{"id":33186,"date":"2025-08-26T18:19:56","date_gmt":"2025-08-26T12:49:56","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=33186"},"modified":"2025-09-17T12:52:51","modified_gmt":"2025-09-17T07:22:51","slug":"madrigal-wins-eu-approval-for-rezdiffra-in-mash-with-liver-fibrosis-valneva-faces-fda-license-suspension-for-chikungunya-vaccine-ixchiq-coya-secures-fda-ind-clearance-for-coya-302-in-als-treatment","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/madrigal-wins-eu-approval-for-rezdiffra-in-mash-with-liver-fibrosis-valneva-faces-fda-license-suspension-for-chikungunya-vaccine-ixchiq-coya-secures-fda-ind-clearance-for-coya-302-in-als-treatment","title":{"rendered":"Madrigal Wins EU Approval for REZDIFFRA in MASH With Liver Fibrosis; Valneva Faces FDA License Suspension for Chikungunya Vaccine IXCHIQ; Coya Secures FDA IND Clearance for COYA 302 in ALS Treatment; Rusfertide Earns FDA Breakthrough Therapy Designation for Polycythemia Vera; Crinetics Gains FDA Orphan Drug Status for Atumelnant in Congenital Adrenal Hyperplasia"},"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-69e058bad722c\" 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-69e058bad722c\"  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\/madrigal-wins-eu-approval-for-rezdiffra-in-mash-with-liver-fibrosis-valneva-faces-fda-license-suspension-for-chikungunya-vaccine-ixchiq-coya-secures-fda-ind-clearance-for-coya-302-in-als-treatment\/#Madrigal_Wins_EU_Approval_For_REZDIFFRA_In_MASH_With_Liver_Fibrosis\" >Madrigal Wins EU Approval For REZDIFFRA In MASH With Liver Fibrosis<\/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\/madrigal-wins-eu-approval-for-rezdiffra-in-mash-with-liver-fibrosis-valneva-faces-fda-license-suspension-for-chikungunya-vaccine-ixchiq-coya-secures-fda-ind-clearance-for-coya-302-in-als-treatment\/#Valneva_Faces_FDA_License_Suspension_For_Chikungunya_Vaccine_IXCHIQ\" >Valneva Faces FDA License Suspension For Chikungunya Vaccine IXCHIQ<\/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\/madrigal-wins-eu-approval-for-rezdiffra-in-mash-with-liver-fibrosis-valneva-faces-fda-license-suspension-for-chikungunya-vaccine-ixchiq-coya-secures-fda-ind-clearance-for-coya-302-in-als-treatment\/#Coya_Secures_FDA_IND_Clearance_For_COYA_302_In_ALS_Treatment\" >Coya Secures FDA IND Clearance For COYA 302 In ALS Treatment<\/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\/madrigal-wins-eu-approval-for-rezdiffra-in-mash-with-liver-fibrosis-valneva-faces-fda-license-suspension-for-chikungunya-vaccine-ixchiq-coya-secures-fda-ind-clearance-for-coya-302-in-als-treatment\/#Rusfertide_Earns_FDA_Breakthrough_Therapy_Designation_For_Polycythemia_Vera\" >Rusfertide Earns FDA Breakthrough Therapy Designation For Polycythemia Vera<\/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\/madrigal-wins-eu-approval-for-rezdiffra-in-mash-with-liver-fibrosis-valneva-faces-fda-license-suspension-for-chikungunya-vaccine-ixchiq-coya-secures-fda-ind-clearance-for-coya-302-in-als-treatment\/#Crinetics_Gains_FDA_Orphan_Drug_Status_For_Atumelnant_In_Congenital_Adrenal_Hyperplasia\" >Crinetics Gains FDA Orphan Drug Status For Atumelnant In Congenital Adrenal Hyperplasia<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.delveinsight.com\/blog\/madrigal-wins-eu-approval-for-rezdiffra-in-mash-with-liver-fibrosis-valneva-faces-fda-license-suspension-for-chikungunya-vaccine-ixchiq-coya-secures-fda-ind-clearance-for-coya-302-in-als-treatment\/#Pharma_News_Roundup_FDA_Moves_EU_Approvals_Trial_Updates\" >Pharma News Roundup: FDA Moves, EU Approvals &amp; Trial Updates<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-madrigal-wins-eu-approval-for-rezdiffra-in-mash-with-liver-fibrosis\"><span class=\"ez-toc-section\" id=\"Madrigal_Wins_EU_Approval_For_REZDIFFRA_In_MASH_With_Liver_Fibrosis\"><\/span>Madrigal Wins EU Approval For REZDIFFRA In MASH With Liver Fibrosis<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Madrigal Pharmaceuticals<\/strong> announced that the European Commission (EC) has granted conditional marketing authorization for <strong>REZDIFFRA<\/strong>, the first and only approved therapy in the European Union (EU) for adults with <a href=\"https:\/\/www.delveinsight.com\/report-store\/metabolic-dysfunction-associated-steatohepatitis-mash-market\">noncirrhotic<strong> metabolic dysfunction-associated steatohepatitis (MASH)<\/strong><\/a><strong> <\/strong>with <a href=\"https:\/\/www.delveinsight.com\/report-store\/liver-fibrosis-market\">moderate to advanced<strong> liver fibrosis<\/strong><\/a>. The approval follows a positive CHMP opinion in June 2025 and is valid across all 27 EU Member States, as well as Iceland, Liechtenstein, and Norway.