Biotech https://www.benzinga.com/views/taxonomy/term/19868 en The Street May Be Underappreciating Alder Biopharma's Phase 3 Data https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9665536/the-street-may-be-underappreciating-alder-biopharmas-pha <p>Shares of <b>Alder Biopharmaceuticals Inc</b> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/aldr#NASDAQ">ALDR</a>) hit a new 52-week low Wednesday for the second consecutive day as many investors <A href="http://www.marketwatch.com/story/alder-biopharma-stock-drops-nearly-20-as-investors-shrug-off-positive-migraine-drug-results-2017-06-27">found fault</a> with the company&#039;s results from a phase 3 trial of its Eptinezumab therapy for the treatment of migraines.</p> <p>Piper Jaffray&#039;s <a href="https://www.tipranks.com/analysts/charles-duncan">Charles Duncan</a>, Ph.D. <A href="https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9659112/piper-jaffray-defends-alder-despite-stock-slump-looks-to">defended the company&#039;s results</a> in a research report Tuesday. On Wednesday, analysts at Credit Suisse turned incrementally bearish on the stock but still see further upside ahead.</p> <p>Credit Suisse&#039;s <a href="https://www.tipranks.com/analysts/vamil-divan">Vamil Divan</a>, MD downgrades <a href="https://www.benzinga.com/stock/aldr">Alder&#039;s stock</a> rating from Outperform to Neutral with a price target lowered from $30 to ...</p><p><a href=https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9665536/the-street-may-be-underappreciating-alder-biopharmas-pha alt=The Street May Be Underappreciating Alder Biopharma&#039;s Phase 3 Data>Full story available on Benzinga.com</a></p> Alder Biopharma ALDR Analyst Color Biotech Charles Duncan eptinezumab migraine News Vamil Divan Downgrades Price Target Analyst Ratings Movers General ALDR News Analyst Color Biotech Downgrades Price Target Analyst Ratings Movers General Benzinga Wed, 28 Jun 2017 19:51:15 +0000 Jayson Derrick 9665536 at https://www.benzinga.com With 'Tunnel's End' In Sight, Deutsche Upgrades Bio-Rad Labs https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9664521/with-tunnels-end-in-sight-deutsche-upgrades-bio-rad-labs <p>Deutsche Bank <a href="https://www.benzinga.com/analyst-ratings/upgrades/17/06/9664219/benzingas-top-upgrades-downgrades-for-june-28-2017"> upgraded </a> shares of <strong> Bio-Rad Laboratories, Inc. </strong> (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/bio#NYSE">BIO</a>), as it sees light at the end of the tunnel, given the <a href="https://www.benzinga.com/media/cnbc/17/04/9358839/corvexs-keith-meister-talks-strategy-recent-success-in-bio-rad"> company&#039;s </a> ability to accelerate sales growth and expand margins.</p> <h3><strong>Investments To Bear Fruit</strong></h3> <p>Analyst <a href="https://www.tipranks.com/analysts/dan-leonard">Dan Leonard</a> expects the company&#039;s outsized investment in organizational infrastructure for over seven years to begin to bear fruit. The company&#039;s transition of all of its manufacturing and 70 percent of its sales to SAP enterprise resource planning system would enable it to reap the benefits of structural changes in Europe and wind down costs and duplicate investments associated with the SAP implementation.</p> <p>Additionally, the analyst expects the move to help simplify IT ...</p><p><a href=https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9664521/with-tunnels-end-in-sight-deutsche-upgrades-bio-rad-labs alt=With &#039;Tunnel&#039;s End&#039; In Sight, Deutsche Upgrades Bio-Rad Labs>Full story available on Benzinga.com</a></p> Analyst Color BIO Biotech Dan Leonard Deutsche Bank Long Ideas News Upgrades Price Target Analyst Ratings Movers Trading Ideas General BIO US0905722072 Long Ideas News Analyst Color Biotech Upgrades Price Target Analyst Ratings Movers Trading Ideas General Benzinga Wed, 28 Jun 2017 16:22:19 +0000 Shanthi Rexaline 9664521 at https://www.benzinga.com Mateon Therapeutics Announces New Interim Preclinical Data on CA4P in Combination with Checkpoint Inhibitors https://www.benzinga.com/pressreleases/17/06/g9663320/mateon-therapeutics-announces-new-interim-preclinical-data-on-ca4p-in-c <link type="text/css" rel="stylesheet" href="http://www.globenewswire.com/styles/gnw_nitf.css" /> <ul> <li><strong><em><strong>CA4P in combination with anti-CTLA-4 antibodies resulted in 77% reduction in tumor size compared to anti-CTLA-4 antibodies alone and 89% reduction compared to control</strong></em></strong><br /></li> <li><strong><em><strong>Survival benefit observed for animals receiving combination therapy</strong></em></strong></li> </ul> <p>SOUTH SAN FRANCISCO, Calif., June 28, 2017 (GLOBE NEWSWIRE) -- Mateon Therapeutics, Inc. (OTCQX:<a class="ticker" href="https://www.benzinga.com/stock/MATN#OTCQX" rel="nofollow">MATN</a>), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, today announced that CA4P in combination with a checkpoint inhibitor significantly reduced tumor size in a CT-26 colon cancer animal model.