FDA https://www.benzinga.com/views/taxonomy/term/59 en The Daily Biotech Pulse: Positive Readout For Kezar, AstraZeneca Stitches Oncology Partnership, D-Day For Merck's Triple Combo Antibiotic https://www.benzinga.com/general/biotech/20/06/16178099/the-daily-biotech-pulse-positive-readout-for-kezar-astrazeneca-stitches-oncology-partnership-d-da <p>Here&#39;s a roundup of top developments in the biotech space over the last 24 hours:</p> <h3>Scaling The Peak</h3> <p>(Biotech Stocks Hitting 52-week Highs June 3)</p> <ul> <li><strong>Arena Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/arna#NASDAQ">ARNA</a>)</li> <li><strong>BioMarin Pharmaceutical Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bmrn#NASDAQ">BMRN</a>)</li> <li><strong>Black Diamond Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bdtx#NASDAQ">BDTX</a>)</li> <li><strong>Fortress Biotech </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/fbio#NASDAQ">FBIO</a>)</li> <li><strong>Imara Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/imra#NASDAQ">IMRA</a>)</li> <li><strong>Inari Medical Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/nari#NASDAQ">NARI</a>)</li> <li><strong>Intellia Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ntla#NASDAQ">NTLA</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>Keros Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/kros#NASDAQ">KROS</a>)</li> <li><strong>ORIC Pharmaceuticals Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/oric#NASDAQ">ORIC</a>)</li> <li><strong>Phathom Pharmaceuticals Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/phat#NASDAQ">PHAT</a>)</li> <li><strong>Pliant Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/plrx#NASDAQ">PLRX</a>) (went public&nbsp;Wednesday)</li> <li><strong>Protara Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tara#NASDAQ">TARA</a>)</li> <li><strong>Qiagen NV </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/qgen#NYSE">QGEN</a>)</li> <li><strong>Turning Point Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tptx#NASDAQ">TPTX</a>)</li> <li><strong>United Therapeutics Corporation </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/uthr#NASDAQ">UTHR</a>)</li> </ul> <h3>Down In The Dumps</h3> <p>(Biotech Stocks Hitting 52-week Lows June 3)</p> <ul> <li><strong>Cellectar Biosciences Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/clrb#NASDAQ">CLRB</a>) (priced a&nbsp;$20-million common stock offering)</li> <li><strong>Cumberland Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cpix#NASDAQ">CPIX</a>)</li> <li><strong>Genfit SA </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gnft#NASDAQ">GNFT</a>)</li> </ul> <h3>Stocks In Focus</h3> <h3>Kezar Reports Positive Early Stage Results For KZR-616 In Systemic Lupus Erythematosus</h3> <p><strong>Kezar Life Sciences, Inc. </strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/kzr#Nasdaq">KZR</a>) announced updated results from the Phase 1b portion of the Phase 1b/2 MISSION study, which is evaluating the safety and tolerability of KZR-616 in patients with systemic lupus erythematosus with and without nephritis, showing overall improvements across seven measures of disease activity.</p> <p>Two of two patients with lupus nephritis experienced a greater than 50% reduction in proteinuria, a biomarker of disease severity, according to the company. A positive safety and tolerability profile was observed with step-up dosing of KZR-616, Kezar said.&nbsp;</p> <p>The stock jumped 48.32% to $6.63 in premarket trading Thursday.</p> <h3>AcelRx Ends Bid For Tetraphase</h3> <p>Following a bidding war for <strong> Tetraphase Pharmaceuticals Inc </strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ttph#NASDAQ">TTPH</a>) that saw the contenders sweetening their offers a few times, <strong> AcelRx Pharmaceuticals Inc </strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/acrx#NASDAQ">ACRX</a>), one of the contenders, said it does not intend to revise further its ...</p><p><a href=https://www.benzinga.com/general/biotech/20/06/16178099/the-daily-biotech-pulse-positive-readout-for-kezar-astrazeneca-stitches-oncology-partnership-d-da alt=The Daily Biotech Pulse: Positive Readout For Kezar, AstraZeneca Stitches Oncology Partnership, D-Day For Merck&#039;s Triple Combo Antibiotic>Full story available on Benzinga.com</a></p> ACRX ALRN ARNA AZN BDTX Biotech BMRN CLRB CPIX FBIO GILD GLPG GNFT IBB IMRA KALA KROS KZR M&A MRK NARI News NTLA NVS OBSV ORIC Penny Stocks PHAT PLRX QGEN RHHBY TARA TLSA TPTX TTPH TWST UTHR XBI Offerings FDA Trading Ideas XBI US78464A8707 ARNA US0400471027 BMRN US09061G1013 GILD US3755581036 IBB US4642875565 QGEN NL0000240000 TPTX UTHR US91307C1027 AZN US0463531089 MRK US58933Y1055 NVS US66987V1098 RHHBY US7711951043 CPIX US2307701092 ACRX US00444T1007 ALRN TLSA TTPH CLRB GLPG FBIO NTLA OBSV KALA KZR TWST GNFT PHAT TARA BDTX IMRA KROS ORIC NARI PLRX News M&A Biotech Penny Stocks Offerings FDA Trading Ideas Benzinga Thu, 04 Jun 2020 12:13:59 +0000 Shanthi Rexaline 16178099 at https://www.benzinga.com Why Axonics Modulation's Stock Is Trading Higher Today https://www.benzinga.com/news/20/06/16170558/why-axonics-modulations-stock-is-trading-higher-today <p><strong>Axonics Modulation Technologies Inc</strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/axnx#NASDAQ">AXNX</a>) shares are trading higher on Wednesday.</p> <p>The company reported FDA approval of its wireless patient remote control with MartMRI technology.</p> <p>Axonics Modulation Technologies Inc is a U.S.&nbsp;based medical technology company. It focuses on the design, development, ...</p><p><a href=https://www.benzinga.com/news/20/06/16170558/why-axonics-modulations-stock-is-trading-higher-today alt=Why Axonics Modulation&#039;s Stock Is Trading Higher Today>Full story available on Benzinga.com</a></p> AXNX News why it's moving FDA AXNX News FDA Benzinga Wed, 03 Jun 2020 15:29:06 +0000 Tanzeel Akhtar 16170558 at https://www.benzinga.com FSD Pharma Jumps 200% After FDA Nod For Initiating Proof-Of-Concept Study Of COVID-19 Treatment https://www.benzinga.com/general/biotech/20/06/16168526/fsd-pharma-jumps-200-after-fda-nod-for-initiating-proof-of-concept-study-of-covid-19-treatment <p>Shares of <strong>FSD Pharma Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/huge#NASDAQ">HUGE</a>) are <a href="https://www.benzinga.com/news/20/06/16167607/31-stocks-moving-in-wednesdays-pre-market-session">advancing strongly</a> Wednesday following an announcement regarding a potential COVID-19 drug.</p> <h3><strong>What Happened?</strong></h3> <p><a href="https://www.benzinga.com/markets/cannabis/20/01/15083866/fsd-pharma-to-start-trading-on-nasdaq-this-week">FSD </a> said the FDA has approved its IND application for studying FSD-201 for the treatment of SARS-CoV-2, the virus that causes COVID-19. FSD-201, according to the company, is ultramicronized palmitoylethanolamide, or PEA.</p> <p>The company clarified that it&#39;s focused on developing the investigational asset for its anti-inflammatory properties to avoid the ...