZM AUTL IBB US4642875565 AUPH LYRA CEMI US1635721004 NTLA NBY US66987P1021 XLRN APTX ICUI US44930G1076 BLPH AKUS AFIB FLDM US34385P1084 AVIR PTN US6960774031 KPTI AVRO INSM US4576693075 PIRS VYNE ZGNX US98978L1052 ADVM ACAD US0042251084 ALDX TCDA MSON US6048711039 ADAP MTCR DYAI SYRS ACOR US00484M1062 AGTC TWST NKTR US6402681083 COLL GLTO CCXI FLGT ADCT CNCE AXNX OSUR US68554V1089 CYAD OLMA ATRS ALBO AGEN US00847G7051 DRNA VIR PODD US45784P1012 CLBS TVTX GMED GTHX ATHX US04744L1061 AGRX MITO QDEL US74838J1016 CHMA NTRA LBPH VECT ATNX BCRX US09058V1035 TTOO AXLA REGN US75886F1075 PEN SANA NRBO IOVA BDSI US09060J1060 PRAH NXTC SPRO US83171G1031 CTMX GANX DBTX KALA CORT US2183521028 CHRS BCEL TECH US8783771004 VYGR FNCH ICPT NCNA CSII US1416191062 NVCN FULC DGX US74834L1008 KURA VACC PBYI GTBP CYTK US23282W1009 GH MRNA US56804Q1022 EBS US29089Q1058 IONS ZTS DCPH DVAX US2681581029 SQZ BXRX HAE US4050241003 MRK US58933Y1055 AYTU ABBV EVFM ENDP US29264F2056 TXG TARA SNY US80105N1054 RETA ENTA BTAI HBIO US4169061052 WBA SONN Biotech Earnings News Penny Stocks Guidance Small Cap FDA General Benzinga Thu, 06 May 2021 11:49:39 +0000 Shanthi Rexaline 20985318 at https://www.benzinga.com Biden Administration Backs Waiving IP Protections For COVID-19 Vaccines, Pharma Industry Rebukes Move https://www.benzinga.com/general/biotech/21/05/20982778/biden-administration-backs-waiving-ip-protections-for-covid-19-vaccines-pharma-industry-rebukes-m <ul> <li>The closely watched issue of patent rights for COVID-19 vaccines garnered headlines again as the Biden administration came out in favor of a proposal at the World Trade Organization to suspend intellectual property protections for shots.</li> <li>U.S. Trade Representative Katherine Tai announced that the&nbsp;<a class="editor-rtfLink" href="https://twitter.com/AmbassadorTai/status/1390021205974003720" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Biden administration supports waiving IP protections</a>&nbsp;for COVID-19 vaccines. &ldquo;This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures,&rdquo; Tai said in the statement.</li> <li>Tai said the U.S. would actively participate in World Trade Organization text-based negotiations to make the waiver happen. She added that such discussions would take time, given the complexity of the issue involved.</li> <li>Tai also added that with the U.S. vaccine supply secured, the ...</li></ul><p><a href=https://www.benzinga.com/general/biotech/21/05/20982778/biden-administration-backs-waiving-ip-protections-for-covid-19-vaccines-pharma-industry-rebukes-m alt=Biden Administration Backs Waiving IP Protections For COVID-19 Vaccines, Pharma Industry Rebukes Move>Full story available on Benzinga.com</a></p> AZN Biotech BNTX Briefs COVID-19 Vaccine Government GSK JNJ MRNA News NVX PFE Regulations Health Care FDA General NVX US67069X1046 AZN US0463531089 GSK US37733W1053 JNJ US4781601046 PFE US7170811035 MRNA US56804Q1022 BNTX News Biotech Government Regulations Health Care FDA General Benzinga Thu, 06 May 2021 11:20:03 +0000 Vandana Singh 20982778 at https://www.benzinga.com This Biotech Stock Could See A Big Move If It Breaks Out Of The Pennant It's Forming https://www.benzinga.com/general/biotech/21/05/20972351/this-biotech-stock-could-see-a-big-move-if-it-breaks-out-of-the-pennant-its-forming <p><strong>Humanigen Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/hgen#NASDAQ">HGEN</a>) shares made gains Wednesday&nbsp;</p> <p>following the publication of results from a Phase 3&nbsp;randomized double-blind placebo-controlled study.</p> <p>The study demonstrated the efficacy and safely of the company&#39;s lenzilumab in hospitalized COVID-19 patients. Lenzilumab was found to significantly improve survival without ventilation in hospitalized patients with COVID-19.