Biotech en Immune Design Presents Data on the Mechanism of Action of G100 via TLR4 Expressed in B Cell Malignancies at the Inaugural AACR International Meeting Advances in Malignant Lymphoma <link type="text/css" rel="stylesheet" href="" /> <p align="center"><em>- G100 directly targets and modifies TLR4 expressing malignant B cells making them more visible to the anti-tumor immune response-</em><br /></p> <p align="justify">SEATTLE and SOUTH SAN FRANCISCO, Calif., June 25, 2018 (GLOBE NEWSWIRE) -- <a href="" rel="nofollow" target="_blank" rel="nofollow">Immune Design</a> (NASDAQ:<a class="ticker" href="" rel="nofollow">IMDZ</a>), an immunotherapy company focused on novel therapies in oncology, today announced preclinical and translational data that support the mechanism of action of G100 in patients with indolent non-Hodgkin Follicular lymphomas (FL). These data were presented at the Inaugural AACR International Meeting Advances in Malignant Lymphoma: Maximizing the Basic-Translational Interface for Clinical Application 2018 in Boston.</p> <p align="justify">The research presented was designed to understand why high TLR 4 expression in patient&#039;s samples correlated with clinical responses to G100 treatment. By analyzing patient samples, cell lines and mouse lymphoma models the following was observed:</p> <ul type="disc"> <li>Murine and human B-lymphoma cell lines express TLR4 and respond <em>in vitro</em> to G100 stimulation with upregulation of MHC-II and co-stimulatory markers CD40 and CD80, typical of the activation of antigen-presenting function of B-cells;</li> <li><em>In vivo</em> murine tumors of lymphoma models respond to treatment with G100 in injected tumors as well as distal, untreated tumors showing local and abscopal tumor control, mediated by systemic T-cell response;</li> <li>Approximately 70% of follicular lymphoma patients in a Phase 1/2 study express TLR4 in &gt;50% of tumor cells in baseline biopsies. TLR4 expression ranging from 10%-100% of tumor cells was also detected in biopsies of patients with marginal zone lymphoma, small lymphocytic lymphoma, diffuse large B-cell lymphoma and cutaneous T-cell lymphoma; and</li> <li>In an ongoing Phase 2 trial of G100 with low dose radiation and pembrolizumab, almost all patients with an objective tumor response (³50% tumor shrinkage) showed TLR4 expression in &gt;50% of tumor cells.</li> </ul> <p align="justify">"These data illustrate that in addition to the known activation by G100 of dendritic cells and macrophages in the tumor microenvironment, G100 can ...</p><p><a href= alt=Immune Design Presents Data on the Mechanism of Action of G100 via TLR4 Expressed in B Cell Malignancies at the Inaugural AACR International Meeting Advances in Malignant Lymphoma>Full story available on</a></p> Biotech IMDZ Press Releases General IMDZ Biotech Press Releases General Benzinga Mon, 25 Jun 2018 12:00:00 +0000 Globe Newswire 11927075 at MaRS Innovation appoints Steven Chackowicz as Executive-in-Residence <link type="text/css" rel="stylesheet" href="" /> <p>Toronto, ON, June 25, 2018 (GLOBE NEWSWIRE) -- MaRS innovation (MI) announced today that Steven Chackowicz has been appointed Executive-in-Residence where he will oversee the technology scouting and commercialization efforts for MI in the medical device space. </p> <table border="0"> <tr> <td> <table width="201" cellspacing="6" class="gnw_news_media_box" cellpadding="1" border="0"> <tr> <td class="gnw_media_bgcolor"> <table width="100%" align="center" border="0" cellspacing="0" cellpadding="0"> <tr> <td colspan="2"><a href="" rel="nofollow"><img src="" border="0" width="196" height="19" alt="0_int_MARS.jpg" /></a></td> </tr> </table> </td> </tr> </table> <p> <br /><br /> </p></td> </tr> </table> <p>Steven Checkowicz is an experienced technology executive. A serial entrepreneur in early-stage companies, he defined and executed strategies and tactics that enabled newly formed companies to move to significant commercial success.  Steven has been successful in assisting companies toward positive liquidity events by driving revenue growth and new product adoption ...</p><p><a href= alt=MaRS Innovation appoints Steven Chackowicz as Executive-in-Residence>Full story available on</a></p> Biotech News Management Press Releases General News Biotech Management Press Releases General Benzinga Mon, 25 Jun 2018 12:00:00 +0000 Globe Newswire 11927019 at BioCryst Reports Agreement with PMDA on Phase 3 Clinical Trial and Regulatory Requirements for Marketing Authorization of BCX7353 in Japan <link type="text/css" rel="stylesheet" href="" /> <p align="justify"><em>BCX7353 continues development under Sakigake designation</em></p> <p align="justify">RESEARCH TRIANGLE PARK, N.C., June 25, 2018 (GLOBE NEWSWIRE) --  <a href="" rel="nofollow" target="_blank" rel="nofollow">BioCryst Pharmaceuticals, Inc.