{"id":32669,"date":"2025-07-08T14:00:52","date_gmt":"2025-07-08T08:30:52","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=32669"},"modified":"2025-07-08T14:00:53","modified_gmt":"2025-07-08T08:30:53","slug":"pharma-news-for-merck-kalvista-mustang","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-merck-kalvista-mustang","title":{"rendered":"Merck\u2019s WINREVAIR Granted FDA Priority Review for Pulmonary Arterial Hypertension; KalVista\u2019s EKTERLY Approved by FDA as First Oral On-Demand Therapy for Hereditary Angioedema; Fujifilm\u2019s FF-10832 Receives FDA Orphan Drug Designation for Biliary Tract Cancer; Mustang Bio\u2019s MB-101 Granted FDA Orphan Drug Designation for Glioblastoma and Astrocytomas; Denali\u2019s Tividenofusp Alfa Accepted for FDA Priority Review for Hunter Syndrome"},"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-69dc7377cc9ea\" 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-69dc7377cc9ea\"  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-news-for-merck-kalvista-mustang\/#Mercks_WINREVAIR_Gets_FDA_Priority_Review_for_Pulmonary_Arterial_Hypertension\" >Merck&#8217;s WINREVAIR Gets FDA Priority Review for Pulmonary Arterial Hypertension<\/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-news-for-merck-kalvista-mustang\/#KalVistas_EKTERLY_Approved_by_FDA_as_First_Oral_On-Demand_HAE_Treatment\" >KalVista&#8217;s EKTERLY Approved by FDA as First Oral On-Demand HAE Treatment<\/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-news-for-merck-kalvista-mustang\/#FDA_Grants_Orphan_Drug_Status_to_Fujifilms_FF-10832_for_Biliary_Tract_Cancer\" >FDA Grants Orphan Drug Status to Fujifilm\u2019s FF-10832 for Biliary Tract Cancer<\/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-news-for-merck-kalvista-mustang\/#Mustang_Bios_MB-101_Receives_FDA_Orphan_Drug_Designation_for_Glioblastoma\" >Mustang Bio\u2019s MB-101 Receives FDA Orphan Drug Designation for Glioblastoma<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-merck-kalvista-mustang\/#Denalis_Tividenofusp_Alfa_Gets_FDA_Priority_Review_for_Hunter_Syndrome_MPS_II\" >Denali\u2019s Tividenofusp Alfa Gets FDA Priority Review for Hunter Syndrome (MPS II)<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-merck-s-winrevair-gets-fda-priority-review-for-pulmonary-arterial-hypertension\"><span class=\"ez-toc-section\" id=\"Mercks_WINREVAIR_Gets_FDA_Priority_Review_for_Pulmonary_Arterial_Hypertension\"><\/span>Merck&#8217;s WINREVAIR Gets FDA Priority Review for Pulmonary Arterial Hypertension<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Merck,<\/strong> also known as<strong> MSD outside <\/strong>the U.S. and Canada, announced that the FDA has accepted and granted Priority Review to the supplemental Biologics License Application (sBLA) for <strong>WINREVAIR (sotatercept-csrk)<\/strong>. The application seeks to update the drug\u2019s U.S. label based on findings from the Phase III ZENITH trial in <a href=\"https:\/\/www.delveinsight.com\/report-store\/pulmonary-arterial-hypertension-market\"><strong>pulmonary arterial hypertension (PAH, Group 1 PH<\/strong><\/a><strong>)<\/strong>. The FDA has set the Prescription Drug User Fee Act (PDUFA) action date for October 25, 2025.<\/p>\n\n\n\n<p>In the ZENITH trial, WINREVAIR showed a 76% reduction in the risk of a composite of all-cause death, lung transplantation, or PAH-related hospitalization compared to placebo. The study was notably the first PAH Phase III trial to be stopped early by an independent data monitoring committee due to overwhelming efficacy. These findings were recently published in the <em>New England Journal of Medicine<\/em>.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWe are pleased that the FDA has accepted our sBLA and granted a Priority Review to include the impressive results of ZENITH,\u201d said Dr. Joerg Koglin, Senior Vice President, Global Clinical Development, Merck Research Laboratories. \u201cThere remains a significant unmet medical need for patients living with PAH who, despite background therapy, remain at high risk.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>WINREVAIR was approved in 2024 for the treatment of adults with PAH to improve exercise capacity, WHO functional class, and reduce clinical worsening. It is currently approved in over 45 countries based on data from the STELLAR trial.