</p> <p><img alt="hgendaily5-5-21.png" src="https://cdn.benzinga.com/files/u285825/hgendaily5-5-21.png" style="height:400px; width:640px" /></p> <h3>Humanigen Daily Chart Analysis</h3> <ul> <li>Shares of Humanigen are forming into what technical traders&nbsp;call a pennant pattern. The pennant pattern is very large, originating in July 2020. It is thought by traders that the bigger the pattern is, the bigger the breakout will be.</li> <li>The ...</li></ul><p><a href=https://www.benzinga.com/general/biotech/21/05/20972351/this-biotech-stock-could-see-a-big-move-if-it-breaks-out-of-the-pennant-its-forming alt=This Biotech Stock Could See A Big Move If It Breaks Out Of The Pennant It&#039;s Forming>Full story available on Benzinga.com</a></p> Biotech HGEN LABU Long Ideas News Sector ETFs Short Ideas Health Care Technicals Small Cap FDA Movers Trading Ideas ETFs General LABU HGEN Long Ideas Sector ETFs News Biotech Short Ideas Health Care Technicals Small Cap FDA Movers Trading Ideas ETFs General Benzinga Wed, 05 May 2021 20:50:44 +0000 Tyler Bundy 20972351 at https://www.benzinga.com Pfizer's Hospira To Call Back Hospital Anesthetics Due To Mislabeling https://www.benzinga.com/general/biotech/21/05/20970231/pfizers-hospira-to-call-back-hospital-anesthetics-due-to-mislabeling <ul> <li><strong>Pfizer&rsquo;s Inc</strong>&nbsp;(NYSE:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/pfe#NYSE" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">PFE</a>) Hospira will&nbsp;<a class="editor-rtfLink" href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-issues-voluntary-nationwide-recall-one-lot-05-bupivacaine-hydrochloride-injection-usp-and" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">recall one lot of each of the injectable hospital anesthetics</a>&nbsp;bupivacaine hydrochloride (HCL) and lidocaine HCL following an investigation revealing that a portion of each lot was mislabeled as the other product.</li> <li>Hospira&rsquo;s assessment of the potential risk to patients concluded that the use of the impacted product is likely to cause adverse events of moderate to ...</li></ul><p><a href=https://www.benzinga.com/general/biotech/21/05/20970231/pfizers-hospira-to-call-back-hospital-anesthetics-due-to-mislabeling alt=Pfizer&#039;s Hospira To Call Back Hospital Anesthetics Due To Mislabeling>Full story available on Benzinga.com</a></p> Biotech Briefs News PFE Health Care FDA General PFE US7170811035 News Biotech Health Care FDA General Benzinga Wed, 05 May 2021 18:16:57 +0000 Vandana Singh 20970231 at https://www.benzinga.com Eli Lilly Under FDA Scrutiny At Its COVID-19 Drug Manufacturing Facilities Amid Staff Accusations: Reuters https://www.benzinga.com/general/biotech/21/05/20966366/eli-lilly-under-fda-scrutiny-at-its-covid-19-drug-manufacturing-facilities-amid-staff-accusations <ul> <li><strong>Eli Lilly &amp; Co</strong>&nbsp;(NYSE:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/lly#NYSE" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">LLY</a>)&nbsp;<a class="editor-rtfLink" href="https://www.reuters.com/business/healthcare-pharmaceuticals/exclusive-lilly-hit-by-staff-accusations-fda-scrutiny-covid-drug-factories-2021-05-05/" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">employees have reportedly accused a factory executive of altering documents</a>&nbsp;required by the FDA to downplay quality control problems at Branchburg, New Jersey plant producing its COVID-19 treatment.</li> <li>Reuters notes that an unsigned report was filed last month, which claims that the executive rewrote findings by Lilly&rsquo;s technical experts to make the conclusions appear more favorable to the company.