{"id":11483,"date":"2020-12-22T16:55:10","date_gmt":"2020-12-22T11:25:10","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=11483"},"modified":"2021-07-24T12:58:12","modified_gmt":"2021-07-24T07:28:12","slug":"pharma-happenings-fo-agios-uniqures-ultragenyx-mereo-atyr-pharma","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-fo-agios-uniqures-ultragenyx-mereo-atyr-pharma","title":{"rendered":"Agios&#8217; cancer pipeline auction; uniQure\u2019s gene therapy on hold; Ultragenyx, Mereo Deal;  aTyr Pharma Trial"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-69f7aa04a9547\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-69f7aa04a9547\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-fo-agios-uniqures-ultragenyx-mereo-atyr-pharma\/#Servier_Acquires_Agios_Cancer_Portfolio_in_a_USD_2_Billion_Deal\" >Servier Acquires Agios&#8217; Cancer Portfolio in a USD 2 Billion Deal<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-fo-agios-uniqures-ultragenyx-mereo-atyr-pharma\/#FDA_Puts_uniQures_Hemophilia_B_Gene_Therapy_on_Leash\" >FDA Puts uniQure\u2019s Hemophilia B Gene Therapy on Leash<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-fo-agios-uniqures-ultragenyx-mereo-atyr-pharma\/#Ultragenyx_Pharmaceutical_Teams_up_with_Mereo_BioPharma_for_a_Bone_Disease_Candidate\" >Ultragenyx Pharmaceutical Teams up with Mereo BioPharma for a Bone Disease Candidate<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-fo-agios-uniqures-ultragenyx-mereo-atyr-pharma\/#aTyr_Pharma_Completes_Enrollment_in_Phase_1b2a_Pulmonary_Sarcoidosis_Clinical_Trial_Testing_ATYR1923\" >aTyr Pharma Completes Enrollment in Phase 1b\/2a Pulmonary Sarcoidosis Clinical Trial Testing ATYR1923&nbsp;<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Servier_Acquires_Agios_Cancer_Portfolio_in_a_USD_2_Billion_Deal\"><\/span><strong>Servier Acquires Agios&#8217; Cancer Portfolio in a USD 2 Billion Deal<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The year is a prime witness of pricey deals and acquisitions in the pharmaceutical industry. To leave its mark, another player decided to hop onto the list. French drugmaker Servier has announced the acquisition of the Oncology business of Agios Pharmaceutical in a deal worth USD 2 billion.&nbsp;<\/p>\n\n\n\n<p>Parceled in the deal, besides Agios&#8217; co-commercialization responsibilities for Bristol Myers Squibb&#8217;s Idhifa (enasidenib), Servier announced, are Agios\u2019 oral leukemia treatment <strong>Tibsovo<\/strong>, vorasidenib, AG-270, and AG-636. <strong>Tibsovo <\/strong>approved for <a href=\"https:\/\/www.delveinsight.com\/report-store\/relapsed-refractory-acute-myeloid-leukemia-r-r-aml-epidemiology-forecast\" target=\"_blank\" rel=\"noreferrer noopener\">relapsed or refractory acute myeloid leukemia<\/a> (R\/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, is presently under investigation in two Phase III combination trials in newly diagnosed AML, and as a potential treatment for previously treated IDH1-mutant cholangiocarcinoma and IDH1-mutant myelodysplastic syndrome (MDS). <strong>Vorasidenib<\/strong> is an investigational, brain-penetrant, dual inhibitor of mutant IDH1 and IDH2 in a Phase III trial in patients with IDH-mutant low-grade glioma, <strong>AG-270<\/strong> is an investigational first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor while <strong>AG-636<\/strong> is a novel inhibitor of dihydroorotate dehydrogenase.<\/p>\n\n\n\n<p>The acquisition will help Servier bolster its presence in the oncology market. As per the company, the decision further pushes a step ahead towards its aims to become a \u201crecognized and innovative player\u201d in oncology for which Servier has allocated 50% of its overall R&amp;D budget. After the news broke, shares of Agios soared in premarket trading.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"FDA_Puts_uniQures_Hemophilia_B_Gene_Therapy_on_Leash\"><\/span><strong>FDA Puts uniQure\u2019s Hemophilia B Gene Therapy on Leash<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The fate of drugs, even if the drug appears invincible, remains unpredictable unless it passes from the eyes of almighty the USFDA. In a recent, uniQure faced backlash after its<a href=\"https:\/\/www.delveinsight.com\/report-store\/hemophilia-b-market\" target=\"_blank\" rel=\"noreferrer noopener\"> hemophilia B<\/a> gene therapy got hit with clinical hold by the USFDA.