</p><p><a href=https://www.benzinga.com/general/biotech/20/06/16168526/fsd-pharma-jumps-200-after-fda-nod-for-initiating-proof-of-concept-study-of-covid-19-treatment alt=FSD Pharma Jumps 200% After FDA Nod For Initiating Proof-Of-Concept Study Of COVID-19 Treatment>Full story available on Benzinga.com</a></p> Biotech Cannabis Covid-19 HUGE News Penny Stocks Health Care FDA Movers Trading Ideas General HUGE News Biotech Penny Stocks Cannabis Health Care FDA Movers Trading Ideas General Benzinga Wed, 03 Jun 2020 12:55:24 +0000 Shanthi Rexaline 16168526 at https://www.benzinga.com The Daily Biotech Pulse: Regulatory Delay For Novartis' Multiple Sclerosis Drug, FSD Gets Nod For COVID-19 Study https://www.benzinga.com/general/biotech/20/06/16167710/the-daily-biotech-pulse-regulatory-delay-for-novartis-multiple-sclerosis-drug-fsd-gets-nod-for-co <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><em>(Biotech Stocks Hitting 52-week Highs June 2)</em></p> <ul> <li><strong>Agenus Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/agen#NASDAQ">AGEN</a>)(announced FDA clearance of its IND for evaluating its allogeneic iNKT therapy as a COVID-19 treatment option)</li> <li><strong>Arena Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/arna#NASDAQ">ARNA</a>)(moved on a positive readout for a rival ulcerative colitis drug from <strong> Bristol-Myers Squibb Co </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/bmy#NYSE">BMY</a>))</li> <li><strong>argenx SE &ndash; ADR </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/argx#NASDAQ">ARGX</a>)</li> <li><strong>Bio-Rad Laboratories, Inc. Class A Common Stock </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/bio#NYSE">BIO</a>)</li> <li><strong>Biohaven Pharmaceutical Holding Co Ltd </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/bhvn#NYSE">BHVN</a>)</li> <li><strong>Cardiff Oncology Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/crdf#NASDAQ">CRDF</a>)</li> <li><strong>Fortress Biotech </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/fbio#NASDAQ">FBIO</a>)</li> <li><strong>Imara Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/imra#NASDAQ">IMRA</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>ORIC Pharmaceuticals Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/oric#NASDAQ">ORIC</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>Qiagen NV </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/qgen#NYSE">QGEN</a>)</li> <li><strong>Regeneron Pharmaceuticals Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/regn#NASDAQ">REGN</a>)</li> <li><strong>Tenax Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tenx#NASDAQ">TENX</a>)(<a href=" https://www.benzinga.com/general/biotech/20/06/16160336/whats-driving-shares-of-nano-cap-pharma-tenax-higher"> announced </a> a positive Phase 3 readout)</li> <li><strong>Trillium Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tril#NASDAQ">TRIL</a>)</li> <li><strong>Turning Point Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tptx#NASDAQ">TPTX</a>)</li> <li><strong>Unity Biotechnology Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ubx#NASDAQ">UBX</a>)</li> <li><strong>Vermillion, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vrml#NASDAQ">VRML</a>)</li> <li><strong>Y-mAbs Therapeutics, Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ymab#NASDAQ">YMAB</a>)(announced FDA acceptance of its BLA for Danyelza for the treatment of patients with relapsed/refractory high-risk neuroblastoma)</li> </ul> <h3>Down In The Dumps</h3> <p><em>(Biotech Stocks Hitting 52-week Lows June 2)</em></p> <ul> <li><strong>Exagen Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/xgn#NASDAQ">XGN</a>)</li> </ul> <h3>Stocks In Focus</h3> <h3>Novartis Announces 3-Month Extension In Regulatory Review Period For Multiple Sclerosis Drug</h3> <p><strong>Novartis AG </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/nvs#NYSE">NVS</a>) announced the receipt of a notification from the FDA, extending the review of its sNDA for ofatumumab for patients with relapsing multiple sclerosis. The company said the regulatory action would ...</p><p><a href=https://www.benzinga.com/general/biotech/20/06/16167710/the-daily-biotech-pulse-regulatory-delay-for-novartis-multiple-sclerosis-drug-fsd-gets-nod-for-co alt=The Daily Biotech Pulse: Regulatory Delay For Novartis&#039; Multiple Sclerosis Drug, FSD Gets Nod For COVID-19 Study>Full story available on Benzinga.com</a></p> AGEN ANIK ANPC ARGX ARNA BHVN BIO Biotech BMY CRDF EVFM FBIO HUGE IBB IMRA KALA KNSA LLY News NVAX NVS ORIC Penny Stocks QGEN REGN REPL TARA TENX TPTX TRIL UBX VRML XBI XGN YMAB Health Care Offerings FDA Management IPOs Top Stories Pre-Market Outlook Trading Ideas General XBI US78464A8707 AGEN US00847G7051 ANIK US0352551081 ARNA US0400471027 IBB US4642875565 NVAX US6700021040 QGEN NL0000240000 REGN US75886F1075 TPTX BIO US0905722072 BMY US1101221083 LLY US5324571083 NVS US66987V1098 VRML US92407M2061 REPL TRIL TENX FBIO BHVN ARGX KALA EVFM UBX KNSA HUGE YMAB XGN ANPC TARA IMRA ORIC CRDF News Biotech Penny Stocks Health Care Offerings FDA Management IPOs Top Stories Pre-Market Outlook Trading Ideas General Benzinga Wed, 03 Jun 2020 11:39:19 +0000 Shanthi Rexaline 16167710 at https://www.benzinga.com The Daily Biotech Pulse: FDA Nod For Roche's Combo Therapy In Liver Cancer, Allena Rips Higher, Pfizer To Invest Up To $500M In Biotechs https://www.benzinga.com/general/biotech/20/06/16157918/the-daily-biotech-pulse-fda-nod-for-roches-combo-therapy-in-liver-cancer-allena-rips-higher-pfize <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 June 1)</p> <ul> <li><strong>Adaptimmune Therapeutics PLC &ndash; ADR </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/adap#NASDAQ">ADAP</a>)</li> <li><strong>Aileron Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alrn#NASDAQ">ALRN</a>) (announced positive interim results for its Phase 1b/2 study of ALRN-6924 as an agent to protect patients against chemotherapy-induced toxicity)</li> <li><strong>argenx SE &ndash; ADR </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/argx#NASDAQ">ARGX</a>)</li> <li><strong>Bio-Rad Laboratories, Inc. Class A Common Stock </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/bio#NYSE">BIO</a>)</li> <li><strong>Cerus Corporation </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cers#NASDAQ">CERS</a>)</li> <li><strong>Dynavax Technologies Corporation </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/dvax#NASDAQ">DVAX</a>) (reacted to reports of partner Sinovac expressing confidence in its coronavirus vaccine)</li> <li><strong>Emergent Biosolutions Inc </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/ebs#NYSE">EBS</a>) (announced $628-million dollar BARDA funding for rapid development of COVID-19 vaccine candidates)</li> <li><strong>Imara Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/imra#NASDAQ">IMRA</a>)</li> <li><strong>Immunovant Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/imvt#NASDAQ">IMVT</a>)</li> <li><strong>Inari