</p> <table border="0"> <tr> <td> <table width="305" 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="https://www.globenewswire.com/NewsRoom/AttachmentNg/e515d093-4f60-4757-aa91-49c20abf4f55" rel="nofollow"><img src="https://resource.globenewswire.com/Resource/Download/e515d093-4f60-4757-aa91-49c20abf4f55?size=2" border="0" width="300" height="186" alt="Mean Tumor Volume in CT-26 Colorectal Mouse Model" /></a></td> </tr> <tr> <td class="gnw_media_caption" width="5"></td> <td align="left" class="gnw_media_caption">Mean Tumor Volume in CT-26 Colorectal Mouse Model</td> </tr> </table> </td> </tr> </table> <p> <br /><br /> </p></td> </tr> </table> <p>Mateon evaluated its lead investigational drug CA4P, which is also currently being studied in a phase 2/3 clinical trial in platinum-resistant ovarian cancer, in a syngeneic mouse model in combination with a checkpoint inhibitor. In order to assess the effects of CA4P on more advanced and difficult-to-treat tumors, tumors in this study were allowed to grow for 13 days prior to treatment. Consequently, beginning tumor sizes were approximately three times larger than those generally evaluated in preclinical studies. Results following two weeks of treatment are as follows:</p> <table class="gnw_table_border_collapse gnw_table_border_collapse gnw_table_border_collapse gnw_table_border_collapse gnw_table_border_collapse gnw_table_border_collapse hugin"> <tr> <td class="gnw_border_top_solid gnw_border_right_solid gnw_border_bottom_solid gnw_border_left_solid gnw_vertical_align_bottom hugin"><strong> </strong><br /><br /> <strong>  Treatment</strong></td> <td class="gnw_border_top_solid gnw_border_right_solid gnw_border_bottom_solid gnw_align_center gnw_vertical_align_bottom hugin"><strong>Baseline</strong><br /><strong>Tumor Size</strong></td> <td class="gnw_border_top_solid gnw_border_right_solid gnw_border_bottom_solid gnw_align_center gnw_vertical_align_bottom hugin"><strong>Day 14</strong><br /><strong>Tumor Size</strong></td> <td class="gnw_border_top_solid gnw_border_right_solid gnw_border_bottom_solid gnw_align_center gnw_vertical_align_bottom hugin"><strong>Day 14 Survival</strong></td> <td class="gnw_border_top_solid gnw_border_right_solid gnw_border_bottom_solid gnw_align_center gnw_vertical_align_bottom hugin"><strong>Survival</strong><br /><strong>p-values</strong></td> </tr> <tr> <td class="gnw_border_right_solid gnw_border_bottom_solid ...</tr></table><p><a href=https://www.benzinga.com/pressreleases/17/06/g9663320/mateon-therapeutics-announces-new-interim-preclinical-data-on-ca4p-in-c alt=Mateon Therapeutics Announces New Interim Preclinical Data on CA4P in Combination with Checkpoint Inhibitors>Full story available on Benzinga.com</a></p> Biotech MATN Press Releases General MATN Biotech Press Releases General Benzinga Wed, 28 Jun 2017 11:30:00 +0000 Globe Newswire 9663320 at https://www.benzinga.com Histogenics Completes Enrollment for Phase 3 Clinical Trial of Neocart® to Treat Knee Cartilage Damage https://www.benzinga.com/pressreleases/17/06/g9660880/histogenics-completes-enrollment-for-phase-3-clinical-trial-of-neocart- <link type="text/css" rel="stylesheet" href="http://www.globenewswire.com/styles/gnw_nitf.css" /> <p align="center"><strong><em>– On Track for Top-Line One Year Superiority Data and Potential BLA </em></strong><strong><em>Filing in Third Quarter of 2018 –</em></strong></p> <table border="0"> <tr> <td> <table width="279" 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="https://www.globenewswire.com/NewsRoom/AttachmentNg/b88fc785-a19b-44d3-8b9d-ea325922c6ed" rel="nofollow"><img src="https://resource.globenewswire.com/Resource/Download/b88fc785-a19b-44d3-8b9d-ea325922c6ed?size=2" border="0" width="274" height="300" alt="Knee Cartilage Damage" /></a></td> </tr> <tr> <td class="gnw_media_caption" width="5"></td> <td align="left" class="gnw_media_caption">Articular cartilage can be damaged by injury or normal wear and tear (<a href="http://www.neocartimplant.com/cartilage-injury" title="http://www.neocartimplant.com/cartilage-injury" rel="nofollow">http://www.neocartimplant.com/cartilage-injury</a>).