\u00a0<\/p>\n\n\n\n<p>Recently, the company announced at ASH (American Society of Hematology\u2019s annual meeting) that its Phase III HOPE-B study has been put on hold owing to the submission of a safety report in mid-December that unveiled the case of an enrolled patient (dosed over a year ago) developing <a href=\"https:\/\/www.delveinsight.com\/report-store\/hepatocellular-carcinoma-market\" target=\"_blank\" rel=\"noreferrer noopener\">hepatocellular carcinoma (HCC)<\/a>, a form of liver cancer. Although, the company believes that in no way the gene therapy could have caused HCC, and the outcome in this particular situation is due to him being at high risk for liver cancer with a long history of hepatitis C, hepatitis B virus, findings of non-alcoholic fatty liver disease and advanced age.<\/p>\n\n\n\n<p>The trial was investigating <strong>etranacogene dezaparvovec<\/strong> (<strong>AMT-061<\/strong>). It substantially increased the production of the blood-clotting protein factor IX, which is the factor missing for hemophilia B patients, in all the enrolled patients. The Hemophilia B market has several therapies, however, no therapy has been able to kill the disease from its root. Although, stumble-prone, gene therapies offer a bright leeway to target these diseases, where the company was taking its chances. However, there lies still hope as the clinical hold, it seems, will not affect the pivotal trial results as the dosing of the patients is completed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Ultragenyx_Pharmaceutical_Teams_up_with_Mereo_BioPharma_for_a_Bone_Disease_Candidate\"><\/span><strong>Ultragenyx Pharmaceutical Teams up with Mereo BioPharma for a Bone Disease Candidate<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Ultragenyx (RARE) and Mereo collaborated to develop and commercialize <strong>setrusumab<\/strong>, a monoclonal antibody for a rare genetic disorder <a href=\"https:\/\/www.delveinsight.com\/report-store\/osteogenesis-imperfecta-oi-market\" target=\"_blank\" rel=\"noreferrer noopener\">osteogenesis imperfecta <\/a>(OI). It is a heritable disorder of bone formation resulting in low bone mass and an increased propensity to fracture.<\/p>\n\n\n\n<p>A Phase IIb study &#8211; ASTEROID &#8211; which tested setrusumab in 90 adults with OI types I, III, and IV across three dose groups for 12 months, demonstrated improvements in bone mineral density at several anatomical sites on a dose-dependent basis. The company also mentioned that the drug is able to reduce the fractures at the highest dose as compared to lower ones.&nbsp;<\/p>\n\n\n\n<p>As per the deal, Ultragenyx is paying USD50 million upfront along with up to USD254 million in milestones payments. It will undertake the development of the drug as well as its marketing worldwide (except for Europe, where Mereo has the marketing rights).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"aTyr_Pharma_Completes_Enrollment_in_Phase_1b2a_Pulmonary_Sarcoidosis_Clinical_Trial_Testing_ATYR1923\"><\/span><strong>aTyr Pharma Completes Enrollment in Phase 1b\/2a Pulmonary Sarcoidosis Clinical Trial Testing ATYR1923&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>aTyr Pharma announced that the company has completed the target enrollment of 36 patients in its Phase 1b\/2a clinical trial aimed at evaluating its lead candidate, <strong>ATYR1923<\/strong>, for pulmonary sarcoidosis, a form of interstitial lung disease (ILD).&nbsp;<\/p>\n\n\n\n<p>Sarcoidosis is a rare condition that leads to the development of small patches of red and swollen tissue, called granulomas in the organs, usually affecting the lungs and skin. Sarcoidosis in the lungs is called <a href=\"https:\/\/www.delveinsight.com\/report-store\/pulmonary-sarcoidosis-market\" target=\"_blank\" rel=\"noreferrer noopener\">Pulmonary Sarcoidosis<\/a>. The present treatment regimen for this multisystem disorder is to prevent or control organ damage, relieve symptoms, and improve the patient&#8217;s quality of life.<\/p>\n\n\n\n<p>aTyr Pharma\u2019s ATYR1923 works by selectively modulating NRP2 to downregulate the innate and adaptive immune response in inflammatory disease states and is in undergoing trial. The company plans to report data from this trial in the third quarter of 2021.