</li> <li>The findings involved the production of drugs, including ...</li></ul><p><a href=https://www.benzinga.com/general/biotech/21/05/20966366/eli-lilly-under-fda-scrutiny-at-its-covid-19-drug-manufacturing-facilities-amid-staff-accusations alt=Eli Lilly Under FDA Scrutiny At Its COVID-19 Drug Manufacturing Facilities Amid Staff Accusations: Reuters>Full story available on Benzinga.com</a></p> Biotech Briefs Government LLY News Reuters Health Care FDA General LLY US5324571083 News Biotech Government Health Care FDA General Benzinga Wed, 05 May 2021 18:08:34 +0000 Vandana Singh 20966366 at https://www.benzinga.com Lyft, GM Earnings Impress, Lifting Shares Ahead Of Uber's Report Slated For Later https://www.benzinga.com/news/earnings/21/05/20965987/lyft-gm-earnings-impress-lifting-shares-ahead-of-ubers-report-slated-for-later <p>If you wanted more evidence of reopening progress,&nbsp;<strong>Lyft&rsquo;s</strong>&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/lyft#NASDAQ">LYFT</a>) earnings arguably provided it yesterday.</p> <p>The ride-sharing company saw shares post big pre-market gains after reporting a narrower than expected loss, above consensus revenue and solid guidance for the rest of the year. Now&nbsp;<strong>Uber</strong>&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/uber#NYSE">UBER</a>), which reports this afternoon, has a tough act to follow. Shares of LYFT spiked more than 5% in pre-market trading.&nbsp;</p> <p>&ldquo;More people started moving again&rdquo; in Q1, LYFT&rsquo;s chief financial officer said, which is the kind of thing you want to hear if you&rsquo;re excited about getting back to normal. Average daily ride volume grew each month, Lyft said, with the steepest recovery in March. And for people who miss traveling by plane, the good news is that LYFT&rsquo;s average daily airport rides were up more than 65% in April relative to January.&nbsp;</p> <p>What&rsquo;s more impressive is that all this happened even when most people weren&rsquo;t back at work yet. More companies are starting to talk about getting employees back to the office, so that could give ride-sharing companies an opportunity to do even better.&nbsp;</p> <p>Then this morning,&nbsp;<strong>General Motors&nbsp;</strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/gm#NYSE">GM</a>) easily beat Wall Street&rsquo;s earnings expectations but came up just short of consensus on revenue. It looks like investors aren&rsquo;t punishing the company for that small miss, as shares rose more than 3% in the pre-market hours. Maybe the fact that GM reaffirmed its 2021 guidance was enough to soothe any hurt feelings over revenue.</p> <p>The reaffirmed guidance from GM included an impact from the global shortage of semiconductor chips, by the way, so it doesn&rsquo;t look like that&rsquo;s going to necessarily handicap the company. This was an important thing for them to get across.&nbsp;</p> <p>The solid earnings from these two appeared to help stabilize a market that was going downhill yesterday. Major indices built in slight gains ahead of the opening bell. Earnings drive stocks, and the nice run of earnings continues.</p> <p>Forward progress early today might also reflect a bit of spillover buying after yesterday&rsquo;s late comeback from the lowest points of the day, but it&rsquo;s unclear how much buying interest remains with stocks still near record highs. It looks like we may bounce around in a range for a while as we get ready for the jobs report on Friday (see more below). There&rsquo;s also ISM Services data later today.