</td> </tr> </table> </td> </tr> </table> <p> <br /><br /> </p></td> </tr> </table> <p align="center"><strong><em>– Novel Tissue Implant Potentially Accelerates Recovery and Reduces Pain through Proprietary Process that Replicates the Body&#039;s Ability to Grow Cartilage as a Juvenile –</em></strong></p> <p align="justify">WALTHAM, Mass., June 27, 2017 (GLOBE NEWSWIRE) -- Histogenics Corporation (Histogenics) (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HSGX#NASDAQ" rel="nofollow">HSGX</a>), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced the completion of patient enrollment of its NeoCart<sup>®</sup> Phase 3 clinical trial in accordance with the Special Protocol Assessment (SPA) agreement with the United States Food and Drug Administration (FDA).  Histogenics expects to report top-line 1-year superiority data in the third quarter of 2018, followed by a potential Biologics License Application (BLA) filing.</p> <p align="justify">"We are proud to have completed enrollment in the largest prospectively designed, randomized clinical trial evaluating the safety and efficacy of a cellular therapy to treat knee cartilage defects," said Gloria Matthews, Chief Medical Officer of Histogenics.  "There is a substantial need for novel treatment options for knee cartilage damage, such as NeoCart, that have the potential to provide effective pain relief and restore function.  We would like to thank our committed employees, investigators, coordinators and patients for helping us reach this important milestone and look forward to potentially bringing this therapy to patients as quickly as possible."</p> <p>A photo accompanying this announcement is available at <a href="https://www.globenewswire.com/Tracker?data=r5PAqMJsxSzDk-diTgJHUbzJnHRUJKffZ5a6IJeNaHSI_uRtxFjTqEkWaEUkfuYhkEIhrGbn9NhUP2jfQy2dZkGbHEPB7BG0kzod0fxVElO3MEEXbIxk_HwOsIU_iHyrwRax4r2WsZFdt1I8ag72BtZKW4zEO0oWpCNDsQSzfhErf0T5tT4B64HnBJcWwIW5y1lOMdrP5U9Rn3lKIwxiuCOTlPtd6vo30P-OwgTDTGqaJFMsSSfpM4IKcHakqGq4E3ybIFyTuDl24097c71Kxg==" rel="nofollow" target="_blank" rel="nofollow">http://www.globenewswire.com/NewsRoom/AttachmentNg/b88fc785-a19b-44d3-8b9d-ea325922c6ed</a>.</p> <p align="justify">The randomized Phase 3 clinical trial is designed to evaluate the safety and efficacy in 245 patients, of NeoCart compared to microfracture, the current standard of care for the treatment of articular cartilage defects.  The primary endpoint of the trial is a dual-threshold responder analysis measuring the improvement in the pain and function of each patient treated with NeoCart compared to those treated with microfracture one year after treatment.  The Phase 3 clinical trial design and primary endpoint is based on Histogenics&#039; 30-patient Phase 2 clinical trial that demonstrated highly statistically significant superiority results of NeoCart compared to microfracture at one year. </p> <p align="justify">A video accompanying this release is available at <a href="https://www.globenewswire.com/Tracker?data=r5PAqMJsxSzDk-diTgJHUbzJnHRUJKffZ5a6IJeNaHSI_uRtxFjTqEkWaEUkfuYhId5paEYAVE6rChW_08wIPxyw5-3ho5ilq_q9E4I9tszkhrZwKLg-XxaJ3c7o2peqMcIVb3oJfU_aQRC93CqOuDl1Yr-K2jvYp-RpqJdSWVZDCmE1sgVxcbyZH8OGrDT8Ggloga1cLigqg2_AmThnWq1u7H8i_3nZoZWYI_cyIt9nubr30x6O4s_is799iY6Cjz6wXQ5qQxG9f24GAbVfxw==" rel="nofollow" target="_blank" rel="nofollow">http://www.globenewswire.com/NewsRoom/AttachmentNg/3fb223fe-934d-42f1-a978-6759ece223cd</a></p> <p align="justify">"Our recent market research confirmed that this market is largely underserved due to the lack of rapid, yet durable therapies that treat the underlying problem with one-third of surgeons unsatisfied with the current treatment options.  As a result, two-thirds or more of the patients who suffer from knee cartilage injuries remain untreated, due to the variable outcomes and lengthy rehabilitation associated with existing treatments, often leading to debilitating osteoarthritis.  Specifically, patients with defects that are smaller than four centimeters in size, which we believe represent the large majority of the market, are less likely to receive surgical treatment in part due to the low satisfaction with and poor outcomes of existing treatments.  Against this background, we believe NeoCart could expand the market by meeting ...</p><p><a href=https://www.benzinga.com/pressreleases/17/06/g9660880/histogenics-completes-enrollment-for-phase-3-clinical-trial-of-neocart- alt=Histogenics Completes Enrollment for Phase 3 Clinical Trial of Neocart® to Treat Knee Cartilage Damage>Full story available on Benzinga.com</a></p> Biotech HSGX Health Care Press Releases General HSGX Biotech Health Care Press Releases General Benzinga Tue, 27 Jun 2017 20:01:00 +0000 Globe Newswire 9660880 at https://www.benzinga.com Analysts Remain Encouraged By Bellicum Pharma's Progress https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9660249/analysts-remain-encouraged-by-bellicum-pharmas-progress <p><strong>Bellicum Pharmaceuticals Inc</strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/blcm#NASDAQ">BLCM</a>) has managed to keep <a href="https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9652731/bellicum-pharmaceuticals-eha-presentation-helps-validate">sell-side analysts</a> encouraged with its last Friday&#039;s presentation at the <a href="https://www.ehaweb.org/"> European Hematology Association </a> meeting. The latest sell-side firm to express its happiness over the data was Raymond James.