&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Servier Acquires Agios&#8217; Cancer Portfolio in a USD 2 Billion Deal The year is a prime witness of pricey deals and acquisitions in the pharmaceutical industry. To leave its mark, another player decided to hop onto the list. French drugmaker Servier has announced the acquisition of the Oncology business of Agios Pharmaceutical in a deal [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":11486,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[137,5996,16804],"industry":[17225],"therapeutic_areas":[17228],"class_list":["post-11483","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-cancer","tag-hepatocellular-carcinoma","tag-pulmonary-sarcoidosis","industry-pharmaceutical","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>uniQure\u2019s gene therapy; Ultragenyx, Mereo Deal; aTyr Pharma Trial<\/title>\n<meta name=\"description\" content=\"Agios&#039; cancer pipeline auction; uniQure\u2019s gene therapy on hold; Ultragenyx, Mere Deal; aTyr Pharma Pulmonary Sarcoidosis Trial\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-fo-agios-uniqures-ultragenyx-mereo-atyr-pharma\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"uniQure\u2019s gene therapy; Ultragenyx, Mereo Deal; aTyr Pharma Trial\" \/>\n<meta property=\"og:description\" content=\"Agios&#039; cancer pipeline auction; uniQure\u2019s gene therapy on hold; Ultragenyx, Mere Deal; aTyr Pharma Pulmonary Sarcoidosis Trial\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.delveinsight.com\/blog\/pharma-happenings-fo-agios-uniqures-ultragenyx-mereo-atyr-pharma\" \/>\n<meta property=\"og:site_name\" content=\"DelveInsight Business Research\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/\" \/>\n<meta property=\"article:published_time\" content=\"2020-12-22T11:25:10+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-07-24T07:28:12+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2020\/12\/22165251\/Agios-cancer-pipeline-auction-uniQure%E2%80%99s-gene-therapy-on-hold-Ultragenyx-Mereo-Deal-aTyr-Pharma-Trial.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"772\" \/>\n\t<meta property=\"og:image:height\" content=\"482\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Sandeep Joshi\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:site\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Sandeep Joshi\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"uniQure\u2019s gene therapy; 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uniQure\u2019s gene therapy on hold; Ultragenyx, Mereo Deal; aTyr Pharma Trial"},{"@type":"WebSite","@id":"https:\/\/www.delveinsight.com\/blog\/#website","url":"https:\/\/www.delveinsight.com\/blog\/","name":"DelveInsight Business Research","description":"Blog","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.delveinsight.com\/blog\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/f1eefd8dd4afdb0617d6166f8b301e0a","name":"Sandeep Joshi","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/7676451175fe155887a18ffb50e674b270d87436a3fc34ca206f86921cddf4cd?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/7676451175fe155887a18ffb50e674b270d87436a3fc34ca206f86921cddf4cd?s=96&d=mm&r=g","caption":"Sandeep Joshi"},"sameAs":["http:\/\/Delveinsight.com"]}]}},"author_meta":{"display_name":"Sandeep Joshi","author_link":"https:\/\/www.delveinsight.com\/blog\/author\/sjoshidelveinsight-com"},"featured_img":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2020\/12\/22165251\/Agios-cancer-pipeline-auction-uniQure%E2%80%99s-gene-therapy-on-hold-Ultragenyx-Mereo-Deal-aTyr-Pharma-Trial-300x187.jpg","coauthors":[],"tax_additional":{"categories":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Cancer<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Hepatocellular Carcinoma<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Pulmonary Sarcoidosis<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Cancer<\/span>","<span class=\"advgb-post-tax-term\">Hepatocellular Carcinoma<\/span>","<span class=\"advgb-post-tax-term\">Pulmonary Sarcoidosis<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 5 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on Dec 22, 2020","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Dec 22, 2020 4:55 pm","modified":"Updated on Jul 24, 2021 12:58 pm"},"featured_img_caption":"Agios' cancer pipeline auction; 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