</p> <h2>Not Like Old Times: Yellen Rate Hike Talk Spooks Stocks</h2> <p>Maybe you remember that time when, as Fed Chair, Janet Yellen gave Wall Street a scare by talking about how rates might need to rise to make sure the economy doesn&rsquo;t overheat.&nbsp;</p> <p>If you don&rsquo;t, it&rsquo;s understandable, because it&rsquo;s hard to remember many occasions when Yellen&mdash;&nbsp; a well-known dove&mdash;did that back in the day. While Yellen did raise rates slowly over the course of her time at the Fed, she did it very cautiously and without fireworks. Also, the economy really wasn&rsquo;t in much danger then of overheating, with slow growth being the big problem. That&rsquo;s why it might have felt a bit disconcerting to hear those words from her as Treasury Secretary yesterday, and helps explain the market&rsquo;s subsequent dive.</p> <p>It wouldn&rsquo;t be fair, however, to just blame Yellen. First of all, she didn&rsquo;t specifically call for a rate hike. She just said rates might have to rise to avoid the economy overheating, implying more of a natural progression considering the strong growth we&rsquo;ve seen so far this year. Already, many analysts see the 10-year yield on a path back toward 2%, though that&rsquo;s separate from the Fed raising rates.&nbsp;</p> <p>Yellen also walked back her words later Tuesday, according to The Wall Street Journal, saying she wasn&rsquo;t predicting nor recommending that the Federal Reserve raise interest rates, and doesn&rsquo;t think there&rsquo;s going to be an inflation problem.&nbsp;</p> <p>Second, the market was on its heels even before Yellen spoke. Almost none of the big Tech companies got a lift last week despite overwhelmingly impressive earnings results, and some &ldquo;mega-cap&rdquo; Tech stocks like&nbsp;<strong>Apple</strong>&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/aapl#NASDAQ">AAPL</a>) and&nbsp;<strong>Tesla</strong>&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tsla#NASDAQ">TSLA</a>) still haven&rsquo;t made it back to their February highs even ...</p><p><a href=https://www.benzinga.com/news/earnings/21/05/20965987/lyft-gm-earnings-impress-lifting-shares-ahead-of-ubers-report-slated-for-later alt=Lyft, GM Earnings Impress, Lifting Shares Ahead Of Uber&#039;s Report Slated For Later>Full story available on Benzinga.com</a></p> AAPL AVGO Earnings GM Government Lyft LYFT MRK News NVDA PFE Regulations TDAmeritrade tech stocks TSLA Uber UBER FDA Markets Tech Media General AAPL US0378331005 NVDA US67066G1040 GM US37045V1008 MRK US58933Y1055 PFE US7170811035 AVGO SG9999006241 TSLA US88160R1014 UBER LYFT News Earnings Government Regulations FDA Markets Tech Media General Benzinga Wed, 05 May 2021 14:19:46 +0000 JJ Kinahan 20965987 at https://www.benzinga.com India Gives Emergency Use Nod To Roche-Regeneron's COVID-19 Antibody Cocktail https://www.benzinga.com/general/biotech/21/05/20963770/india-gives-emergency-use-nod-to-roche-regenerons-covid-19-antibody-cocktail <ul> <li><strong>Roche Holdings AG</strong>&nbsp;(OTCMKTS: RHHBY) has&nbsp;<a class="editor-rtfLink" href="https://microbiozindia.com/roche-receives-emergency-use-authorisation-in-india-for-its-investigational-antibody-cocktail-used-in-the-treatment-of-covid-19/" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">received Emergency Use Authorization in India</a>&nbsp;for its investigational antibody cocktail (casirivimab and imdevimab) for treatment of COVID-19.</li> <li>Cipla will partner for pan-India distribution. Roche and its partner&nbsp;<strong>Regeneron Pharmaceuticals Inc</strong>&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/regn#NASDAQ" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">REGN</a>) are collaborating at a global level.</li> <li>The approval was based on ...