</p> <p>Analyst <a href="https://www.tipranks.com/analysts/reni-benjamin">Reni Benjamin</a> termed the update on the company&#039;s ongoing phase 1/2 study of BPX-501 at the EHA as incrementally positive. The analyst said he continues to be encouraged that the treatment benefits were largely maintained, as more patients were treated ...</p><p><a href=https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9660249/analysts-remain-encouraged-by-bellicum-pharmas-progress alt=Analysts Remain Encouraged By Bellicum Pharma&#039;s Progress>Full story available on Benzinga.com</a></p> Analyst Color Biotech BLCM EHA European Hematology Association Long Ideas Raymond James Reni Benjamin Reiteration Analyst Ratings Trading Ideas General BLCM Long Ideas Analyst Color Biotech Reiteration Analyst Ratings Trading Ideas General Benzinga Tue, 27 Jun 2017 19:07:28 +0000 Shanthi Rexaline 9660249 at https://www.benzinga.com Pharmaceuticals Abound Among This Week's 11 IPOs https://www.benzinga.com/general/biotech/17/06/9659780/pharmaceuticals-abound-among-this-weeks-11-ipos <p>The public markets appear to be in recovery mode from 2016&rsquo;s<a href="https://www.benzinga.com/general/education/17/04/9330639/committee-urges-change-in-class-action-regulations-as-ipo-market-dri"> light class</a> of initial public offerings. With 11 companies listing this week, marking a <a href="https://www.ft.com/content/7e42949a-5a9f-11e7-b553-e2df1b0c3220">two-year record</a>, this year&rsquo;s 81-member cohort is on pace to eclipse 2016&rsquo;s batch of 119, the smallest group since 2009.</p> <p>Here is a preview of the offerings set between June 27 and June 30.</p> <h3><strong>11 IPOs This Week</strong></h3> <li><strong><a href="http://www.avenuetx.com/">Avenue Therapeutics, Inc.</a></strong> (ATXI) will issue 5 million shares between $5 and $7 Tuesday on the Nasdaq. A <strong>Fortress Biotech Inc</strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/fbio#NASDAQ">FBIO</a>) subsidiary, the pharmaceutical acquires, develops and commercializes products for in-hospital use, such as its post-operative palliative.</li> <li><strong><a href="https://www.esquirebank.com/">Esquire Financial Holdings, Inc. </a></strong>(ESQ) will issue more than 2.36 shares between $14 and $16 Tuesday on the Nasdaq. The business-focused commercial bank has two locations in New York and Florida.</li> <li><strong><a href="http://www.mersana.com/">Mersana Therapeutics, Inc.</a></strong> (MRSN) will issue 5 million shares ...</li><p><a href=https://www.benzinga.com/general/biotech/17/06/9659780/pharmaceuticals-abound-among-this-weeks-11-ipos alt=Pharmaceuticals Abound Among This Week&#039;s 11 IPOs>Full story available on Benzinga.com</a></p> Aileron Therapeutics AKCA Akcea Therapeutics ALRN APRN ATXI Avenue Therapeutics Biotech Blue Apron Holdings BY Byline Bancorp CMCSA CVX DOVA Dova Pharmaceuticals ESQ Esquire Financial Holdings FBIO IONS IPOs Mersana Therapeutics MRSN News PIXY ShiftPixy SNE Tintri TNTR TM TPG Pace Holdigns TPGHU Futures IPOs Markets Trading Ideas General CMCSA US20030N1019 CVX US1667641005 SNE US8356993076 TM US8923313071 FBIO IONS News Biotech Futures IPOs Markets Trading Ideas General Benzinga Tue, 27 Jun 2017 18:34:32 +0000 Elizabeth Balboa 9659780 at https://www.benzinga.com Gates Foundation Deal Opens Things Up For OraSure https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9659403/gates-foundation-deal-opens-things-up-for-orasure <p>Canaccord Genuity said in note Tuesday the Gates Foundation <a href="http://www.genengnews.com/gen-news-highlights/orasure-wins-up-to-20m-from-gates-foundation-toward-hiv-self-test/81254575"> agreement </a> helps open up the spigot for <strong>OraSure Technologies, Inc.</strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/osur#NASDAQ">OSUR</a>). The firm lifted its price target in the wake of the news.</p> <p>Canaccord noted that the deal is similar to <strong> Danaher Corporation </strong> (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/dhr#NYSE">DHR</a>) unit Cepheid&#039;s TB test via its HBDC program.