Medical Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/nari#NASDAQ">NARI</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>MEI Pharma Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/meip#NASDAQ">MEIP</a>)</li> <li><strong>Novo Nordisk A/S </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/nvo#NYSE">NVO</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>TFF Pharmaceuticals Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tffp#NASDAQ">TFFP</a>)</li> <li><strong>Turning Point Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tptx#NASDAQ">TPTX</a>)</li> <li><strong>Vermillion, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vrml#NASDAQ">VRML</a>)</li> <li><strong>Y-mAbs Therapeutics, Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ymab#NASDAQ">YMAB</a>)</li> </ul> <h3>Down In The Dumps</h3> <p>(Biotech Stocks Hitting 52-week Lows June 1)</p> <ul> <li><strong>Ocugen Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ocgn#NASDAQ">OCGN</a>) (announced discontinuation of Phase 3 trial of OCU300 for ocular Graft vs. Host Disease)</li> </ul> <h3>Stocks In Focus</h3> <h3>Roche&#39;s Cancer Therapy Combo Approved For Treatment-Na&iuml;ve Liver Cancer</h3> <p><strong>Roche Holdings AG Basel ADR Common Stock </strong>(OTC: <a class="ticker" href="https://www.benzinga.com/stock/rhhby#OTC">RHHBY</a>) said the FDA approved its Tecentriq in combination with Avastin for the treatment of people with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.</p> <h3>Allena&#39;s Momentum Carries Through Ahead of Conference Presentation</h3> <p><strong>Allena Pharmaceuticals Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alna#NASDAQ">ALNA</a>) shares were surging ahead of the company&#39;s presentation at the Jefferies Virtual Healthcare Conference. The shares were higher in Monday&#39;s regular session, reacting to an initiation by H.C. Wainwright with a Buy rating and $10 price target.</p> <p>Analyst Edward White said the biopharma is an &quot;undervalued enzyme therapeutic company.&quot;</p> <p>Following a 31.55% jump to $2.21 in Monday&#39;s regular session, Allena shares were rallying by 35.29% to $2.99 in Tuesday&#39;s premarket session.&nbsp;</p> <h3>Esperion Shares Slip As Shareholder Lawsuit Accorded Class Action Status</h3> <p><strong>Esperion Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/espr#NASDAQ">ESPR</a>) ...</p><p><a href=https://www.benzinga.com/general/biotech/20/06/16157918/the-daily-biotech-pulse-fda-nod-for-roches-combo-therapy-in-liver-cancer-allena-rips-higher-pfize alt=The Daily Biotech Pulse: FDA Nod For Roche&#039;s Combo Therapy In Liver Cancer, Allena Rips Higher, Pfizer To Invest Up To $500M In Biotechs>Full story available on Benzinga.com</a></p> ACRX ADAP ALLO ALNA ALRN ARGX AYTU BIO Biotech CERC CERS DVAX EBS ESPR GH GTHX HTGC IBB IMRA IMVT KALA KLDO MEIP MYOV NARI News NTLA NVO OCGN OSUR Penny Stocks PFE RHHBY SNY TARA TFFP TPTX TTPH VRML XBI YMAB Financing Offerings FDA XBI US78464A8707 CERS US1570851014 DVAX US2681581029 HTGC US4270965084 IBB US4642875565 OSUR US68554V1089 TPTX BIO US0905722072 EBS US29089Q1058 NVO US6701002056 PFE US7170811035 SNY US80105N1054 RHHBY US7711951043 VRML US92407M2061 ACRX US00444T1007 ALRN KLDO MEIP TTPH ESPR GH ADAP CERC AYTU NTLA MYOV GTHX ARGX KALA ALNA YMAB ALLO TFFP OCGN IMVT TARA IMRA NARI News Biotech Penny Stocks Financing Offerings FDA Benzinga Tue, 02 Jun 2020 11:45:45 +0000 Shanthi Rexaline 16157918 at https://www.benzinga.com Attention Biotech Investors: Mark Your Calendar For June PDUFA Dates https://www.benzinga.com/general/biotech/20/06/16135090/attention-biotech-investors-mark-your-calendar-for-june-pdufa-dates <p>Despite the FDA tied up with COVID-19-related activities, May turned out to be a positive month for biopharma companies from the perspective of drug approvals. Three new molecular entities were approved during the month and several other <a href="https://www.benzinga.com/general/biotech/20/05/16106601/why-shares-of-womens-health-focused-biopharma-evofem-are-rallying"> drugs </a> also received the nod.</p> <p>Meanwhile, <strong>Blueprint Medicines Corp </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bpmc#NASDAQ">BPMC</a>) faced disappointment at the FDA altar, as its NDA for avapritinib for treating fourth-line gastrointestinal stromal tumor was clamped with a complete response letter.</p> <p>Here are the key PDUFA dates scheduled for the unfolding month.</p> <h3><strong>Merck&#39;s Antibiotic Combo Up Before FDA For Label Expansion</strong></h3> <ul> <li><strong>Company: </strong> <strong>Merck &amp; Co., Inc. </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/mrk#NYSE">MRK</a>)</li> <li><strong>Type of Application: </strong> sNDA</li> <li><strong>Candidate: </strong> Recarbrio</li> <li><strong>Indication: </strong> hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia</li> <li><strong>Date: </strong> June 4</li> </ul> <p>Recarbrio is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a betalactamase inhibitor, indicated for the treatment of complicated urinary tract infections and complicated intra-abdominal infections.</p> <h3>Viela Eyes Commercial Status With its Autoimmune Disorder Drug Approval</h3> <ul> <li><strong>Company: </strong> <strong>Viela Bio Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vie#NASDAQ">VIE</a>)</li> <li><strong>Type of Application: </strong> BLA</li> <li><strong>Candidate: </strong> inebilizumab</li> <li><strong>Indication: </strong> neuromyelitis optica spectrum disorder, or NMOSD</li> <li><strong>Date: </strong> June 11</li> </ul> <p>The FDA accepted the BLA for the investigational anti-CD19 monoclonal antibody on April 27, 2019. NMOSD is a rare autoimmune disease characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis.</p> <p>The company said in its first-quarter earnings release it has begun preparations for potential regulatory approval, hiring and training market access and sales teams and deploying MSLs. The company expects to commercialize the drug shortly after.</p> <h3><strong>Can Merck&#39;s Wonder Cancer Drug Snag Another Approval</strong></h3> <ul> <li><strong>Company: </strong> Merck</li> <li><strong>Type of Application: </strong> sBLA</li> <li><strong>Candidate: </strong> Keytruda</li> <li><strong>Indication: </strong> solid tumors</li> <li><strong>Date: </strong> June 16</li> <li>Merck announced April 7 FDA acceptance of the application with priority review. <a href=" https://www.benzinga.com/analyst-ratings/analyst-color/20/04/15907712/merck-analysts-focus-on-fundamentals-keytruda-strength-following-guidance-cut"> Keytruda </a> as a monotherapy is being evaluated for treating adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high, as determined by an FDA-approved test, who have progressed following prior treatment and who have no satisfactory alternative treatment options</li> </ul> <h3><strong>Ultragenyx Seeks Label Expansion For Partnered Drug To Treat Low Serum Phosphate Levels</strong></h3> <ul> <li><strong>Company: </strong> <strong>Ultragenyx Pharmaceutical Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/rare#NASDAQ">RARE</a>) and Kyowa Kirin</li> <li><strong>Type of Application: </strong> sBLA</li> <li><strong>Candidate: </strong> burosumab</li> <li><strong>Indication: </strong> hypophosphatemia</li> <li><strong>Date: </strong> June 18</li> </ul> <p>The FDA accepted the application for priority review Feb. 27. Burosumab is a fully human monoclonal IgG1 antibody, which works against the phosphaturic hormone FGF23. This hormone reduces serum ...