</a> (NASDAQ:<a class="ticker" href="" rel="nofollow">BCRX</a>), a pharmaceutical company focused on the development and commercialization of treatments for rare diseases, today announced that the Company has reached agreement on the design of a Phase 3 trial and regulatory requirements for marketing authorization of BCX7353 for Hereditary Angioedema ("HAE") with the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan.<br /></p> <p align="justify">The Phase 3 trial design agreed upon for Japan, APeX-J, is a randomized, placebo-controlled double-blind trial of 24 weeks duration with a 28-week safety extension. Approximately 24 Japanese subjects with HAE will be enrolled. The APeX-J trial design closely follows the design of APeX-2, a Phase 3 clinical trial being conducted in the U.S., Canada and European countries. APeX-J tests the same dose levels of BCX7353 as in APeX-2, 110 mg daily and 150 mg daily, and the endpoints are identical to those in APeX-2. Data from the APeX-J and APeX-2 trials will be combined for regulatory submission in Japan.</p> <p align="justify">"Japanese HAE patients would welcome an oral prophylactic drug as another treatment alternative, which provides HAE patients ease in daily life as well as relief from travelling outside their home town for treatment to receive on-demand therapy of HAE attacks in a hospital," said Professor Michihiro Hide, M.D., Ph.D, Dean of the School of Medicine and Professor and Chairman, Department of Dermatology, Hiroshima University, and a leading expert in HAE in Japan.</p> <p align="justify">BCX7353 was one of the first products granted Sakigake designation by the Japanese PMDA in October 2015. Sakigake ...</p><p><a href= alt=BioCryst Reports Agreement with PMDA on Phase 3 Clinical Trial and Regulatory Requirements for Marketing Authorization of BCX7353 in Japan>Full story available on</a></p> BCRX Biotech Health Care Retail Sales Press Releases General BCRX US09058V1035 Biotech Health Care Retail Sales Press Releases General Benzinga Mon, 25 Jun 2018 10:00:00 +0000 Globe Newswire 11926161 at The Week Ahead In Biotech: Conferences, Clinical Trials And IPOs <p>Biotech stocks saw some upward momentum last week. The defensive nature of biotech stocks drove investors into the space amid a rise in risk aversion following the ongoing U.S.-China trade war. The week also saw a slew of initial public offerings.</p> <p>Looking ahead, here are the catalytic events in the unfolding week a biotech investor needs to be mindful about.</p> <h3>Conferences</h3> <ul> <li>6th Global Congress on Prostate Cancer &ndash; June 28-30 in Frankfurt, Germany.</li> <li>60th Annual Scientific Meeting of the American Headache Society (AHS) &ndash; June 28-July 1, in San Francisco, California.</li> </ul> <h3><strong>Drugs To Watch</strong></h3> <p><strong>Monday, June 25</strong></p> <p><strong>Achaogen Inc </strong> (NASDAQ: <a class="ticker" href="">AKAO</a>) awaits FDA verdict on its <a href="">plazomicin</a> to treat complicated urinary tract infections (cUTI) and bloodstream infections (BSI).</p> <p><strong>Wednesday, June 27 </strong></p> <p>The FDA is set to rule on <strong> GW Pharmaceuticals PLC- ADR </strong> (NASDAQ: <a class="ticker" href="">GWPH</a>)&#39;s epidiolex, which is being evaluated as an adjunctive treatment of seizures, with Lennox-Gastaut syndrome (LGS) and Dravet. FDA&#39;s Peripheral and Central Nervous System Drugs Advisory Committee, which met in April, unanimously recommended approval, of <a href="">epidiolex</a>.</p> <p><strong>Saturday, June 30 </strong></p> <p>The FDA is due to announce its decision on <strong> Dermira Inc </strong> (NASDAQ: ...</p><p><a href= alt=The Week Ahead In Biotech: Conferences, Clinical Trials And IPOs>Full story available on</a></p> AKAO ALDR ALKS APLS ARRY ASNS Biotech DERM DRRX GWPH IBB News PTIE Previews FDA IPOs Top Stories Trading Ideas ALKS IE00B56GVS15 ARRY US04269X1054 DRRX US2666051048 IBB US4642875565 PTIE US69562K1007 GWPH AKAO ALDR DERM APLS ASNS News Biotech Previews FDA IPOs Top Stories Trading Ideas Benzinga Sun, 24 Jun 2018 14:43:41 +0000 Shanthi Rexaline 11916198 at Evercore ISI Says Bluebird Bio Has Path To Commercialization, Madrigal Pharma Outpaced By Mid-Cap Alternatives <p>Shares of <strong>bluebird bio Inc</strong> (NASDAQ: <a class="ticker" href="">BLUE</a>) &mdash;&nbsp;a clinical-stage biopharmaceutical company focused on bringing to market advanced products based on the potential of gene therapy &mdash; have been highly volatile, but the company has a &quot;clear path&quot; toward commercialization, according to Evercore ISI.</p> <h3>The Analyst</h3> <p>Evercore ISI&#39;s Josh Schimmer on June 19 upgraded <a href="">bluebird</a> from In-line to Outperform with a price target lifted from $175 to $230.</p> <p>The analyst downgraded <strong>Madrigal Pharmaceuticals Inc</strong> (NASDAQ: <a class="ticker" href="">MDGL</a>) from Outperform to In-Line with an unchanged $300 price target.