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-kalvista-s-ekterly-approved-by-fda-as-first-oral-on-demand-hae-treatment\"><span class=\"ez-toc-section\" id=\"KalVistas_EKTERLY_Approved_by_FDA_as_First_Oral_On-Demand_HAE_Treatment\"><\/span>KalVista&#8217;s EKTERLY Approved by FDA as First Oral On-Demand HAE Treatment<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>KalVista Pharmaceuticals<\/strong> announced FDA approval of <strong>EKTERLY (sebetralstat)<\/strong>, the first and only oral on-demand therapy for the treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/hereditary-angioedema-market\"><strong>acute hereditary angioedema (HAE)<\/strong><\/a> attacks in patients aged 12 years and older. This marks the first new on-demand HAE treatment approved in over a decade and offers a potentially transformative option for patients, particularly those burdened by injectable therapies.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe FDA approval of EKTERLY is a defining moment for people living with HAE,\u201d said <\/em><strong><em>Ben Palleiko<\/em><\/strong><em>, CEO of KalVista. \u201cEKTERLY enables people to treat attacks the moment symptoms begin, wherever they are\u2026 EKTERLY has the potential to become the foundational treatment for HAE.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Previously, all approved on-demand HAE treatments in the U.S. required intravenous or subcutaneous administration, often delaying response. EKTERLY, a plasma kallikrein inhibitor, offers a rapid, convenient oral option that may enhance treatment timing and patient independence.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cAs the first orally administered on-demand therapy for HAE attacks, EKTERLY provides patients and physicians with an important and welcome advance,\u201d said <\/em><strong><em>Anthony J. Castaldo<\/em><\/strong><em>, CEO of the U.S. Hereditary Angioedema Association.<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Data from KalVista\u2019s <strong>phase III KONFIDENT trial<\/strong>, the largest HAE trial to date\u2014demonstrated EKTERLY\u2019s rapid symptom relief, reduced severity, and favorable safety profile. The trial randomized 136 patients across 66 sites in 20 countries and showed a significantly faster response compared to placebo. These results were supported by the ongoing KONFIDENT-S extension study, in which patients reported treating attacks within a median of 10 minutes and consistent efficacy across all attack locations, including those involving the larynx.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis is an important moment for patients,\u201d said <\/em><strong><em>Dr. Marc A. Riedl<\/em><\/strong><em>, Professor of Medicine at UC San Diego. \u201cHaving an oral option empowers patients to treat early, aligning with current treatment goals.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>KalVista will begin the U.S. launch of EKTERLY immediately, supported by the <strong>KalVista Cares\u2122<\/strong> program offering access and reimbursement support.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-grants-orphan-drug-status-to-fujifilm-s-ff-10832-for-biliary-tract-cancer\"><span class=\"ez-toc-section\" id=\"FDA_Grants_Orphan_Drug_Status_to_Fujifilms_FF-10832_for_Biliary_Tract_Cancer\"><\/span>FDA Grants Orphan Drug Status to Fujifilm\u2019s FF-10832 for Biliary Tract Cancer<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>FUJIFILM Pharmaceuticals U.S.A., Inc. <\/strong>has announced that the FDA has granted <strong>orphan drug designation<\/strong> to <strong>FF-10832<\/strong>, an investigational liposomal formulation of gemcitabine, for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/biliary-tract-cancers-btcs-market\">treatment of <strong>biliary tract cancer (BTC)<\/strong><\/a>. FF-10832 is currently being evaluated in a phase IIa trial (NCT05318573) as monotherapy and in combination with pembrolizumab for solid tumors.