</p><p><a href=https://www.benzinga.com/general/biotech/20/06/16135090/attention-biotech-investors-mark-your-calendar-for-june-pdufa-dates alt=Attention Biotech Investors: Mark Your Calendar For June PDUFA Dates>Full story available on Benzinga.com</a></p> ABBV Biotech BPMC CHMA EPZM EVOK HRTX IBB ICPT KPTI MNLO MRK NBIX NBRV News PCRX RARE VIE XBI ZGNX Health Care FDA Top Stories Trading Ideas General XBI US78464A8707 IBB US4642875565 NBIX US64125C1099 MRK US58933Y1055 PCRX US6951271005 ZGNX US98978L1052 VIE ICPT ABBV EPZM EVOK KPTI RARE HRTX BPMC CHMA NBRV MNLO News Biotech Health Care FDA Top Stories Trading Ideas General Benzinga Mon, 01 Jun 2020 20:00:31 +0000 Shanthi Rexaline 16135090 at https://www.benzinga.com The Week Ahead In Biotech: ASCO, Menlo And Merck FDA Decisions, IPOs In The Spotlight https://www.benzinga.com/general/biotech/20/05/16140357/the-week-ahead-in-biotech-asco-menlo-and-merck-fda-decisions-ipos-in-the-spotlight <p>Biotech stocks could not sustain the uptrend in the holiday-shortened week, even as traders digested COVID-19-related news flow, clinical readouts, ASCO presentations and a few FDA approvals.</p> <p><strong>Arca Biopharma Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/abio#NASDAQ">ABIO</a>) was the best performing biotech stock of the week, as it rallied in reaction to an <a href="https://www.benzinga.com/general/biotech/20/05/16128864/arca-biopharma-rallies-200-on-covid-19-plans">announcement</a> from the company regarding testing of its pipeline asset for COVID-19-associated coagulopathy.</p> <p>The week also saw <strong>Merck &amp; Co., Inc. </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/mrk#NYSE">MRK</a>) taking a giant leap of faith into the <a href="https://www.benzinga.com/general/biotech/20/05/16106601/why-shares-of-womens-health-focused-biopharma-evofem-are-rallying">COVID fray</a> after remaining non-committal thus long.</p> <p>Here are the key catalysts for the unfolding week.</p> <h3>Conferences</h3> <p>Jefferies Virtual Healthcare Conference: June 2-4<br /> European Academy of Allergy and Clinical Immunology, or EAACI, Digital Conference 2020: June 6-8</p> <h3>PDUFA Dates</h3> <p>The FDA is set to rule on <strong>Menlo Therapeutics Inc&#39;s </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mnlo#NASDAQ">MNLO</a>) FMX103 - 1.5% minocycline foam -, which came into its stable via its Foamix acquisition, as a ...</p><p><a href=https://www.benzinga.com/general/biotech/20/05/16140357/the-week-ahead-in-biotech-asco-menlo-and-merck-fda-decisions-ipos-in-the-spotlight alt=The Week Ahead In Biotech: ASCO, Menlo And Merck FDA Decisions, IPOs In The Spotlight>Full story available on Benzinga.com</a></p> ABBV ABIO ASCO AYLA AZN Biotech BMY CLDX Earnings IBB MNLO MRK NBIX News Penny Stocks PLX REPL XBI Health Care FDA IPOs Top Stories Trading Ideas General PLX US74365A1016 XBI US78464A8707 ABIO US00211Y1001 CLDX US15117B1035 IBB US4642875565 NBIX US64125C1099 AZN US0463531089 BMY US1101221083 MRK US58933Y1055 REPL ABBV MNLO AYLA News Earnings Biotech Penny Stocks Health Care FDA IPOs Top Stories Trading Ideas General Benzinga Sat, 30 May 2020 13:25:31 +0000 Shanthi Rexaline 16140357 at https://www.benzinga.com Deciphera Prepares To Collect Revenue After First FDA Approval: 'We Are Well-Positioned' https://www.benzinga.com/general/biotech/20/05/16106792/deciphera-prepares-to-collect-revenue-after-first-fda-approval-we-are-well-positioned <p>After 17 years of clinical work, <strong>Deciphera Pharmaceuticals Inc</strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/dcph#NASDAQ">DCPH</a>) finally has&nbsp;a marketable product. The Food and Drug Administration approved Qinlock as a fourth-line treatment of gastrointestinal stromal tumors&nbsp;earlier this month.&nbsp;</p> <p>The kinase inhibitor will be Deciphera&rsquo;s first sustainable revenue generator, possibly boasting the $32,000-per-month price tag of peer therapies.Yet Deciphera isn&rsquo;t yet projecting profitability.</p> <p>&ldquo;We are not yet focused on a real path to profitability,&rdquo; CEO Steve Hoerter told Benzinga, adding that the practice is common across the industry. &ldquo;We&rsquo;re focused on investing capital in the programs we have and getting those programs to important value inflection points as we generate additional data.&rdquo;</p> <p><a href="https://www.benzinga.com/stock/dcph">The company</a> has &ldquo;a number of places to invest,&rdquo; he said.</p> <h3>Deciphera&#39;s Lead Candidate</h3> <p>Deciphera designs kinase inhibitors with the &ldquo;potential to result in the ability to overcome resistance to other therapies and prevent downstream resistance mutations,&rdquo; Hoerter said.</p> <p>Qinlock, which addresses a range of genetic mutations, had been shown to reduce the risk of disease progression and death by 85% in its late-stage trial.</p> <p>On Friday, Deciphera released a presentation from the ASCO 2020 Virtual Scientific Program showing that GIST patients receiving Qinlock maintained five key measures of ...</p><p><a href=https://www.benzinga.com/general/biotech/20/05/16106792/deciphera-prepares-to-collect-revenue-after-first-fda-approval-we-are-well-positioned alt=Deciphera Prepares To Collect Revenue After First FDA Approval: &#039;We Are Well-Positioned&#039;>Full story available on Benzinga.com</a></p> ABC ASCO Biotech DCPH News Steve Hoerter FDA Top Stories Exclusives Interview General ABC US03073E1055 DCPH News Biotech FDA Top Stories Exclusives Interview General Benzinga Fri, 29 May 2020 15:49:25 +0000 Elizabeth Balboa 16106792 at https://www.benzinga.com The Daily Biotech Pulse: ASCO Presentations Begin, Altimmune Pops On Insider Buying, Immutep Gets R&D Grant https://www.benzinga.com/general/biotech/20/05/16136395/the-daily-biotech-pulse-asco-presentations-begin-altimmune-pops-on-insider-buying-immutep-gets-r- <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><em>(Biotech Stocks Hitting 52-week Highs May 28)</em></p> <ul> <li><strong>ADC Therapeutics SA </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/adct#NYSE">ADCT</a>) (IPOed May 15)</li> <li><strong>Aerpio Pharmaceuticals Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/arpo#NASDAQ">ARPO</a>)(<a href="https://www.benzinga.com/general/biotech/20/05/16125282/the-daily-biotech-pulse-phasebio-to-start-potential-pivotal-covid-19-trial-immunomedics-ceo-quits"> announced </a> a collaboration study for razuprotafib in COVID-19 treatment)</li> <li><strong>Aileron Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alrn#NASDAQ">ALRN</a>)</li> <li><strong>Arca Biopharma Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/abio#NASDAQ">ABIO</a>) (<a href="https://www.benzinga.com/general/biotech/20/05/16128864/arca-biopharma-rallies-200-on-covid-19-plans"> reacted </a> to its planned foray into COVID-19 treatment)</li> <li><strong>argenx SE &ndash; ADR </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/argx#NASDAQ">ARGX</a>)</li> <li><strong>Bio-Rad Laboratories, Inc.