</p> <h3>Bluebird&#39;s March Toward Commercialization</h3> <p>Bluebird&#39;s recent updates related to its LentiGlobin investigational gene therapy in patients with sickle cell disease and the separate myeloma CAR-T therapy bb2121 with its partner&nbsp;<strong>Celgene Corporation</strong> (NASDAQ: <a class="ticker" href="">CELG</a>) represent an &quot;important positive inflection&quot; for the company, Schimmer said in the upgrade note.</p> <p>Granted, there are still &quot;existential ...</p><p><a href= alt=Evercore ISI Says Bluebird Bio Has Path To Commercialization, Madrigal Pharma Outpaced By Mid-Cap Alternatives>Full story available on</a></p> Analyst Color bb2121 Biotech BLUE CELG Evercore ISI gene therapy Josh Schimmer LentiGlobin MDGL Upgrades Downgrades Price Target Analyst Ratings General CELG US1510201049 BLUE MDGL Analyst Color Biotech Upgrades Downgrades Price Target Analyst Ratings General Benzinga Sat, 23 Jun 2018 14:21:42 +0000 Jayson Derrick 11902623 at Pot Stocks, ETFs, Top News And Data From The Cannabis Industry This Week <p>This was a huge week for the marijuana industry: Canada became the second country in the world to legalize cannabis for recreational uses.</p> <p>&ldquo;October 17 was set as the first day for recreational sales. Some people in the industry wanted an earlier date, but at least companies can now make plans for a specific date,&rdquo; Debra Borchardt, CEO of Green Market Report told Benzinga.</p> <p>Other experts&nbsp;<a href="">highlighted the impact of Canada&rsquo;s move on the international realm</a>. Jeff Siegel, managing editor of Green Chip Stocks, singled out a few stocks he believes &ldquo;are going to continue to see a flood of capital coming in&hellip;. much of which was previously flooding into Canada.&rdquo;</p> <p>&ldquo;The other big news was that <strong>Tilray</strong> filed for an IPO on the NASDAQ,&rdquo; Borchardt said. &ldquo;The company reported solid financial numbers, and that will make this a sought-after offering among cannabis investors. Tilray will be a &lsquo;controlled company&rsquo; since Privateer Holdings will have the majority voting power.&quot;</p> <p>In addition, <strong>High Times</strong>&nbsp;announced its crowdfunding campaign and RegA+ IPO. Investors are now able to purchase shares of the 44-year-old media and entertainment company before its planned Nasdaq stock market listing later this year. This comes after the company announced that it is adding former President of Mexico, Vicente Fox Quesada, to its board.</p> <p><em>Related Link: <a href="">Former Mexican President Vicente Fox Talks NAFTA, Trump And Regulated Marijuana Trade</a></em></p> <p>&ldquo;The company is only weeks away from publicly listing on the Nasdaq, just weeks after organizing America&#39;s first state-sanctioned recreational cannabis event in Sacramento,&rdquo; Fox told Benzinga. &ldquo;This is an enormous opportunity for the general populous to buy into the growing green rush, and they&#39;re just getting started.&rdquo;</p> <p>See details of the IPO below:</p> <p><img alt="" src="" style="height:329px; width:600px" /></p> <p><em>Source: High Times.</em></p> <p>Despite the news, the <strong>United States Marijuana Index, </strong>which tracks 17 of the largest marijuana stocks in the U.S., lost 3.7 percent this week, while the <strong>North American Marijuana Index</strong>, which also includes Canadian stocks, tumbled less than 1 percent.</p> <p>Over the last five trading days, the <strong>Horizons Marijuana Life Sciences Index ETF</strong> (OTC: <a class="ticker" href="">HMLSF</a>) (TSE:HMMJ) gained 7.3 percent, while the <strong>ETFMG Alternative Harvest ETF </strong>(NYSE: <a class="ticker" href="">MJ</a>) rose almost 4 percent &ndash; and started trading ex-dividend. The <strong>SPDR S&amp;P 500 ETF Trust </strong>(NYSE: <a class="ticker" href="">SPY</a>) was down 0.7 percent.</p> <h3><strong>Stock Moves</strong></h3> <p>Here are some of the top marijuana stocks in U.S. exchanges and how the performed over the last five trading days:</p> <ul> <li><strong>22nd Century Group Inc </strong>(NYSE: <a class="ticker" href="">XXII</a>): up 10.3 percent</li> <li><strong>Aphria Inc </strong>(OTC: <a class="ticker" href="">APHQF</a>): up 8.2 percent</li> <li><strong>Aurora Cannabis Inc </strong>(OTC: <a class="ticker" href="">ACBFF</a>): up 10.45 percent</li> <li><strong>Cannabis Sativa Inc </strong>(OTC: <a class="ticker" href="">CBDS</a>): up 1 percent</li> <li><strong>CannTrust Holdings Inc </strong>(OTC: <a class="ticker" href="">CNTTF</a>): up 7.6 percent</li> <li><strong>Canopy Growth Corp </strong>(NYSE: <a class="ticker" href="">CGC</a>): up 10.2 percent</li> <li><strong>Cronos Group Inc. </strong>(NASDAQ: <a class="ticker" href="">CRON</a>): up 2.85 percent</li> <li><strong>GW Pharmaceuticals PLC- ADR </strong>(NASDAQ: <a class="ticker" href="">GWPH</a>): up 3.1 percent</li> <li><strong>Hiku Brands Company Ltd</strong> (OTC: <a class="ticker" href="">DJACF</a>): up 19.4 