</p> <h3><strong>Multimillion-Dollar Revenue Opportunity</strong></h3> <p>Elaborating on the deal terms, analyst <a href="https://www.tipranks.com/analysts/mark-massaro">Mark Massaro</a> said <a href="https://www.benzinga.com/analyst-ratings/analyst-color/16/09/8471412/btig-downgrades-orasure-technologies-to-neutral-citing-v">OraSure</a> has agreed with the <a href="https://www.benzinga.com/general/education/17/06/9577744/5-books-bill-gates-wants-you-to-read-this-summer">Gates Foundation</a> to deploy its new <a href="http://www.oraquick.com/">OraQuick HIV self-test</a> to about 50 developing countries across Africa and Asia. The agreement would fetch the company funding of about $20 million over four years. </p> <p><a href="https://www.tipranks.com/analysts/mark-massaro"><img src="https://cdn2.benzinga.com/files/images/2017/June/27/tipranks.png" width="350" height="35" alt="tipranks.png" /></a></p> <p>The analyst thinks the news would add upside of about $3 million to $6 million of revenue per year to his model, beginning in 2018, with some partial lift in 2017. </p> <p>Canaccord expects OraSure to capture revenues per test in the range of $4-$5 on average. Although the rate ...</p><p><a href=https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9659403/gates-foundation-deal-opens-things-up-for-orasure alt=Gates Foundation Deal Opens Things Up For OraSure>Full story available on Benzinga.com</a></p> Analyst Color Biotech Canaccord Genuity DHR HIV Long Ideas OSUR WHO World Health Organization Education Health Care Price Target Reiteration Top Stories Analyst Ratings Movers Trading Ideas General OSUR US68554V1089 DHR US2358511028 Long Ideas Analyst Color Biotech Education Health Care Price Target Reiteration Top Stories Analyst Ratings Movers Trading Ideas General Benzinga Tue, 27 Jun 2017 18:07:11 +0000 Shanthi Rexaline 9659403 at https://www.benzinga.com The Prospect Of The U.S. Blocking The Bayer-Monsanto Deal Can't Be Dismissed https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9658712/the-prospect-of-the-u-s-blocking-the-bayer-monsanto-deal <p>Susquehanna analyst <a href="https://www.tipranks.com/analysts/don-carson">Don Carson</a> downgraded <strong>Monsanto Company</strong> (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/mon#NYSE">MON</a>) from Positive to Neutral, while raising its price target from $125 to $128.</p> <p>The downgrade is not a result of increasing headwinds or poor performance, but rather because the 9-percent upside from <strong>Bayer AG (ADR)</strong> (OTC: <a class="ticker" href="https://www.benzinga.com/stock/bayry#OTC">BAYRY</a>)&#039;s <a href="https://www.benzinga.com/news/16/09/8456367/bayer-to-buy-monsanto-finally-for-66-billion">$128 per share acquisition</a> is below Susquehanna&rsquo;s 15-percent minimum for a Positive rating.</p> <h3><strong>Why Downgrade If Acquisition Is All But Certain?</strong></h3> <p>Carson is confident that the Bayer acquisition will close, albeit with some revisions at the suggestion of antitrust authorities in the U.S. and South Africa, but notes that the risk of a block cannot be dismissed.</p> <p>Carson&rsquo;s concerns stem from political considerations more so than economic ones.</p> <p>The consensus expectation that ...</p><p><a href=https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9658712/the-prospect-of-the-u-s-blocking-the-bayer-monsanto-deal alt=The Prospect Of The U.S. Blocking The Bayer-Monsanto Deal Can&#039;t Be Dismissed>Full story available on Benzinga.com</a></p> Analyst Color Bayer BAYRY Biotech ChemChina DD Don Carson DOW Earnings MON News Susquehanna SYT Guidance Downgrades Futures Price Target Previews Politics Markets Analyst Ratings Trading Ideas General DD US2635341090 DOW US2605431038 MON US61166W1018 SYT US87160A1007 BAYRY US0727303028 News Analyst Color Earnings Biotech Guidance Downgrades Price Target Futures Previews Politics Markets Analyst Ratings Trading Ideas General Benzinga Tue, 27 Jun 2017 16:24:39 +0000 Ezra Schwarzbaum 9658712 at https://www.benzinga.com Piper Jaffray Defends Alder Despite Stock Slump, Looks To What's Next In Migraine Management https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9659112/piper-jaffray-defends-alder-despite-stock-slump-looks-to <p>Shares of <b>Alder Biopharmaceuticals Inc</b> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/aldr#NASDAQ">ALDR</a>) <A href="https://www.benzinga.com/trading-ideas/technicals/17/06/9658778/alder-biopharma-plummets-after-results-of-eptinezumab-1-phase">lost more than 20 percent</a> on Tuesday and hit a new 52-week low of $13.80 despite <A href="http://www.marketwatch.com/story/alder-biopharma-stock-drops-nearly-20-as-investors-shrug-off-positive-migraine-drug-results-2017-06-27">reporting positive results</a> for its late-stage migraine prevention drug called eptinezumab.</p> <p>Eptinezumab was successful in meeting the primary and key secondary endpoints in a phase 3 trial, and the company plans on filing for approval of the drug with the U.S. Food and Drug Administration in the bottom half of 2017.