</li></ul><p><a href=https://www.benzinga.com/general/biotech/21/05/20963770/india-gives-emergency-use-nod-to-roche-regenerons-covid-19-antibody-cocktail alt=India Gives Emergency Use Nod To Roche-Regeneron&#039;s COVID-19 Antibody Cocktail>Full story available on Benzinga.com</a></p> Biotech Briefs COVID-19 Vaccine India News REGN RHHBF RHHBY RHHVF Health Care Contracts FDA General REGN US75886F1075 RHHBY US7711951043 RHHVF RHHBF News Biotech Health Care Contracts FDA General Benzinga Wed, 05 May 2021 13:19:02 +0000 Vandana Singh 20963770 at https://www.benzinga.com The Daily Biotech Pulse: Athenex, NeoGenomics And Amryt In M&A Mix, European Nod For Roche's Cancer Immunotherapy, Earnings Deluge Continues https://www.benzinga.com/general/biotech/21/05/20960066/the-daily-biotech-pulse-athenex-neogenomics-and-amryt-in-m-a-mix-european-nod-for-roches-cancer-i <p>Here&#39;s a roundup of top developments in the biotech space over the last 24 hours.</p> <h3>Scaling The Peaks</h3> <p>(Biotech Stocks Hitting 52-week Highs May 4)</p> <ul> <li><strong>AbbVie Inc. </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/abbv#NYSE">ABBV</a>)</li> <li><strong>BioLineRx Ltd. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/blrx#NASDAQ">BLRX</a>) (<a href="https://www.benzinga.com/general/biotech/21/05/20944094/why-cocrystal-pharma-chemocentryx-neuronetics-and-biolinerx-are-moving-today">reacted </a> to a positive data readout)</li> <li><strong>BioNTech SE &ndash; ADR </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bntx#NASDAQ">BNTX</a>)</li> <li><strong>Celcuity Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/celc#NASDAQ">CELC</a>)</li> <li><strong>Cocrystal Pharma, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cocp#NASDAQ">COCP</a>) (moved on continuing momentum imparted by the company&#39;s update on its COVID-19 program)</li> <li><strong>Lantheus Holdings Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/lnth#NASDAQ">LNTH</a>)(announced its first-quarter results)</li> <li><strong>PRA Health Sciences, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/prah#NASDAQ">PRAH</a>)</li> <li><strong>Precipio, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/prpo#NASDAQ">PRPO</a>) (announced its COVID-19 rapid antibody test is now available on <strong>Amazon, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/amzn#NASDAQ">AMZN</a>))</li> <li><strong>Quest Diagnostics Incorporated </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/dgx#NYSE">DGX</a>) (reacted to an analyst upgrade)</li> <li><strong>SI-BONE, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sibn#NASDAQ">SIBN</a>) (reacted to its first-quarter results)</li> </ul> <h3>Down In The Dumps</h3> <p>(Biotech Stocks Hitting 52-week Lows May 4)</p> <ul> <li><strong>ACADIA Pharmaceuticals Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/acad#NASDAQ">ACAD</a>)</li> <li><strong>Acutus Medical, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/afib#NASDAQ">AFIB</a>)</li> <li><strong>Adverum Biotechnologies Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/advm#NASDAQ">ADVM</a>)</li> <li><strong>Agile Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/agrx#NASDAQ">AGRX</a>)</li> <li><strong>Akoya Biosciences, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/akya#NASDAQ">AKYA</a>)</li> <li><strong>Aptinyx Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/aptx#NASDAQ">APTX</a>)</li> <li><strong>Aquestive Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/aqst#NASDAQ">AQST</a>)</li> <li><strong>Assembly Biosciences, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/asmb#NASDAQ">ASMB</a>)</li> <li><strong>Atea Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/avir#NASDAQ">AVIR</a>)</li> <li><strong>Athenex, Inc., </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/atnx#NASDAQ">ATNX</a>),</li> <li><strong>AVROBIO, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/avro#NASDAQ">AVRO</a>)</li> <li><strong>Aziyo