&nbsp;</strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/bio#NYSE">BIO</a>)</li> <li><strong>BioSpecifics Technologies Corp. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bstc#NASDAQ">BSTC</a>)</li> <li><strong>ChemoCentryx Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ccxi#NASDAQ">CCXI</a>)</li> <li><strong>GENMAB A/S/S ADR </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gmab#NASDAQ">GMAB</a>)(announced positive topline Phase 3 data for daratumumab in light-chain amyloidosis)</li> <li><strong>Imara Inc NASDAQ: </strong>(IMRA)</li> <li><strong>Liquidia Technologies Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/lqda#NASDAQ">LQDA</a>)</li> <li><strong>Mersana Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrsn#NASDAQ">MRSN</a>)</li> <li><strong>Protagonist Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ptgx#NASDAQ">PTGX</a>)</li> <li><strong>Qiagen NV </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/qgen#NYSE">QGEN</a>)</li> <li><strong>Tenax Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tenx#NASDAQ">TENX</a>)</li> <li><strong>Turning Point Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tptx#NASDAQ">TPTX</a>)</li> <li><strong>Vermillion, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vrml#NASDAQ">VRML</a>)</li> </ul> <h3>Down In The Dumps</h3> <p><em>(Biotech Stocks Hitting 52-week Lows May 28)</em></p> <ul> <li><strong>Zafgen Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/zfgn#NASDAQ">ZFGN</a>)</li> </ul> <h3>Stocks In Focus</h3> <h3>Karyopharm to Present Positive Selinexor Data In Multiple Myeloma Patients At ASCO</h3> <p><strong>Karyopharm Therapeutics Inc </strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/kpti#NASDAQ">KPTI</a>) announced detailed results from the pivotal Phase 3 BOSTON study that evaluated once-weekly selinexor in combination with once-weekly Velcade and low-dose dexamethasone, or SVd, compared to the standard twice-weekly Velcade plus low-dose dexamethasone, or Vd, in second-line to fourth-line setting in multiple myeloma patients. The data is to be presented at the ASCO 2020 Virtual Scientific Program.</p> <p>The SVd arm, according to the company, showed a statistically significant increase of 47% in median progression-free survival compared to the Vd arm. The overall response rate was 76.4% for the SVd arm compared to 62.3% for the Vd arm.</p> <p>The stock rose 7.71% to $20.25 in after-hours trading.</p> <h3>Eisai, Merck Announce ASCO Presentations</h3> <p><strong>Eisai Co., Ltd </strong>(OTC: <a class="ticker" href="https://www.benzinga.com/stock/esaly#OTC">ESALY</a>) and <strong> Merck &amp; Co., Inc. </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/mrk#NYSE">MRK</a>) said results from two trials evaluating the former&#39;s Lenvima, plus the latter&#39;s anti-PD-1 therapy Keytruda in patients with unresectable hepatocellular carcinoma, or HCC, with no ...</p><p><a href=https://www.benzinga.com/general/biotech/20/05/16136395/the-daily-biotech-pulse-asco-presentations-begin-altimmune-pops-on-insider-buying-immutep-gets-r- alt=The Daily Biotech Pulse: ASCO Presentations Begin, Altimmune Pops On Insider Buying, Immutep Gets R&amp;D Grant>Full story available on Benzinga.com</a></p> ABIO ADAP ADCT AGIO ALLO ALRN ALT AMGN APTO ARGX ARPO ARVN ATNX AUTL AVEO AZN BIO Biotech Biotechnology BPMC BSTC CCXI CLVS CRDF CRVS CTMX CYAD DCPH DMPI ESALY GMAB GNCA GOSS HARP Health Care HTBX IBB IMGN IMMP IMMU IMV INO IOVA IPHA KPTI KURA LQDA MEIP MGNX MRK MRKR MRNS MRSN MRUS News NXTC ONCT ONCY Penny Stocks PFE PTGX QGEN RHHBY SBPH SLRX TENX TPTX TRIL VRML XBI XNCR ZFGN ZIOP Offerings FDA Top Stories Pre-Market Outlook Trading Ideas INO US45773H1023 XBI US78464A8707 ABIO US00211Y1001 ADCT AMGN US0311621009 BSTC US0909311062 IBB US4642875565 IMGN US45253H1014 IMMU US4529071080 ONCY CA6823101077 QGEN NL0000240000 TPTX ZIOP US98973P1012 AZN US0463531089 BIO US0905722072 MRK US58933Y1055 PFE US7170811035 RHHBY US7711951043 VRML US92407M2061 AVEO US0535881090 ALRN CLVS ALT CCXI MEIP ONCT ESALY SLRX IMMP IMV HTBX AGIO MGNX KPTI GNCA ZFGN MRNS XNCR DMPI APTO TRIL TENX ADAP BPMC CYAD CTMX MRUS KURA CRVS SBPH PTGX ARGX ATNX MRSN IOVA ARPO DCPH AUTL LQDA ARVN ALLO MRKR GOSS HARP NXTC GMAB IPHA CRDF News Biotech Penny Stocks Offerings FDA Top Stories Pre-Market Outlook Trading Ideas Benzinga Fri, 29 May 2020 11:22:24 +0000 Shanthi Rexaline 16136395 at https://www.benzinga.com PhaseBio Analyst Says Coronavirus Study Creates Near-Term Catalyst https://www.benzinga.com/analyst-ratings/analyst-color/20/05/16127486/phasebio-analyst-says-coronavirus-study-creates-near-term-catalyst <p><strong>PhaseBio Pharmaceuticals Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/phas#NASDAQ">PHAS</a>) <a href="https://www.benzinga.com/news/20/05/16125834/28-stocks-moving-in-thursdays-pre-market-session"> shares </a>were&nbsp;skyrocketing Thursday after the company revealed it has received the go-ahead from the FDA for evaluating one of its lead assets for COVID-19 in clinics.</p> <h3>The PhaseBio Analyst</h3> <p>Stifel analyst <a href="https://www.tipranks.com/analysts/adam-walsh">Adam Walsh</a> has a Buy rating on PhaseBio with a&nbsp;$14 price target, suggesting over 200% upside potential.&nbsp;</p> <h3>The PhaseBio Thesis</h3> <p>There is rationale in the planned study given PB1046&#39;s MOA, and preclinical studies showing inhibition of cytokinine-mediated inflammatory responses with a vasoactive intestinal peptide, Walsh said in a Wednesday note. (See his track record <a href="https://www.tipranks.com/analysts/adam-walsh">here</a>.)</p> <p>The study of PB1046 in hospitalized COVID-19 patients at high ...