</p> <p>Alder&#039;s results "have been interpreted in a tough competitive context," Piper Jaffray&#039;s <a href="https://www.tipranks.com/analysts/charles-duncan">Charles C. Duncan</a>, Ph.D., commented in a research report. Investors should be focusing on the "good-sized" (40 percent-plus) subgroup of "super-type responders to therapy after just two doses, and some of whom convert as early as the first several days on therapy."</p> <p>"While the placebo-adjusted reduction in monthly <a href="https://www.benzinga.com/analyst-ratings/analyst-color/16/09/8514285/alder-biopharma-could-lead-the-migraine-market-brean-ass">migraine days</a> over weeks 1-12 looked &#039;just ok&#039; we also note that, potentially consistent with an IV therapy, the placebo response was higher than for other Phase III programs we&#039;ve seen," ...</p><p><a href=https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9659112/piper-jaffray-defends-alder-despite-stock-slump-looks-to alt=Piper Jaffray Defends Alder Despite Stock Slump, Looks To What&#039;s Next In Migraine Management>Full story available on Benzinga.com</a></p> Alder Biopharmaceuticals ALDR Analyst Color Biotech Charles Duncan eptinezumab Long Ideas migraine News Piper Jaffray Health Care Reiteration FDA Analyst Ratings Movers Trading Ideas General ALDR Long Ideas News Analyst Color Biotech Health Care Reiteration FDA Analyst Ratings Movers Trading Ideas General Benzinga Tue, 27 Jun 2017 16:11:08 +0000 Jayson Derrick 9659112 at https://www.benzinga.com Here's The Beef With Bluebird's Starbeam Study Results https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9658082/heres-the-beef-with-bluebirds-starbeam-study-results <p><b>Bluebird bio Inc</b> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/blue#NASDAQ">BLUE</a>), a clinical-stage biotechnology company that focuses on developing gene therapies for severe diseases and cancer, <A href="http://investor.bluebirdbio.com/phoenix.zhtml?c=251820&amp;p=irol-newsArticle&amp;ID=2283186">reported on Monday</a> top-line results from a study called Starbeam.</p> <p>Starbeam explores the company&#039;s LentiD investigational gene therapy for the treatment of boys under the age of 18 with cerebral adrenoleukodystrophy. Top-line data from the ongoing Phase 2/3 study showed that as of June 13, 88 percent of patients with CALD who completed two years of follow-up post-Lenti-D treatment remain free of major functional disabilities, the company said in a press release. This marks the primary endpoint of the trial and exceeded the predefined interim efficacy benchmark for the study of MFD-free survival of 76 percent.</p> <h3><strong>BTIG: ...</strong></h3><p><a href=https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9658082/heres-the-beef-with-bluebirds-starbeam-study-results alt=Here&#039;s The Beef With Bluebird&#039;s Starbeam Study Results>Full story available on Benzinga.com</a></p> Analyst Color Biotech BLUE btig cancer Cancer Stocks Dane Leone LentiD Long Ideas News STARBEAM Health Care Reiteration Analyst Ratings Movers Trading Ideas General BLUE Long Ideas News Analyst Color Biotech Health Care Reiteration Analyst Ratings Movers Trading Ideas General Benzinga Tue, 27 Jun 2017 14:48:37 +0000 Jayson Derrick 9658082 at https://www.benzinga.com Here's What The Latest Thermo Fisher Approval Really Means And Why It's So Important https://www.benzinga.com/general/biotech/17/06/9654996/heres-what-the-latest-thermo-fisher-approval-really-means-and-why-its- <p>Thermo Fisher Scientific Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/tmo#NYSE">TMO</a>) just announced that the Food and Drug Administration (FDA) has approved its Oncomine Dx Target Test, a next-generation sequencing test that simultaneously screens tumor samples for biomarkers associated with various available lung cancer therapies.</p> <p>The company is trading down on the announcement, suggesting there exists some uncertainty as to the implications of this approval for Thermo Fisher and its shareholders going forward. This uncertainty seems rooted in the complexity of the technology involved, and that testing equipment is not as enticing from an investor perspective as a drug approval proper. Laboratory-based testing, whether it be oncology or otherwise, is a complex field, and interpreting developments in the space can be difficult.</p> <p>With this in mind, here is a look at the approval, the technology involved, and what it means for both Thermo Fisher and for the wider healthcare space as a whole.