Biologics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/azyo#NASDAQ">AZYO</a>)</li> <li><strong>Bellerophon Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/blph#NASDAQ">BLPH</a>)</li> <li><strong>BioXcel Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/btai#NASDAQ">BTAI</a>)</li> <li><strong>Cara Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cara#NASDAQ">CARA</a>)</li> <li><strong>Celyad Oncology SA </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cyad#NASDAQ">CYAD</a>)</li> <li><strong>ChemoCentryx, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ccxi#NASDAQ">CCXI</a>) (moved in reaction to mixed review by FDA staffers regarding its investigational asset to treat anti-neutrophil cytoplasmic auto-antibody-associated vasculitis)</li> <li><strong>Concert Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cnce#NASDAQ">CNCE</a>) (announced its first quarter results)</li> <li><strong>Decibel Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/dbtx#NASDAQ">DBTX</a>)</li> <li><strong>Emergent BioSolutions Inc. </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/ebs#NYSE">EBS</a>)</li> <li><strong>Evofem Biosciences, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/evfm#NASDAQ">EVFM</a>)</li> <li><strong>Flexion Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/flxn#NASDAQ">FLXN</a>)</li> <li><strong>Galecto, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/glto#NASDAQ">GLTO</a>) (announced first-quarter results)</li> <li><strong>GlycoMimetics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/glyc#NASDAQ">GLYC</a>)</li> <li><strong>Gracell Biotechnologies Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/grcl#NASDAQ">GRCL</a>)</li> <li><strong>Haemonetics Corporation </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/hae#NYSE">HAE</a>)</li> <li><strong>Hoth Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/hoth#NASDAQ">HOTH</a>)</li> <li><strong>InflaRx N.V. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ifrx#NASDAQ">IFRX</a>)</li> <li><strong>Inovio Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ino#NASDAQ">INO</a>)</li> <li><strong>iRhythm Technologies, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/irtc#NASDAQ">IRTC</a>)</li> <li><strong>Karyopharm Therapeutics Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/kpti#NASDAQ">KPTI</a>)</li> <li><strong>Kinnate Biopharma Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/knte#NASDAQ">KNTE</a>)</li> <li><strong>Kiromic BioPharma, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/krbp#NASDAQ">KRBP</a>)</li> <li><strong>LogicBio Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/logc#NASDAQ">LOGC</a>)</li> <li><strong>Longboard Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/lbph#NASDAQ">LBPH</a>)</li> <li><strong>Lucira Health, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/lhdx#NASDAQ">LHDX</a>)</li> <li><strong>MediciNova, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mnov#NASDAQ">MNOV</a>)</li> <li><strong>Mesoblast Limited </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/meso#NASDAQ">MESO</a>)</li> <li><strong>Metacrine, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mtcr#NASDAQ">MTCR</a>)</li> <li><strong>NeuroPace, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/npce#NASDAQ">NPCE</a>)</li> <li><strong>NuCana plc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ncna#NASDAQ">NCNA</a>)</li> <li><strong>Olema Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/olma#NASDAQ">OLMA</a>)</li> <li><strong>Pluristem