percent</li> <li><strong>India Globalization Capital, Inc. </strong>(NYSE: <a class="ticker" href="">IGC</a>): down 1.6 percent</li> <li><strong>iAnthus Capital Holdings Inc </strong>(OTC: <a class="ticker" href="">ITHUF</a>): up 13.15 percent</li> <li><strong>MassRoots Inc </strong>(OTC: <a class="ticker" href="">MSRT</a>): up 0.1 percent</li> <li><strong>MedReleaf Corp</strong> (OTC: <a class="ticker" href="">MEDFF</a>): up 18 percent</li> <li><strong>Scotts Miracle-Gro Co </strong>(NYSE: <a class="ticker" href="">SMG</a>): down 5 percent</li> <li><strong>THC Biomed Intl Ltd </strong>(OTC: <a class="ticker" href="">THCBF</a>): up 11.8 percent</li> <li><strong>Zynerba Pharmaceuticals Inc </strong>(NASDAQ: <a class="ticker" href="">ZYNE</a>): down 2.7 percent</li> </ul> <h3><strong>In Other News</strong></h3> <p>A consortium of cannabis-related media professionals are conducting a <strong>Cannabis Media Survey.</strong> You can answer following <a href="">this link</a>.</p> <p><strong>Cronos Group</strong> announced its subsidiary Cronos Australia was granted a medicinal cannabis Manufacture License by the Australian Office of Drug Control. This license allows the company to manufacture cannabinoid-based products in Australia, extracting, refining, concentrating and transforming the cannabis plant.</p> <p><strong>Tidal Royalty Corporation</strong><strong>,</strong> a provider of ...</p><p><a href= alt=Pot Stocks, ETFs, Top News And Data From The Cannabis Industry This Week>Full story available on</a></p> ACBFF APHQF BDS Analytics Biotech BrewBudz Canada Canada Cannabis Canada Marijuana Cannabiniers Cannabis Cannabis ETF cannabis news Cannabis Stock Index cannabis stocks Canndescent CBDS CGC Civilized CNTTF COWN CRON Cy Scott Debra Borchardt Derek Riedle DJACF Green Market Report GreenWave GWPH H Headset High Times HMLSF HSTRF HYYDF IGC IIPR invest in marijuana ITHUF Jeff Harris Jeff Siegel Larisa Bolivar Long Ideas marijuana Marijuana ETF Marijuana Index Marijuana Money marijuana news marijuana stocks Mazakali MEDFF Michigan cannabis Michigan Marijuana MJ MJNA MSRT New Frontier Data News North American Marijuana Index ONE Cannabis Paul Rosen Postmedia Pot Stocks PRMCF Ricardo Baca Sector ETFs SMG SPY Stuart Titus Sumit Mehta THCBF The Fresh Toast The+Source TheGrowthOp Tidal Royalty Tilray TRTC United States Marijuana Index Vicente Fox Vivien Azer XXII ZYNE Emerging Markets Specialty ETFs Health Care Emerging Market ETFs Politics M&A IPOs Top Stories Markets Movers Trading Ideas Interview ETFs General IGC US45408X1000 SPY US78462F1030 COWN US2236221014 SMG US8101861065 H US4485791028 CGC MJNA US58463A1051 TRTC ITHUF XXII CNTTF HSTRF GWPH CBDS MSRT ZYNE THCBF ACBFF APHQF MJ PRMCF IIPR DJACF HYYDF MEDFF HMLSF CRON Long Ideas Sector ETFs News Biotech Specialty ETFs Emerging Markets Health Care Emerging Market ETFs Politics M&A IPOs Top Stories Markets Movers Trading Ideas Interview ETFs General Benzinga Fri, 22 Jun 2018 20:20:50 +0000 Javier Hasse 11923319 at Achaogen In The Spotlight Ahead of FDA Verdict On Plazomicin <p><strong>Achaogen Inc </strong>(NASDAQ: <a class="ticker" href="">AKAO</a>) shares have been rangebound between $10 and $14 since late last year, with a mixed FDA panel vote on its antibiotic treatment candidate plazomicin in early May stifling any potential rally.</p> <h3>A Plazomicin Primer</h3> <p>Plazomicin is Achaogen&#39;s lead product candidate. It is a semisynthetic aminoglycoside antibiotic being developed for infections due to multidrug-resistant Enterobacteriaceae, especially carbapenem-resistant Enterobacteriaceae, or CRE.</p> <p>CRE, though relatively rate, spreads very quickly and is resistant to existing antibiotics.</p> <h3>The Development History</h3> <p><a href="">Achaogen </a> submitted a new drug application for plazomicin to the FDA in October&nbsp;2017 for treating complicated urinary tract infections, or cUTIs, including polynephritis and blood stream infections. The FDA accepted the application in December and accorded it priority review status, rendering a PDUFA date of June 25 &mdash; six months from the acceptance of the application as opposed to the standard review period of 10 months.&nbsp;</p> <p>The FDA has also granted plazomicin breakthrough therapy designation for treating BSI caused by certain Enterobacteriaceae.</p> <p>Incidentally, the pipeline candidate received fast track designation for treating life-threatening CRE.</p> <p>The NDA submission was based on two late-stage Phase 3&nbsp;studies, dubbed the EPIC and CARE trials.</p> <p>In December, Achaogen released the results of the two trials. The EPIC study, which ...