</p><p><a href=https://www.benzinga.com/analyst-ratings/analyst-color/20/05/16127486/phasebio-analyst-says-coronavirus-study-creates-near-term-catalyst alt=PhaseBio Analyst Says Coronavirus Study Creates Near-Term Catalyst>Full story available on Benzinga.com</a></p> Adam Walsh Analyst Color Biotech Coronavirus Covid-19 News Penny Stocks PHAS Stifel Price Target Reiteration FDA Analyst Ratings Movers Trading Ideas PHAS News Analyst Color Biotech Penny Stocks Price Target Reiteration FDA Analyst Ratings Movers Trading Ideas Benzinga Thu, 28 May 2020 15:10:40 +0000 Shanthi Rexaline 16127486 at https://www.benzinga.com The Daily Biotech Pulse: PhaseBio To Start Potential Pivotal COVID-19 Trial, Immunomedics CEO Quits, Tetraphase Receives Sweetened Offer https://www.benzinga.com/general/biotech/20/05/16125282/the-daily-biotech-pulse-phasebio-to-start-potential-pivotal-covid-19-trial-immunomedics-ceo-quits <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 27)</p> <ul> <li><strong>ADC Therapeutics SA </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/adct#NYSE">ADCT</a>) (went public&nbsp;May 15)</li> <li><strong>Aeglea Bio Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/agle#NASDAQ">AGLE</a>)</li> <li><strong>argenx SE &ndash; ADR </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/argx#NASDAQ">ARGX</a>)</li> <li><strong>ChemoCentryx Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ccxi#NASDAQ">CCXI</a>)</li> <li><strong>Imara Inc NASDAQ: </strong>(IMRA)</li> <li><strong>Immunovant Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/imvt#NASDAQ">IMVT</a>)</li> <li><strong>Mersana Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrsn#NASDAQ">MRSN</a>) (<a href="https://www.benzinga.com/general/biotech/20/05/16113868/the-daily-biotech-pulse-cumberlands-positive-anti-bacterial-readout-fda-nods-for-bristol-myers-as">announced </a> positive interim Phase 1 data for XMT-1536 in patients with ovarian cancer)</li> <li><strong>Vermillion, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vrml#NASDAQ">VRML</a>)</li> </ul> <h3><strong>Down In The Dumps </strong></h3> <p>(Biotech Stocks Hitting 52-week Lows May 27)</p> <ul> <li><strong>Cumberland Pharmaceuticals, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cpix#NASDAQ">CPIX</a>) (announced publication of positive data for its antibiotic in treating bacteremia and endocarditis)</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>Teligent Inc</strong> (NEW JERSEY) (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tlgt#NASDAQ">TLGT</a>)</li> </ul> <h3>Stocks In Focus</h3> <h3><strong>PhaseBio Gets FDA Nod For Potentially Pivotal Trial Of COVID-19 Treatment </strong></h3> <p><strong><strong>PhaseBio Pharmaceuticals Inc </strong></strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/phas#NASDAQ">PHAS</a>)<strong> </strong>announced FDA authorization to proceed with VANGARD, a potentially pivotal clinical trial to evaluate PB1046 as a treatment for hospitalized COVID-19 patients who are at high risk for rapid clinical deterioration and acute respiratory distress syndrome.</p> <p>PhaseBio said it expects to begin dosing patients by the end of June and report trial results late in the fourth quarter of 2020.</p> <p>The stock was jumping 54.3% to $6.82 in Thursday&#39;s premarket session.</p> <p><strong>Roche To Commence Late-Stage Study Of COVID-19 Combo Treatment Option With Gilead&#39;s Remdesivir </strong></p> <p><strong>Roche Holdings AG Basel ADR Common Stock</strong> (OTC: <a class="ticker" href="https://www.benzinga.com/stock/rhhby#OTC">RHHBY</a>) announced the initiation of a global Phase 3 study to evaluate the safety and efficacy of Actemra/RoActemra plus the investigational antiviral <a href="https://www.benzinga.com/general/biotech/20/04/15907104/gileads-remdesivir-reaches-goal-in-niaid-sponsored-coronavirus-trial"> remdesivir&nbsp;</a>versus placebo plus remdesivir in hospitalized patients with severe COVID-19 pneumonia, in collaboration with<strong> Gilead Sciences, Inc.</strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gild#NASDAQ">GILD</a>).</p> <p>Roche aid it expects to enroll patients in the study in June, with the results likely to be available in the summer.</p> <p>Separately, Roche announced European approval of a new, shorter 2-hour Ocrevus infusion time, dosed twice yearly, for relapsing or primary progressive multiple sclerosis.</p> <h3>Tetraphase Receives Sweetened Offer From Melinta After AcelRx&#39;s Revised Offer</h3> <p><strong>Tetraphase Pharmaceuticals Inc</strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ttph#NASDAQ">TTPH</a>) said ...</p><p><a href=https://www.benzinga.com/general/biotech/20/05/16125282/the-daily-biotech-pulse-phasebio-to-start-potential-pivotal-covid-19-trial-immunomedics-ceo-quits alt=The Daily Biotech Pulse: PhaseBio To Start Potential Pivotal COVID-19 Trial, Immunomedics CEO Quits, Tetraphase Receives Sweetened Offer>Full story available on Benzinga.com</a></p> ACRX ADCT ADVM AGLE ARGX ARNA ARPO BCRX Biotech CCXI Coronavirus Covid-19 CPIX Earnings GERN GILD IBB IMAB IMMU IMVT IOVA MBRX MRSN News Penny Stocks PHAS RCUS RHHBY SONN TLGT TTPH VRML XBI Offerings FDA Trading Ideas XBI US78464A8707 ADCT ARNA US0400471027 BCRX US09058V1035 GERN US3741631036 GILD US3755581036 IBB US4642875565 IMMU US4529071080 MBRX RHHBY US7711951043 CPIX US2307701092 VRML US92407M2061 ACRX US00444T1007 CCXI TTPH TLGT AGLE ADVM ARGX MRSN IOVA ARPO RCUS PHAS IMAB IMVT SONN News Earnings Biotech Penny Stocks Offerings FDA Trading Ideas Benzinga Thu, 28 May 2020 12:24:57 +0000 Shanthi Rexaline 16125282 at https://www.benzinga.com The Daily Biotech Pulse: Cumberland's Positive Anti-Bacterial Readout, FDA Nods For Bristol-Myers, Astellas https://www.benzinga.com/general/biotech/20/05/16113868/the-daily-biotech-pulse-cumberlands-positive-anti-bacterial-readout-fda-nods-for-bristol-myers-as <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><em>(Biotech Stocks Hitting 52-week Highs May 26)</em></p> <ul> <li><strong>ADC Therapeutics SA </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/adct#NYSE">ADCT</a>) (IPOed May 15)</li> <li><strong>Aeglea Bio Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/agle#NASDAQ">AGLE</a>)(announced positive one-year Phase 1/2 study and Phase 2 open-label extension study of pegzilarginase in Arginase 1 Deficiency patients)</li> <li><strong>Allogene Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/allo#NASDAQ">ALLO</a>)</li> <li><strong>Altimmune Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alt#NASDAQ">ALT</a>)</li> <li><strong>argenx SE &ndash; ADR </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/argx#NASDAQ">ARGX</a>)(<a href="https://www.benzinga.com/news/earnings/20/05/16109337/mid-afternoon-market-update-crude-oil-up-2-argenx-shares-spike-higher"> announced </a> positive top-line data from a late-stage study of efgartigimod in patients with generalized Myasthenia Gravis)</li> <li><strong>BioMarin Pharmaceutical Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bmrn#NASDAQ">BMRN</a>)(gained on sell-side comment on the company being a potential target for <strong>Sanofi SA </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sny#NASDAQ">SNY</a>)</li> <li><strong>Bio-Rad Laboratories, Inc.