Therapeutics Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/psti#NASDAQ">PSTI</a>)</li> <li><strong>Protara Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tara#NASDAQ">TARA</a>)</li> <li><strong>PTC Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ptct#NASDAQ">PTCT</a>)</li> <li><strong>Quidel Corporation </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/qdel#NASDAQ">QDEL</a>)</li> <li><strong>Relay Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/rlay#NASDAQ">RLAY</a>)</li> <li><strong>Sana Biotechnology, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sana#NASDAQ">SANA</a>)</li> <li><strong>Seagen Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sgen#NASDAQ">SGEN</a>)</li> <li><strong>Sigilon Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sgtx#NASDAQ">SGTX</a>)</li> <li><strong>Syros Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/syrs#NASDAQ">SYRS</a>)</li> <li><strong>Vaccitech plc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vacc#NASDAQ">VACC</a>) (IPOed Friday)</li> <li><strong>Vallon Pharmaceuticals Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vlon#NASDAQ">VLON</a>)</li> <li><strong>Vor Biopharma Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vor#NASDAQ">VOR</a>)</li> <li><strong>Voyager Therapeutics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vygr#NASDAQ">VYGR</a>)</li> <li><strong>VYNE Therapeutics Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vyne#NASDAQ">VYNE</a>)</li> </ul> <h3>Stocks In Focus</h3> <h3>Amryt Pharma to Buy Chiasma In an All-Stock Deal</h3> <p><strong>Amryt </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/amyt#NASDAQ">AMYT</a>) announced the signing of a definitive agreement to acquire <strong>Chiasma, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/chma#NASDAQ">CHMA</a>) in an all-stock combination. ...</p><p><a href=https://www.benzinga.com/general/biotech/21/05/20960066/the-daily-biotech-pulse-athenex-neogenomics-and-amryt-in-m-a-mix-european-nod-for-roches-cancer-i alt=The Daily Biotech Pulse: Athenex, NeoGenomics And Amryt In M&amp;A Mix, European Nod For Roche&#039;s Cancer Immunotherapy, Earnings Deluge Continues>Full story available on Benzinga.com</a></p> ABBV ABUS ACAD ADPT ADVM AERI AFIB AGLE AGRX AKYA ALLO AMPE AMYT AMZN APTX AQST ARNA ASMB ATNX AVIR AVRO AXGN AZYO Biotech BLPH BLRX BNTX BTAI CARA CCXI CDNA CELC CHMA CLVS CNCE COCP CTSO CYAD DBTX DGX DMAC Earnings EBS EDIT ESPR EVFM EYPT FLXN GBT GKOS GLTO GLYC GRCL HAE HOTH HZNP IBB IFRX INO INSP IONS IRTC KIDS KNTE KPTI KRBP LBPH LHDX LNTH LOGC LUMO MESO MNOV MTCR NBIX NCNA NEO News NPCE NUVA NVRO OCUL OLMA OM OSUR PASG Penny Stocks PRAH PRPO PSTI PTCT QDEL RGNX RHHBY RIGL RLAY SANA SGEN SGTX SIBN SRPT SUPN SYN SYRS TARA TARS TCON TLSA TNDM TPTX TXG UTHR VACC VCEL VERU VLON VNDA VOR VYGR VYNE Offerings Small Cap FDA Top Stories Pre-Market Outlook AGRX RLAY UTHR US91307C1027 GBT VLON SRPT CELC INO US45773H1023 ADPT AFIB VNDA US9216591084 ABUS AKYA SIBN IFRX ACAD US0042251084 OCUL VYNE DGX US74834L1008 RGNX NPCE AXGN EVFM AMZN US0231351067 CDNA MTCR EBS US29089Q1058 VYGR VACC DBTX BTAI ARNA US0400471027 LNTH AZYO HAE US4050241003 MESO NEO EYPT IBB US4642875565 COCP KRBP RHHBY US7711951043 IONS ABBV APTX INSP LOGC US5414021031 PRAH TARS KIDS EDIT OM AVRO MNOV US58468P2065 NVRO GLTO SYN US8719481058 AGLE ESPR AQST NBIX US64125C1099 TXG OLMA AMPE AVIR PTCT ALLO NUVA US6707041058 TCON KNTE BLRX ADVM AERI HOTH DMAC OSUR US68554V1089 VCEL SGTX HZNP SYRS GLYC BNTX PSTI US72940R1023 BLPH GRCL CLVS IRTC KPTI TARA QDEL US74838J1016 ASMB LBPH CTSO ATNX TNDM US64128B1089 PASG RIGL US7665596034 CYAD SANA CCXI PRPO CNCE LUMO SGEN US8125781026 CHMA VOR SUPN VERU FLXN AMYT TPTX GKOS LHDX TLSA NCNA CARA Biotech Earnings