</p> <p>The Oncomine Dx Target Test itself is not the primary technology here; instead, it is designed to work as an add-on to what&#39;s called the Ion PGM Dx System, another Thermo Fisher technology that picked up <a href="https://www.google.es/url?sa=t&amp;rct=j&amp;q=&amp;esrc=s&amp;source=web&amp;cd=1&amp;cad=rja&amp;uact=8&amp;ved=0ahUKEwjd-f21ldTUAhXPyRoKHfsQAI8QFggoMAA&amp;url=http%3A%2F%2Fnews.thermofisher.com%2Fpress-release%2Flife-technologies%2Fthermo-fisher-scientific-announces-listing-ion-">approval</a> as a Class II medical device back at the end of 2014.</p> <p>To understand why the system is important, it is important to understand its precursor.</p> <p>Before the Ion PGM Dx System, the profiling of a genome sample required a large amount of base material, primarily because the methods used were only able to draw a very small and limited amount of usable material from the genome under analysis.</p> <p>Through a process called PCR amplification, the PGM Dx System is able to take an incredibly small amount of starter material and draw a usable test sample from it. There&#39;s no need to go into too much detail here, but by way of a brief introduction, the technology uses a silicon chip that somewhat resembles the silicon chip that stores data in a camera. Instead of storing image-based information on pixels, however, the chip stores genetic information in little wells spread evenly across the chip. The genetic information is derived from applying the PCR amplification process to a tiny sample of genetic material. Once this genetic information is stored, the wells are filled with various primers and if the primer matches the genetic base stored in the ...</p><p><a href=https://www.benzinga.com/general/biotech/17/06/9654996/heres-what-the-latest-thermo-fisher-approval-really-means-and-why-its- alt=Here&#039;s What The Latest Thermo Fisher Approval Really Means And Why It&#039;s So Important>Full story available on Benzinga.com</a></p> Biotech Long Ideas News OPGN TMO FDA Trading Ideas General TMO US8835561023 OPGN Long Ideas News Biotech FDA Trading Ideas General Benzinga Mon, 26 Jun 2017 20:20:02 +0000 Mark Collins 9654996 at https://www.benzinga.com A Surprisingly Clean, Straightforward Approval Gives Portola Pharma Shares A Shot Of Upside https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9653648/a-surprisingly-clean-straightforward-approval-gives-port <p><strong> Portola Pharmaceuticals Inc </strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ptla#NASDAQ">PTLA</a>) <a href="http://investors.portola.com/phoenix.zhtml?c=198136&amp;p=irol-newsArticle&amp;ID=2282890"> announced </a> last Friday the FDA has approved Brvyxxa, its anti-coagulant candidate. <a href=https://www.benzinga.com/general/biotech/17/06/9648076/portola-receives-fda-approval-for-bevyxxa> Bevyxxa </a> is an oral, once-daily Factor Xa inhibitor, was granted a Fast Track designation and approved under Priority review, which reduces the timeframe for review to six months, as opposed to the ten months for a Standard review.</p> <p>The company said it expects to launch Bevyxxa between August and November 2017.</p> <h3><strong>Reaching The Apex</strong></h3> <p>Commenting on the approval, Credit Suisse said Portola had reached its apex with Bevyxxa&#039;s surprisingly clean and straightforward approval, as opposed to its expectations that the mixed data from APEX study and an unfavorable risk/reward reduced ...</p><p><a href=https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9653648/a-surprisingly-clean-straightforward-approval-gives-port alt=A Surprisingly Clean, Straightforward Approval Gives Portola Pharma Shares A Shot Of Upside>Full story available on Benzinga.com</a></p> Analyst Color Biotech BMY Brvyxxa Credit Suisse MRK News PFE PTLA Vamil Divan Price Target Reiteration FDA Analyst Ratings Movers General BMY US1101221083 MRK US58933Y1055 PFE US7170811035 PTLA News Analyst Color Biotech Price Target Reiteration FDA Analyst Ratings Movers General Benzinga Mon, 26 Jun 2017 18:03:58 +0000 Shanthi Rexaline 9653648 at https://www.benzinga.com Is It Time To Step To The Sidelines On Regeneron? https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9653115/is-it-time-to-step-to-the-sidelines-on-regeneron <p><strong> Regeneron Pharmaceuticals Inc </strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/regn#NASDAQ">REGN</a>) shares have been on an uptrend since late April, adding roughly 40 percent. The run up has led to worries over whether the stock has gotten ahead of fundamentals.</p> <p>Bernstein <a href="https://www.benzinga.com/analyst-ratings/upgrades/17/06/9652224/benzingas-top-upgrades-downgrades-for-june-26-2017">downgraded</a> <a href="https://www.benzinga.com/general/biotech/17/05/9500302/regeneron-and-sanofi-have-a-near-term-fda-catalyst">Regeneron,</a> citing a more balanced risk-reward scenario. The firm attributed the run up to the successful launch of <a href="http://marketrealist.com/2017/06/dupixent-may-prove-major-growth-driver-regeneron-2017/"> Dupixent </a> coupled with sector re-rating as concerns about government action receded.