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cBTCs are rare but aggressive malignancies associated with a poor prognosis and limited treatment options,\u201d said Susumu Shimoyama, President of FUJIFILM Pharmaceuticals U.S.A., Inc. \u201cReceiving orphan drug designation highlights the significant unmet medical need and supports the development of FF-10832 for patients who have few satisfactory options.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>With approximately 16,000 new BTC cases reported annually in the U.S., the majority are diagnosed at unresectable or metastatic stages, and existing therapies like surgery and chemotherapy offer limited efficacy. Gemcitabine remains a cornerstone of BTC treatment, and FF-10832\u2019s liposomal formulation is designed to prolong plasma half-life and improve tumor targeting for enhanced anti-cancer activity.<\/p>\n\n\n\n<p>The FDA\u2019s orphan drug designation is intended to promote therapies for rare diseases, offering benefits like seven years of marketing exclusivity and potential financial incentives. Fujifilm\u2019s CDMO capabilities, through FUJIFILM Toyama Chemical, ensure end-to-end development and manufacturing. The company also holds orphan drug designations for two other candidates\u2014FF-10502 and FF-10850\u2014for cholangiocarcinoma and Merkel cell carcinoma, respectively.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-mustang-bio-s-mb-101-receives-fda-orphan-drug-designation-for-glioblastoma\"><span class=\"ez-toc-section\" id=\"Mustang_Bios_MB-101_Receives_FDA_Orphan_Drug_Designation_for_Glioblastoma\"><\/span>Mustang Bio\u2019s MB-101 Receives FDA Orphan Drug Designation for Glioblastoma<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Mustang Bio announced that the FDA has granted <strong>Orphan Drug Designation<\/strong> to its IL13Ra2-targeted <strong>CAR T-cell therapy, MB-101<\/strong>, for the treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/anaplastic-astrocytoma-market\"><strong>recurrent diffuse and anaplastic astrocytomas<\/strong><\/a><strong> and <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/glioblastoma-market\"><strong>glioblastoma (GBM)<\/strong><\/a>. This designation adds to the previously granted Orphan status for <strong>MB-108<\/strong>, Mustang\u2019s HSV-1 oncolytic virus, reinforcing the company\u2019s dual-therapy approach in difficult-to-treat brain cancers.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWe are thrilled that MB-101 received Orphan Drug Designation with a broader indication than initially proposed,\u201d said Manuel Litchman, M.D., President and CEO of Mustang Bio. \u201cThis, along with MB-108\u2019s designation, validates our science and highlights the potential of combining CAR T-cell therapy with an oncolytic virus to reshape the tumor microenvironment and improve outcomes for patients with malignant glioma.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>In a phase I trial conducted at City of Hope and published in <em>Nature Medicine<\/em> in 2024, MB-101 demonstrated encouraging clinical benefit, with 50% of patients achieving stable disease or better, including two complete responses lasting over 7.5 and 66+ months, respectively. These results were associated with tumors exhibiting high pre-treatment levels of CD3+ T cells, classified as \u201chot\u201d tumors.<\/p>\n\n\n\n<p>Preclinical data and findings presented at the 2022 AACR Annual Meeting support a <strong>combination strategy with MB-108 (oncolytic virus) and MB-101<\/strong>, aiming to convert immunologically \u201ccold\u201d tumors into \u201chot\u201d ones to enhance CAR T-cell efficacy. Both MB-101 and MB-108 monotherapies were reported to be well-tolerated in clinical studies. Ongoing trials for MB-101 and MB-108 are continuing at City of Hope and the University of Alabama at Birmingham, respectively.<\/p>\n\n\n\n<p>Mustang Bio stated that continued progress in its <strong>MB-109 program<\/strong> (MB-101 + MB-108) for GBM and high-grade astrocytomas will depend on securing additional funding or strategic partnerships.