News Penny Stocks Offerings Small Cap FDA Top Stories Pre-Market Outlook Benzinga Wed, 05 May 2021 11:43:28 +0000 Shanthi Rexaline 20960066 at https://www.benzinga.com Why Cocrystal Pharma, Chemocentryx, Neuronetics And BioLineRx Are Moving Today https://www.benzinga.com/general/biotech/21/05/20944094/why-cocrystal-pharma-chemocentryx-neuronetics-and-biolinerx-are-moving-today <p><strong>Cocrystal Pharma, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cocp#NASDAQ">COCP</a>), <strong>ChemoCentryx, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ccxi#NASDAQ">CCXI</a>), <strong>Neuronetics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/stim#NASDAQ">STIM</a>) and <strong>BioLineRx Ltd. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/blrx#NASDAQ">BLRX</a>) are among the biggest health care <a href=" https://www.benzinga.com/news/21/05/20933240/26-stocks-moving-in-tuesdays-pre-market-session"> movers </a> Tuesday.</p> <p><strong>Cocrystal Shines On COVID-19 Pipeline: </strong> Cocrystal, a clinical-stage biotech engaged in the development of anti-viral therapeutics, announced Monday it is aggressively developing novel coronavirus protease inhibitors for COVID-19 prophylactic and therapeutic use.</p> <p>&quot;These drug candidates bind to a highly conserved region of the active site of SARS-CoV-2 protease that is required for SARS-CoV-2 viral replication,&quot; the company said.</p> <p>Due to their novel mechanism of action, these protease inhibitors are likely to be effective against new variants of SARS-CoV-2, it added.</p> <p>After a muted reaction on Monday, the stock has taken off Tuesday. Reacting ...</p><p><a href=https://www.benzinga.com/general/biotech/21/05/20944094/why-cocrystal-pharma-chemocentryx-neuronetics-and-biolinerx-are-moving-today alt=Why Cocrystal Pharma, Chemocentryx, Neuronetics And BioLineRx Are Moving Today>Full story available on Benzinga.com</a></p> Biotech BLRX CCXI COCP Earnings News Penny Stocks STIM Small Cap FDA Movers Trading Ideas BLRX CCXI COCP STIM News Earnings Biotech Penny Stocks Small Cap FDA Movers Trading Ideas Benzinga Tue, 04 May 2021 17:45:43 +0000 Shanthi Rexaline 20944094 at https://www.benzinga.com ChemoCentryx Stock Plunges As FDA Briefing Document Casts Doubt On Vasculitis Candidate Avacopan's Data https://www.benzinga.com/general/biotech/21/05/20945235/chemocentryx-stock-plunges-as-fda-briefing-document-casts-doubt-on-vasculitis-candidate-avacopans <ul> <li><strong>ChemoCentryx Inc</strong>&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/ccxi#NASDAQ" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">CCXI</a>) shares plunged after an FDA briefing document indicates the agency has &ldquo;several areas of concerns&rdquo; with its vasculitis candidate, avacopan.</li> <li>The&nbsp;<a class="editor-rtfLink" href="https://www.fda.gov/media/148176/download" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">FDA document</a>&nbsp;raised questions regarding the &ldquo;interpretability of the data and the clinical meaningfulness of these results&rdquo; as summarized below: <ul> <li class="ql-indent-1">At Week 26, the proportion of patients in disease ...</li></ul></li></ul><p><a href=https://www.benzinga.com/general/biotech/21/05/20945235/chemocentryx-stock-plunges-as-fda-briefing-document-casts-doubt-on-vasculitis-candidate-avacopans alt=ChemoCentryx Stock Plunges As FDA Briefing Document Casts Doubt On Vasculitis Candidate Avacopan&#039;s Data>Full story available on Benzinga.com</a></p> Biotech Briefs CCXI News Vasculitis Health Care Small Cap FDA General CCXI News Biotech Health Care Small Cap FDA General Benzinga Tue, 04 May 2021 17:19:01 +0000 Vandana Singh 20945235 at https://www.benzinga.com