&nbsp;</strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/bio#NYSE">BIO</a>)</li> <li><strong>Castle Biosciences Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cstl#NASDAQ">CSTL</a>)</li> <li><strong>Catalent Inc </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/ctlt#NYSE">CTLT</a>)</li> <li><strong>ChemoCentryx Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ccxi#NASDAQ">CCXI</a>)</li> <li><strong>Corbus Pharmaceuticals Holdings Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/crbp#NASDAQ">CRBP</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>Evoke Pharma Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/evok#NASDAQ">EVOK</a>)</li> <li><strong>Fate Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/fate#NASDAQ">FATE</a>)</li> <li><strong>GENMAB A/S/S ADR </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gmab#NASDAQ">GMAB</a>)</li> <li><strong>Harpoon Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/harp#NASDAQ">HARP</a>)</li> <li><strong>Horizon Therapeutics PLC </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/hznp#NASDAQ">HZNP</a>)</li> <li><strong>Immunomedics, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/immu#NASDAQ">IMMU</a>)</li> <li><strong>Immunovant Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/imvt#NASDAQ">IMVT</a>)</li> <li><strong>Intellia Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ntla#NASDAQ">NTLA</a>)</li> <li><strong>Iovance Biotherapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/iova#NASDAQ">IOVA</a>)</li> <li><strong>Kala Pharmaceuticals Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/kala#NASDAQ">KALA</a>)(announced FDA acceptance of its regulatory filing for Eysuvis, 0.25%, to treat the signs and symptoms of dry eye disease)</li> <li><strong>Madrigal Pharmaceuticals Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mdgl#NASDAQ">MDGL</a>)</li> <li><strong>MEI Pharma Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/meip#NASDAQ">MEIP</a>)</li> <li><strong>Mersana Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrsn#NASDAQ">MRSN</a>)</li> <li><strong>Minerva Neurosciences Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/nerv#NASDAQ">NERV</a>)</li> <li><strong>Neurocrine Biosciences, Inc. </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/nbix#NASDAQ">NBIX</a>)</li> <li><strong>Ovid Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ovid#NASDAQ">OVID</a>)</li> <li><strong>Passage Bio Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/pasg#NASDAQ">PASG</a>)</li> <li><strong>PDL BioPharma Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/pdli#NASDAQ">PDLI</a>)</li> <li><strong>Prevail Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/prvl#NASDAQ">PRVL</a>)</li> <li><strong>Protara Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tara#NASDAQ">TARA</a>)(received Fast Track designation for intravenous choline chloride for the treatment of intestinal failure associated liver disease)</li> <li><strong>Qiagen NV </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/qgen#NYSE">QGEN</a>)</li> <li><strong>Seres Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mcrb#NASDAQ">MCRB</a>)</li> <li><strong>Strongbridge Biopharma plc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sbbp#NASDAQ">SBBP</a>)</li> <li><strong>TG Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tgtx#NASDAQ">TGTX</a>)</li> </ul> <h3>Down In The Dumps</h3> <p><em>(Biotech Stocks Hitting 52-week Lows May 26)</em></p> <ul> <li><strong>Conatus Pharmaceuticals Inc</strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cnat#NASDAQ">CNAT</a>)</li> <li><em>Related Link: <a href="https://www.benzinga.com/analyst-ratings/analyst-color/20/05/16105423/mercks-coronavirus-plan-of-attack-2-partnerships-m-a-deal-aimed-at-treatment-vaccin">Merck&#39;s Coronavirus Plan Of Attack: 2 Partnerships, M&amp;A Deal Aimed At Treatment, Vaccine Development</a></em></li> </ul> <h3>Stocks In Focus</h3> <h3>Cumberland Announces Publication of Positive Data For&nbsp;FDA-approved Antibiotic In Treating Bacteremia and Endocarditis</h3> <p><strong>Cumberland Pharmaceuticals, Inc. </strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cpix#NASDAQ">CPIX</a>) announced a new publication in Drugs - Real World Outcomes, detailing the positive clinical outcomes with Vibativ in treating patients with bacteremia or endocarditis.</p> <p>Vibativ has been approved by the FDA for the treatment of serious bacterial infections, including hospital-acquired and ventilator-associated bacterial pneumonia. It is also approved for complicated skin and skin structure infections.</p> <p>The stock jumped 31.92% to $4.67 in after-hours trading.</p> <h3>Bristol-Myers Squibb Opdivo/Yervoy ...</h3><p><a href=https://www.benzinga.com/general/biotech/20/05/16113868/the-daily-biotech-pulse-cumberlands-positive-anti-bacterial-readout-fda-nods-for-bristol-myers-as alt=The Daily Biotech Pulse: Cumberland&#039;s Positive Anti-Bacterial Readout, FDA Nods For Bristol-Myers, Astellas>Full story available on Benzinga.com</a></p> ADCT AGLE ALLO ALPMY ALT ARGX ATRA BIO Biotech BMRN BMY CCXI CHRS CNAT CPIX CRBP CSTL CTLT CUE Earnings EVOK FATE FBIO GMAB HARP HZNP IBB IMMU IMVT IOVA KALA MCRB MDGL MEIP MRSN NBIX NERV News NTLA NUVA NVCN NVS OPB OVID PASG PDLI Penny Stocks PRVL QGEN RDHL REGN RHHBY SBBP SNOA SNY TARA TGTX TLGT TRIB XBI ZOM Offerings FDA Top Stories Pre-Market Outlook Trading Ideas XBI US78464A8707 ADCT BMRN US09061G1013 IBB US4642875565 IMMU US4529071080 NBIX US64125C1099 NUVA US6707041058 PDLI US69329Y1047 QGEN NL0000240000 REGN US75886F1075 TRIB US8964383066 BIO US0905722072 BMY US1101221083 NVS US66987V1098 SNY US80105N1054 RHHBY US7711951043 CPIX US2307701092 HZNP ALPMY ALT CCXI MEIP TGTX CNAT RDHL EVOK FATE OPB CTLT NERV ATRA CHRS NVCN CRBP MCRB FBIO SBBP TLGT AGLE NTLA MDGL SNOA ZOM OVID ARGX MRSN IOVA KALA CUE ALLO HARP PRVL GMAB CSTL IMVT TARA PASG News Earnings Biotech Penny Stocks Offerings FDA Top Stories Pre-Market Outlook Trading Ideas Benzinga Wed, 27 May 2020 11:25:23 +0000 Shanthi Rexaline 16113868 at https://www.benzinga.com Why Shares Of Women's Health-Focused Biopharma Evofem Are Rallying https://www.benzinga.com/general/biotech/20/05/16106601/why-shares-of-womens-health-focused-biopharma-evofem-are-rallying <p><strong>Evofem Biosciences Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/evfm#NASDAQ">EVFM</a>) shares gap-opened higher Tuesday morning after a binary event panned out in the company&#39;s favor.&nbsp;</p> <h3>FDA Greenlights Evofem&#39;s Contraceptive Gel</h3> <p>The San Diego, California-based biopharma, which focuses on therapies to address unmet needs in women&#39;s sexual and reproductive health, said late Friday the FDA approved Phexxi vaginal gel for the prevention of pregnancy as an on-demand method of contraception.</p> <p>Phexxi is a vaginal pH regulator contraceptive designed to maintain vaginal pH within the normal range of 3.5 to 4.5 &mdash;&nbsp;an acidic environment that is inhospitable to sperm.</p> <h3>What It Means For Evofem</h3> <p>The company faced an earlier FDA rejection in April 2016. ...</p><p><a href=https://www.benzinga.com/general/biotech/20/05/16106601/why-shares-of-womens-health-focused-biopharma-evofem-are-rallying alt=Why Shares Of Women&#039;s Health-Focused Biopharma Evofem Are Rallying>Full story available on Benzinga.com</a></p> Biotech EVFM News Oppenheimer Phexxi women's health FDA Movers Trading Ideas EVFM News Biotech FDA Movers Trading Ideas Benzinga Tue, 26 May 2020 15:32:57 +0000 Shanthi Rexaline 16106601 at https://www.benzinga.com MDMA-Assisted Therapy For PTSD Likely To Get FDA Approval By 2022 https://www.benzinga.com/markets/cannabis/20/05/16096339/mdma-assisted-therapy-for-ptsd-likely-to-get-fda-approval-by-2022 <p>By T<a href="https://thefreshtoast.com/news/legal-mdma-assisted-therapy-for-ptsd-is-likely-by-2022/">he Fresh Toast</a>&#39;s Brendan Bures, provided exclusively to <a href="http://www.benzinga.com/cannabis/">Benzinga Cannabis</a>.