</p><p><a href= alt=Achaogen In The Spotlight Ahead of FDA Verdict On Plazomicin>Full story available on</a></p> AKAO Biotech Edward Nash News SunTrust Robinson Humphrey FDA Trading Ideas AKAO News Biotech FDA Trading Ideas Benzinga Fri, 22 Jun 2018 20:16:10 +0000 Shanthi Rexaline 11915315 at Benzinga's Daily Biotech Pulse: FDA Greenlights Tandem Diabetes' Insulin Pump, More IPOs On Tap <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>(Stocks hitting 52-week highs on June 21)</em></p> <ul> <li><strong>Aerie Pharmaceuticals Inc </strong> (NASDAQ: <a class="ticker" href="">AERI</a>)</li> <li><strong>FibroGen Inc </strong> (NASDAQ: <a class="ticker" href="">FGEN</a>)</li> <li><strong>Heron Therapeutics Inc </strong> (NASDAQ: <a class="ticker" href="">HRTX</a>)(announced its pain treatment candidate HTX-011 received Breakthrough Therapy designation from the FDA)</li> <li><strong>Myovant Sciences Ltd </strong> (NYSE: <a class="ticker" href="">MYOV</a>)</li> <li><strong>NeoGenomics, Inc. </strong> (NASDAQ: <a class="ticker" href="">NEO</a>)</li> </ul> <h3>Down In The Dumps</h3> <p><em>(Stocks hitting 52-week lows on June 21)</em></p> <ul> <li><strong>Agenus Inc </strong> (NASDAQ: <a class="ticker" href="">AGEN</a>)</li> <li><strong>Auris Medical Holding AG </strong> (NASDAQ: <a class="ticker" href="">EARS</a>)</li> <li><strong>Celldex Therapeutics, Inc. </strong> (NASDAQ: <a class="ticker" href="">CLDX</a>)</li> <li><strong>Cellectar Biosciences Inc </strong> (NASDAQ: <a class="ticker" href="">CLRB</a>)</li> <li><strong>DelMar Pharmaceuticals Inc </strong> (NASDAQ: <a class="ticker" href="">DMPI</a>)</li> <li><strong>Enzo Biochem, Inc. </strong> (NYSE: <a class="ticker" href="">ENZ</a>)</li> <li><strong>Immune Pharmaceuticals Inc </strong> (NASDAQ: <a class="ticker" href="">IMNP</a>)</li> <li><strong>MeiraGTx Holdings PLC </strong> (NASDAQ: <a class="ticker" href="">MGTX</a>)</li> <li><strong>Mustang Bio Inc </strong> (NASDAQ: <a class="ticker" href="">MBIO</a>)</li> <li><strong>Nabriva Therapeutics PLC &ndash; ADR </strong> (NASDAQ: <a class="ticker" href="">NBRV</a>)</li> <li><strong>Oncobiologics Inc </strong> (NASDAQ: <a class="ticker" href="">ONS</a>)</li> <li><strong>Opiant Pharmaceuticals Inc </strong> (NASDAQ: <a class="ticker" href="">OPNT</a>)</li> <li><strong>Reshape Lifesciences Inc </strong> (NASDAQ: <a class="ticker" href="">RSLS</a>)</li> <li><strong>Soligenix, ...</strong></li></ul><p><a href= alt=Benzinga&#039;s Daily Biotech Pulse: FDA Greenlights Tandem Diabetes&#039; Insulin Pump, More IPOs On Tap>Full story available on</a></p> AERI AGEN AUTL Biotech BMY CLDX CLRB DMPI EARS ECOR ENZ FGEN HRTX IBB IMNP MBIO MDT MGTX MYOV NBRV NEO News ONS OPNT RSLS SNGX TNDM ZIOP FDA IPOs Top Stories Pre-Market Outlook Trading Ideas AGEN US00847G7051 CLDX US15117B1035 IBB US4642875565 OPNT US6837571081 ZIOP US98973P1012 BMY US1101221083 ENZ US2941001024 MDT US5850551061 SNGX NEO AERI TNDM US64128B1089 HRTX EARS CLRB DMPI IMNP FGEN NBRV ONS MYOV MBIO RSLS AUTL MGTX ECOR News Biotech FDA IPOs Top Stories Pre-Market Outlook Trading Ideas Benzinga Fri, 22 Jun 2018 12:51:31 +0000 Shanthi Rexaline 11919278 at CytoDyn Announces Productive Pre-BLA Meeting with FDA for PRO 140 Combination Therapy <link type="text/css" rel="stylesheet" href="" /> <p align="center"><em>- Rolling BLA Submission Starting as Early as the End of 2018 </em><br /><em>- FDA Provides Guidance on Ongoing Requirements </em></p> <p>VANCOUVER, Washington, June 22, 2018 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company developing new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that it had a productive meeting with the U.S. Food and Drug Administration (FDA) regarding the Company&#039;s planned Biologics License Application (BLA).  Based on FDA feedback, the Company will continue to gather safety and efficacy data from its ongoing monotherapy HIV clinical trials to support the BLA submission.  FDA pointed to various potential review issues that the Company believes it can adequately address in the BLA. The agency agreed that the safety portion of the filings should include data from patients treated with PRO 140 and followed for a minimum of 24 weeks, which CytoDyn can accumulate from any of the Company&#039;s three ongoing HIV clinical trials, two of which are monotherapy trials.</p> <p>"Our pre-BLA meeting with the FDA was productive and provided specific guidance for meeting the FDA&#39;s requirements for a BLA" stated Nader Pourhassan, Ph.D., CytoDyn President and Chief Executive Officer, "Understanding the FDA&#039;s concerns and requirements for the BLA submission puts the Company on a solid footing to move forward with filing our first BLA for PRO 140. Our BLA filings may start as early as the end of 2018 and the FDA review process will start when the full BLA submission is completed and the FDA has accepted the BLA for review."</p> <p><strong>About PRO 140 </strong><br />PRO 140 belongs to a new class of HIV/AIDS therapeutics – viral-entry inhibitors – that is intended to protect healthy cells from viral infection. PRO 140 is a humanized IgG4 monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter T cells. PRO 140 blocks the predominant HIV (R5) subtype entry into T cells by masking this required co-receptor, CCR5. Importantly, PRO 140 does not appear to interfere with the normal function of CCR5 in mediating immune responses. PRO 140 does not have agonist activity toward CCR5 but does have antagonist activity to CCL5, which is a central mediator in inflammatory diseases. PRO 140 has been the subject of ...