</p> <p>Analyst <a href="https://www.tipranks.com/analysts/aaron-gal">Aaron Gal </a>said the stock is less likely to outperform the broader drug sector.</p> <ul> <li>The positive view on Dupixent launch is now fully discounted in the stock price. Additionally, the launch does not guarantee achievement of peak sales.</li> <li>To achieve a 15-percent ...</li></ul><p><a href=https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9653115/is-it-time-to-step-to-the-sidelines-on-regeneron alt=Is It Time To Step To The Sidelines On Regeneron?>Full story available on Benzinga.com</a></p> Analyst Color Bernstein Biotech Dupixent REGN Downgrades Price Target Analyst Ratings General REGN US75886F1075 Analyst Color Biotech Downgrades Price Target Analyst Ratings General Benzinga Mon, 26 Jun 2017 17:27:53 +0000 Shanthi Rexaline 9653115 at https://www.benzinga.com Bellicum Pharmaceuticals EHA Presentation Helps Validate Its Platform https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9652731/bellicum-pharmaceuticals-eha-presentation-helps-validate <p>After attending the <a href="https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9648454/despite-a-volatile-trading-week-bellicums-eha-presentati"> European Hematology Association </a>meeting, Wells Fargo said it views updated results <strong> Bellicum Pharmaceuticals Inc </strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/blcm#NASDAQ">BLCM</a>) presented for BPX-501, validated its controllable cell therapy platform. This, according to the firm, is supportive of a potential new standard of care in haploidentical stem cell transplant.</p> <p>Analyst <a href="https://www.tipranks.com/analysts/jim-birchenough">Jim Birchenough</a> noted that <a href="https://www.benzinga.com/general/biotech/17/06/9626344/whats-gotten-into-bellicum-pharmaceuticals"> Bellicum&#039;s </a> presentation at the EHA last Friday was focused on 47 pediatric leukemia patients treated at the Ospedale Pediatrico in Italy.</p> <p>BPX-501 is an allogenic T cell add-back product used after a T-cell depleted haploidentical allogenic hematopoietic stem cell transplant for both benign and malignant hematologic diseases. </p> <p>The analysts said the data pertained to 28 subjects with acute lymphocytic leukemia and 19 with acute myeloid leukemia, all of whom were in either a first or second complete response ...</p><p><a href=https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9652731/bellicum-pharmaceuticals-eha-presentation-helps-validate alt=Bellicum Pharmaceuticals EHA Presentation Helps Validate Its Platform>Full story available on Benzinga.com</a></p> Analyst Color Biotech BLCM Long Ideas News Wells Fargo Health Care Price Target Reiteration Events Analyst Ratings Trading Ideas General BLCM Long Ideas News Analyst Color Biotech Health Care Price Target Reiteration Events Analyst Ratings Trading Ideas General Benzinga Mon, 26 Jun 2017 15:11:54 +0000 Shanthi Rexaline 9652731 at https://www.benzinga.com Portola Pharmaceuticals: Expect Additional Upside From Here https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9652418/portola-pharmaceuticals-expect-additional-upside-from-he <p>Even after <strong>Portola Pharmaceuticals Inc</strong> (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ptla#NASDAQ">PTLA</a>) shares soared nearly 50 percent following news of betrixaban receiving <a href="https://www.benzinga.com/general/biotech/17/06/9648076/portola-receives-fda-approval-for-bevyxxa">FDA approval</a> (reported on <a href="https://pro.benzinga.com/?utm_source=benzinga&amp;utm_campaign=merrick">Benzinga Pro</a>), Oppenheimer analyst Jay Olson sees further upside. Olson maintains an Outperform rating on Portola with a $66 price target.</p> <h3><strong>A Closer Look At Olson&rsquo;s Bullish Theses</strong></h3> <ul> <li> Initially, management had hinted at pricing betrixaban in line with competitors, but now management has noted a pricing premium could be in play. Olson sees management ...</li></ul><p><a href=https://www.benzinga.com/analyst-ratings/analyst-color/17/06/9652418/portola-pharmaceuticals-expect-additional-upside-from-he alt=Portola Pharmaceuticals: Expect Additional Upside From Here>Full story available on Benzinga.com</a></p> Analyst Color betrixaban Biotech Jay Olson Long Ideas News Oppenheimer PTLA Price Target Reiteration Analyst Ratings Movers Trading Ideas General PTLA Long Ideas News Analyst Color Biotech Price Target Reiteration Analyst Ratings Movers Trading Ideas General Benzinga Mon, 26 Jun 2017 14:56:02 +0000 Merrick Weingarten 9652418 at https://www.benzinga.com