</p> <h3>MDMA-assisted psychotherapy is expected to receive FDA approval by 2022, following successful Phase 3 trials.</h3> <p>The Food and Drug Administration (FDA) tapped MDMA&nbsp;as a &ldquo;breakthrough therapy&rdquo;&nbsp;to treat post-traumatic stress disorder three years ago. This was seen as monumental because, like cannabis, MDMA is classified&nbsp;as a Schedule I drug&nbsp;by the Drug Enforcement Agency (DEA). That designation is given to drugs &ldquo;with no currently accepted medical use and a high potential for abuse.&rdquo;</p> <p>Fast forward to the present day and the Multidisciplinary Association for Psychedelic Studies (MAPS), the organization behind the MDMA research, is experiencing rapid success with their Phase 3 clinical trials examining how MDMA can treat PTSD. According to MAPS founder Rick Doblin, the FDA is set to approve MDMA-assisted therapy for PTSD by 2022. The organization believes such treatment will become widely available the following year.</p> <p>To be clear, this research doesn&rsquo;t mean dropping MDMA acts ...</p><p><a href=https://www.benzinga.com/markets/cannabis/20/05/16096339/mdma-assisted-therapy-for-ptsd-likely-to-get-fda-approval-by-2022 alt=MDMA-Assisted Therapy For PTSD Likely To Get FDA Approval By 2022>Full story available on Benzinga.com</a></p> 2022 Cannabis MDMA News FDA Markets News Cannabis FDA Markets Benzinga Mon, 25 May 2020 15:00:04 +0000 The Fresh Toast 16096339 at https://www.benzinga.com The Week Ahead In Biotech: ASCO Presentations In The Spotlight https://www.benzinga.com/general/biotech/20/05/16097022/the-week-ahead-in-biotech-asco-presentations-in-the-spotlight <p>Biotech stocks closed the week ended May 22 higher, with stray clinical readouts and COVID-19 drug- and vaccine-related news moving stocks in the sector.</p> <p><strong>Surface Oncology Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/surf#NASDAQ">SURF</a>) was one of the biggest advancers of the week after it <a href="https://www.benzinga.com/general/biotech/20/05/16076354/why-surface-oncologys-stock-is-surging-higher"> announced </a> an oncology partnership with <strong>Merck &amp; Co., Inc. </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/mrk#NYSE">MRK</a>).</p> <p><strong>Sorrento Therapeutics Inc </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/srne#NASDAQ">SRNE</a>), which announced on May 15 the&nbsp;discovery of&nbsp;100%&nbsp; inhibition of SARS-CoV-2, was in the news yet again this week as <a href="https://www.benzinga.com/general/biotech/20/05/16076146/short-sellers-challenge-sorrentos-announcement-of-100-coronavirus-inhibition-manipulative-at-the-"> short sellers </a> clamped down on the biotech, questioning the veracity of its claims.</p> <p><strong>AstraZeneca plc </strong>(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/azn#NYSE">AZN</a>) and Merck received the FDA nod for Lynparza to treat metastatic castration-resistant prostate cancer&nbsp;with homologous recombination repair mutations.</p> <p>The following are key catalysts for&nbsp;the unfolding week:</p> <h3>Conferences</h3> <p>2020 International Society of Cell and Gene Therapy, or ISCT, annual meeting: May 28-29.<br /> American Society of Clinical Oncologists 2020 Virtual Scientific Program: May 29-31.&nbsp;<br /> American Society for Clinical Pathology, or ASCP, 2020 Annual Meeting (virtual conference): May 29-30.&nbsp;</p> <h3>PDUFA Dates</h3> <p><strong>Regeneron Pharmaceuticals Inc (</strong>NASDAQ: REGN) and <strong>Sanofi SA </strong>(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sny#NASDAQ">SNY</a>) await the FDA verdict on their sBLA for Dupixent in pediatric eczema. (Tuesday)</p> <h3>Clinical Readouts</h3> <p><strong>Mersana Therapeutics Inc</strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrsn#NASDAQ">MRSN</a>) will present interim data from the ongoing XMT-1536 Phase 1 dose expansion in patients with ovarian cancer and non-small cell lung adenocarcinoma.</p> <p><em>See also: <a href="https://www.benzinga.com/analyst-ratings/analyst-color/20/05/16056298/these-6-coronavirus-vaccine-candidates-are-the-likeliest-to-succeed-says-morgan-sta"> These 6 Coronavirus Vaccine Candidates Are The Likeliest To Succeed, Says Morgan Stanley </a></em></p> <h3>ASCO Presentations</h3> <p><strong><strong><strong>Friday </strong></strong></strong></p> <ul> <li><strong>Arvinas Inc</strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/arvn#NASDAQ">ARVN</a>): additional Phase 1 data on ARV-110 in castration-resistant prostate cancer</li> <li><strong>Trillium Therapeutics Inc</strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tril#NASDAQ">TRIL</a>): updated Phase 1a/b data on TTI-622 in refractory lymphoma or multiple myeloma</li> <li><strong>Cardiff Oncology Inc</strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/crdf#NASDAQ">CRDF</a>): Phase 1b/2 data on onvansertib, folfiri and avastin in KRAS-mutated colorectal cancer</li> <li><strong>Iovance Biotherapeutics Inc</strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/iova#NASDAQ">IOVA</a>): new interim Phase 2 data on LN-144-lifileucel in refractory metastatic melanoma</li> <li><strong>Blueprint Medicines Corp</strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bpmc#NASDAQ">BPMC</a>): updated Phase 1/2 data for praksetinib in RET-altered tumors</li> <li><strong>Allogene Therapeutics Inc</strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/allo#NASDAQ">ALLO</a>): Initial Phase 1 data for ALLO-501 in non-Hodgkin lymphoma</li> <li><strong>Deciphera Pharmaceuticals Inc</strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/dcph#NASDAQ">DCPH</a>): Phase 1b/2 ...</li></ul><p><a href=https://www.benzinga.com/general/biotech/20/05/16097022/the-week-ahead-in-biotech-asco-presentations-in-the-spotlight alt=The Week Ahead In Biotech: ASCO Presentations In The Spotlight>Full story available on Benzinga.com</a></p> ADAP ADVM AGIO ALLO Biotech BPMC Coronavirus Covid-19 CRDF CRVS CTMX CYAD DCPH DMPI GERN GMAB GNCA GOSS HARP HTBX IBB IMGN IMMP IMMU IMV INO IOVA IPHA KRTX KURA LYRA MEIP MESO MGNX MRK MRKR MRSN MRUS News NXTC ONCT ONCY Penny Stocks PFE RDHL REGN RHHBY SBPH SLRX SNY SRNE SURF TRIB TRIL XBI XNCR ZIOP Health Care Previews FDA Trading Ideas General INO US45773H1023 XBI US78464A8707 GERN US3741631036 IBB US4642875565 IMGN US45253H1014 IMMU US4529071080 ONCY CA6823101077 REGN US75886F1075 TRIB US8964383066 ZIOP US98973P1012 MRK US58933Y1055 PFE US7170811035 SNY US80105N1054 RHHBY US7711951043 MEIP ONCT SLRX IMMP SURF IMV HTBX AGIO RDHL MGNX GNCA XNCR DMPI SRNE TRIL ADAP BPMC CYAD CTMX MRUS MESO KURA CRVS SBPH ADVM MRSN IOVA DCPH ALLO MRKR GOSS HARP NXTC GMAB KRTX IPHA LYRA CRDF News Biotech Penny Stocks Health Care Previews FDA Trading Ideas General Benzinga Sun, 24 May 2020 18:40:41 +0000 Shanthi Rexaline 16097022 at https://www.benzinga.com