</p><p><a href= alt=CytoDyn Announces Productive Pre-BLA Meeting with FDA for PRO 140 Combination Therapy>Full story available on</a></p> Biotech CYDY Health Care Retail Sales Press Releases General CYDY Biotech Health Care Retail Sales Press Releases General Benzinga Fri, 22 Jun 2018 10:00:00 +0000 Globe Newswire 11919498 at Benzinga's Daily Biotech Pulse: AbbVie Launches New Pediatric Humira, IPO Deluge Hits The Street <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>(Stocks hitting 52-week highs on June 20)</em></p> <ul> <li><strong>Agios Pharmaceuticals Inc </strong> (NASDAQ: <a class="ticker" href="">AGIO</a>)(announced initiation of Phase 3 ACTIVATE study, which evaluated its AG-348 in patients with Pyruvate kinase deficiency who do not receive regular blood transfusions)</li> <li><strong>AngioDynamics, Inc. </strong> (NASDAQ: <a class="ticker" href="">ANGO</a>)</li> <li><strong>Array Biopharma Inc </strong> (NASDAQ: <a class="ticker" href="">ARRY</a>)</li> <li><strong>Audentes Therapeutics Inc </strong> (NASDAQ: <a class="ticker" href="">BOLD</a>)</li> <li><strong>AxoGen, Inc Common Stock </strong> (NASDAQ: <a class="ticker" href="">AXGN</a>)</li> <li><strong>Caladrius Biosciences Inc </strong> (NASDAQ: <a class="ticker" href="">CLBS</a>) (announced that FDA granted regenerative medicine advanced therapy designation to its late stage CD34+ cell therapy program for treating refractory angina)</li> <li><strong>Cerus Corporation </strong> (NASDAQ: <a class="ticker" href="">CERS</a>)</li> <li><strong>Coherus Biosciences Inc </strong> (NASDAQ: <a class="ticker" href="">CHRS</a>)</li> <li><strong>CONMED Corporation </strong> (NASDAQ: <a class="ticker" href="">CNMD</a>)</li> <li><strong>Glaukos Corp </strong> (NYSE: <a class="ticker" href="">GKOS</a>)</li> <li><strong>Jazz Pharmaceuticals PLC </strong> (NASDAQ: <a class="ticker" href="">JAZZ</a>)</li> <li><strong>Merus NV </strong> (NASDAQ: <a class="ticker" href="">MRUS</a>)</li> <li><strong>Mirati Therapeutics Inc </strong> (NASDAQ: <a class="ticker" href="">MRTX</a>)</li> <li><strong>MORPHOSYS AG/S ADR </strong> (NASDAQ: <a class="ticker" href="">MOR</a>)(presented at the JMP Securities Life Sciences Conference)</li> <li><strong>Myovant Sciences Ltd </strong> (NYSE: <a class="ticker" href="">MYOV</a>)</li> <li><strong>NeoGenomics, Inc. </strong> (NASDAQ: <a class="ticker" href="">NEO</a>)</li> <li><strong>Neurocrine Biosciences, </strong> (Inc. NASDAQ: NBIX)</li> <li><strong>Regenxbio Inc </strong> (NASDAQ: <a class="ticker" href="">RGNX</a>)</li> <li><strong>Ultragenyx Pharmaceutical Inc </strong> (NASDAQ: <a class="ticker" href="">RARE</a>)</li> <li><strong>Uniqure NV </strong> (NASDAQ: <a ...</li></ul><p><a href= alt=Benzinga&#039;s Daily Biotech Pulse: AbbVie Launches New Pediatric Humira, IPO Deluge Hits The Street>Full story available on</a></p> ABBV AGIO ANGO ANIK APTX ARRY AVRO AXGN Biotech BOLD CATB CERS CHRS CKPT CLBS CLRB CNMD CYTX GKOS IBB JAZZ KZR MGTA MOR MRTX MRUS MYOV NEO News NVIV QURE RARE RGNX RIGL RSLS SBOT XERS IPOs Top Stories Pre-Market Outlook Trading Ideas MOR ANGO US03475V1017 ANIK US0352551081 ARRY US04269X1054 CERS US1570851014 CNMD US2074101013 CYTX US23283K1051 IBB US4642875565 JAZZ US4721471070 RIGL US7665596034 NVIV AXGN BOLD NEO ABBV AGIO MRTX QURE RARE CLRB CHRS CLBS CATB GKOS RGNX MRUS SBOT MYOV CKPT RSLS APTX MGTA XERS KZR AVRO News Biotech IPOs Top Stories Pre-Market Outlook Trading Ideas Benzinga Thu, 21 Jun 2018 12:39:23 +0000 Shanthi Rexaline 11912379 at Onconova Therapeutics Announces Promotion for Steven M. Fruchtman, M.D. <link type="text/css" rel="stylesheet" href="" /> <ul> <li style="text-align:left;">New Role as the President involves leadership of the entire product portfolio<br /></li> <li>Promotion reflects progress of Rigosertib to key data milestones</li> </ul> <p>NEWTOWN, Pa., June 21, 2018 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ:<a class="ticker" href="" rel="nofollow">ONTX</a>), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on myelodysplastic syndromes (MDS), today announced the promotion of Dr. Steven M. Fruchtman. In his new role as President, Dr. Fruchtman will have oversight over the entire product portfolio, as well as a key role in all other areas of the Company. He will continue to maintain the responsibilities of Chief Medical Officer until a replacement is hired to assume that role. Dr. Fruchtman will continue to report to Dr. Ramesh Kumar, co-founder and Chief Executive Officer of the Company.