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-denali-s-tividenofusp-alfa-gets-fda-priority-review-for-hunter-syndrome-mps-ii\"><span class=\"ez-toc-section\" id=\"Denalis_Tividenofusp_Alfa_Gets_FDA_Priority_Review_for_Hunter_Syndrome_MPS_II\"><\/span>Denali\u2019s Tividenofusp Alfa Gets FDA Priority Review for Hunter Syndrome (MPS II)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Denali Therapeutics announced that the FDA has accepted and granted <strong>Priority Review<\/strong> to its <strong>Biologics License Application (BLA)<\/strong> for <strong>tividenofusp alfa<\/strong>, a next-generation enzyme replacement therapy for <a href=\"https:\/\/www.delveinsight.com\/report-store\/hunter-syndrome-market\"><strong>Hunter syndrome (MPS II)<\/strong><\/a>. The agency has assigned a <strong>PDUFA target action date of January 5, 2026<\/strong>, as part of an accelerated approval pathway.<\/p>\n\n\n\n<p>Tividenofusp alfa is engineered using Denali\u2019s proprietary <strong>TransportVehicle\u2122 platform<\/strong> to deliver the missing <strong>iduronate 2-sulfatase (IDS)<\/strong> enzyme both throughout the body and across the <strong>blood-brain barrier<\/strong>\u2014a crucial advancement, given that existing therapies cannot reach the brain and fail to address the neurological symptoms of the disease.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWe are grateful to the FDA for their recognition of the urgent need for new therapies that could offer a significant improvement in the treatment of Hunter syndrome,\u201d said Carole Ho, M.D., Chief Medical Officer and Head of Development at Denali. \u201cIf approved, tividenofusp alfa would be the first major advancement in nearly two decades for individuals living with this devastating disease, offering the potential to treat both cognitive and physical symptoms.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The BLA is supported by results from an open-label phase I\/II study involving 47 participants with Hunter syndrome, and the company is continuing its ongoing phase II\/III COMPASS study to support global regulatory submissions. Denali is also actively preparing for a potential commercial launch in the U.S. while continuing to expand its TransportVehicle-enabled pipeline targeting lysosomal storage diseases and neurodegenerative conditions.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Merck&#8217;s WINREVAIR Gets FDA Priority Review for Pulmonary Arterial Hypertension Merck, also known as MSD outside the U.S. and Canada, announced that the FDA has accepted and granted Priority Review to the supplemental Biologics License Application (sBLA) for WINREVAIR (sotatercept-csrk). The application seeks to update the drug\u2019s U.S. label based on findings from the Phase [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":32670,"comment_status":"closed","ping_status":"closed","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":[16752,16751,21478,204,704,1787,1270,2483,21855,303,12926,349,420,639,499,17980,4074],"industry":[17225],"therapeutic_areas":[17242,17240,17238,17228],"class_list":["post-32669","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-biliary-tract-cancer","tag-biliary-tract-cancer-market","tag-biliary-tract-cancer-treatment","tag-delveinsight","tag-fda","tag-glioblastoma","tag-hereditary-angioedema","tag-hereditary-angioedema-hae","tag-hereditary-angioedema-market","tag-hunter-syndrome","tag-hunter-syndrome-market","tag-latest-pharma-news","tag-news","tag-pharma-news","tag-pulmonary-arterial-hypertension","tag-pulmonary-arterial-hypertension-drugs","tag-pulmonary-arterial-hypertension-market-forecast","industry-pharmaceutical","therapeutic_areas-cardiovascular-diseases","therapeutic_areas-endocrinology-and-metabolic-disorders","therapeutic_areas-genetic-disorders","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>Pharma News | Merck, KalVista, Mustang<\/title>\n<meta name=\"description\" content=\"Merck\u2019s WINREVAIR; KalVista\u2019s EKTERLY; Fujifilm\u2019s FF-10832; Mustang Bio\u2019s MB-101; Denali\u2019s Tividenofusp Alfa\" \/>\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-news-for-merck-kalvista-mustang\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Merck, KalVista, Mustang\" \/>\n<meta property=\"og:description\" content=\"Merck\u2019s WINREVAIR; KalVista\u2019s EKTERLY; Fujifilm\u2019s FF-10832; Mustang Bio\u2019s MB-101; Denali\u2019s Tividenofusp Alfa\" \/>\n<meta property=\"og:url\" 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