</p> <p>Dr. Fruchtman joined Onconova as Chief Medical Officer (CMO) and Senior Vice President, Research and Development, in January 2015. He is a board certified hematologist with extensive industry experience in clinical research for myelodysplastic syndromes, hematologic malignancies and solid tumors. Prior to his transition to industry, Dr. Fruchtman served as the Director of the Myeloproliferative Disorder Program at Mt. Sinai Hospital in New York City and established the Stem Cell Transplant Program there. He has served with increasing responsibilities at Ortho Biotech, Novartis, and biotechnology companies Allos, Spectrum, and Syndax, leading to Health Authority approvals for a number of new chemical entities in various malignancies. His commitment to the areas of hematology/oncology and myeloproliferative disorders is exemplified by his service as an external reviewer for the <em>New England Journal of Medicine</em>, <em>Mayo Clinic Proceedings</em>, <em>Experimental Hematology</em>, <em>European Journal of Haematology</em>, <em>Leukemia</em>, and his role as a member of the editorial board of <em>The Mount Sinai Journal of Medicine</em>. Dr. Fruchtman is an author of more than 170 lectures, presentations, books, and chapters. He received his Bachelor of Arts with Honors from Cornell University, and his M.D. from New York Medical College. He was recently named to the Board of The Bone Marrow Foundation located in NYC.</p> <p>"Steve has an enviable track record of successful development and approval of several new drugs for the unmet needs of cancer patients. His background as a practicing hematologist/oncologist, combined with his research and development acumen and experience, position him very well to lead the development of our innovative late stage portfolio ...</p><p><a href= alt=Onconova Therapeutics Announces Promotion for Steven M. Fruchtman, M.D.>Full story available on</a></p> Biotech News ONTX Management Press Releases General ONTX News Biotech Management Press Releases General Benzinga Thu, 21 Jun 2018 12:00:00 +0000 Globe Newswire 11913551 at Top-Five National Payer Issues Positive Coverage Decision for Myriad's Prolaris® Test for Prostate Cancer <link type="text/css" rel="stylesheet" href="" /> <p align="left">SALT LAKE CITY, June 21, 2018 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:<a class="ticker" href="" rel="nofollow">MYGN</a>), a leader in molecular diagnostics and personalized medicine, today announced that it has received a positive medical policy decision for its Prolaris<sup>®</sup> prostate cancer test from one of the nation&#039;s top-five insurance companies.  This positive coverage decision follows the recently updated <a href="" rel="nofollow" target="_blank" rel="nofollow">National Comprehensive Cancer Network (NCCN) medical guidelines</a> for prostate cancer, which support Prolaris as a standard-of-care genetic test for men diagnosed with low and favorable-intermediate risk prostate cancer.<br /></p> <p>"This new positive coverage decision from a leading commercial insurer is another major milestone in expanding access to Prolaris for men with prostate cancer," said Nicole Lambert, general manager of Urology, Myriad Genetics.  "We estimate that more than 55 percent of patients eligible for Prolaris testing are now covered, and our team is working with the remaining private health insurers to ensure that their members have broad access to Prolaris."</p> <p>Since being included in NCCN guidelines, coverage has increased significantly.  In May, the company announced that Prolaris received <a href="" rel="nofollow" target="_blank" rel="nofollow">seven positive commercial coverage decisions</a>, representing roughly six million covered lives.</p> <p>Prolaris is the market-leading genetic test for prostate cancer to help guide treatment decisions for patients.  For more information about Prolaris visit: <a href="" rel="nofollow" target="_blank" rel="nofollow"></a>.</p> <p><strong>About Prolaris<sup>®</sup></strong> <br />Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease-specific mortality in patients with prostate cancer. Prolaris provides a quantitative measure of the RNA expression levels of genes involved in the progression of tumor growth.  Low gene expression is associated with a low risk of disease-specific mortality in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease-specific mortality in patients who may benefit from additional therapy. </p> <p><strong>About Myriad Genetics</strong><br />Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics.  Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose ...</p><p><a href= alt=Top-Five National Payer Issues Positive Coverage Decision for Myriad&#039;s Prolaris® Test for Prostate Cancer>Full story available on</a></p> Biotech MYGN Health Care Press Releases General MYGN US62855J1043 Biotech Health Care Press Releases General Benzinga Thu, 21 Jun 2018 11:05:00 +0000 Globe Newswire 11913139 at Caladrius Shares Extend Rally After FDA Grants Special Status To Cell Therapy <p><strong>Caladrius Biosciences Inc </strong> (NASDAQ: <a class="ticker" href="">CLBS</a>) <a href=""> shares </a>were trading sharply higher for a second straight session Wednesday after the FDA granted a&nbsp;special status for its CD34+ cell therapy.</p> <h3>What Happened</h3> <p>Caladrius Biosciences <a href=""> announced </a> Tuesday ahead of the market open that the FDA granted regenerative medicine advanced therapy, or RMAT, designation to its late-stage CD34+ cell therapy program for treating refractory angina.</p> <p>Refractory angina is chronic symptomatic coronary artery disease, with ...</p><p><a href= alt=Caladrius Shares Extend Rally After FDA Grants Special Status To Cell Therapy>Full story available on</a></p> Biotech CLBS News SHPG FDA Movers Trading Ideas SHPG CLBS News Biotech FDA Movers Trading Ideas Benzinga Wed, 20 Jun 2018 14:50:47 +0000 Shanthi Rexaline 11907747 at Diamond Equity Research Initiates Coverage on Oragenics Inc. (NYSE:OGEN) with a Valuation of $3.50 Per Share <link type="text/css" rel="stylesheet" href="" /> <p>NEW YORK, June 20, 2018 (GLOBE NEWSWIRE) -- via NetworkWire - Diamond Equity Research, a leading equity research firm with a focus on small capitalization public companies has initiated coverage of Oragenics Inc. (NYSE:<a class="ticker" href="" rel="nofollow">OGEN</a>). The in-depth 29-page initiation report includes detailed information on the Oragenics&#39;s business model, services, industry, valuation, management, and risks.<br /></p> <p>The full research report is available <a href="" rel="nofollow" target="_blank" rel="nofollow">here</a>. Highlights from the report include:</p> <p><strong>Large Market Opportunity</strong></p> <p>Oragenics has positioned AG013 to treat over 2.2 million patients worldwide annually, enough to generate over $1.5 billion in sales and secure 20-25 percent market share if approved. AG013 is a peptide oral rinse developed to treat oral mucositis (OM), one of the most common and debilitating complications that arises during cancer therapy, which still lacks approved preventive treatments. The absence of effective drugs has resulted in a large potential market for any new treatments for OM. On May 30, 2018, Oragenics&#039; announced positive results of an interim safety analysis of AG013 in its ongoing study of an initial group of 20 patients enrolled in its 200-patient phase 2 clinical trial.</p> <p>Oragenics is also developing OG716, a second-generation variant of MU1140, identified for its potential effectiveness in treating clostridium difficile infections (CDI), which affects 500,000 people a year in the U.S. alone; associated deaths have increased 400 percent in the past two decades. The CDI treatment market is growing rapidly, with U.S. sales projected at $426 million in 2019, according to ...</p><p><a href= alt=Diamond Equity Research Initiates Coverage on Oragenics Inc. (NYSE:OGEN) with a Valuation of $3.50 Per Share>Full story available on</a></p> Biotech OGEN Press Releases General OGEN Biotech Press Releases General Benzinga Wed, 20 Jun 2018 13:30:00 +0000 Globe Newswire 11907736 at NewLink Genetics Announces Updated Data for Indoximod Plus Radio-Immunotherapy in DIPG to be Presented at ISPNO 2018 Meeting <link type="text/css" rel="stylesheet" href="" /> <p align="justify">AMES, Iowa, June 20, 2018 (GLOBE NEWSWIRE) -- <a href="" rel="nofollow" target="_blank" rel="nofollow">NewLink Genetics Corporation</a> (NASDAQ:<a class="ticker" href="" rel="nofollow">NLNK</a>) today announced that updated data for patients with diffuse intrinsic pontine glioma (DIPG) from <a href="" rel="nofollow" target="_blank" rel="nofollow">NLG2105</a>, a Phase 1 study evaluating indoximod in combination with radiation and chemotherapy for the treatment of pediatric patients with progressive brain tumors, will be presented at the <a href="" rel="nofollow" target="_blank" rel="nofollow">International Symposium on Pediatric Neuro-Oncology (ISPNO)</a> in Denver, Colorado.  The presentation session and time are noted below. <br /></p> <ul type="disc"> <li>Poster Session 1: IMMU-25 – <em>Radio-immunotherapy using the IDO pathway inhibitor indoximod for children with newly-diagnosed DIPG, </em><em>to be presented by Theodore S. Johnson, M.D.,</em> <em>Ph.D., </em><a href="" rel="nofollow" target="_blank" rel="nofollow">Georgia Cancer Center,</a><em> Augusta University,</em> Sunday, July 1, 5:00PM – 6:30PM MT, Hyatt Regency Denver</li> </ul> <p align="justify"><strong>About Indoximod</strong></p> <p align="justify">Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology ...</p><p><a href= alt=NewLink Genetics Announces Updated Data for Indoximod Plus Radio-Immunotherapy in DIPG to be Presented at ISPNO 2018 Meeting>Full story available on</a></p> Biotech NLNK Health Care Press Releases General NLNK Biotech Health Care Press Releases General Benzinga Wed, 20 Jun 2018 13:00:00 +0000 Globe Newswire 11907427 at