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis approval of REZDIFFRA marks a historic breakthrough for patients in Europe living with MASH, a serious and progressive liver disease,\u201d said <\/em><strong><em>Bill Sibold, CEO of Madrigal<\/em><\/strong><em>. \u201cThe European labelling will set an important precedent, with no biopsy required to qualify for treatment and a clear focus on patients with moderate to advanced fibrosis (F2-F3), who are at significantly higher risk of liver-related mortality.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The EC\u2019s decision was based on results from the pivotal <strong>phase III MAESTRO-NASH trial<\/strong>, where REZDIFFRA met both primary endpoints of fibrosis reduction and MASH resolution. The therapy also improved liver stiffness, fat, enzymes, and lipids, while enhancing quality of life. At one year, 91% of patients on REZDIFFRA 100 mg achieved improvement or stabilization of liver stiffness.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em><strong>Frank Tacke, MD, PhD, Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin<\/strong>, stated: \u201cThe approval of REZDIFFRA is a transformational moment for the European MASH community. It is already included in European treatment guidelines, and with hundreds of patients enrolled in phase III studies, there is strong clinical experience supporting its use.\u201d Madrigal plans to launch REZDIFFRA in Germany in Q4 2025, with broader rollout subject to national reimbursement decisions.<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-valneva-faces-fda-license-suspension-for-chikungunya-vaccine-ixchiq\"><span class=\"ez-toc-section\" id=\"Valneva_Faces_FDA_License_Suspension_For_Chikungunya_Vaccine_IXCHIQ\"><\/span>Valneva Faces FDA License Suspension For Chikungunya Vaccine IXCHIQ<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Valneva SE<\/strong> announced that the FDA has suspended the U.S. license for <strong>IXCHIQ<\/strong>, its<strong> <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/chikungunya-market\"><strong>chikungunya vaccine<\/strong><\/a>, after four new serious adverse events (SAEs) resembling chikungunya-like illness were reported. The suspension is effective immediately, requiring the company to halt shipments and sales in the U.S.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis decision comes as the global threat of chikungunya continues to escalate,\u201d said <\/em><strong><em>Thomas Lingelbach, CEO of Valneva<\/em><\/strong><em>. \u201cWe remain fully committed to maintaining access to IXCHIQ as a global health tool, particularly in endemic regions, and will continue working with partners to ensure the vaccine reaches those most in need.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The move follows an earlier FDA action in August 2025 to lift a recommended pause on IXCHIQ use in people over 60, but updated VAERS data, including four additional SAEs outside the U.S., prompted a full license suspension. Three of the cases involved elderly patients aged 70\u201382, and one in a 55-year-old. Valneva stated these events are consistent with safety observations from clinical trials and post-marketing experience, particularly in older individuals with underlying conditions.<\/p>\n\n\n\n<p>Valneva is assessing the potential financial impact of a permanent withdrawal but has not changed its revenue guidance. IXCHIQ generated <strong>\u20ac7.5 million<\/strong> of the company\u2019s \u20ac91 million product sales in H1 2025, largely from emergency vaccine deliveries to La R\u00e9union during a chikungunya outbreak.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-coya-secures-fda-ind-clearance-for-coya-302-in-als-treatment\"><span class=\"ez-toc-section\" id=\"Coya_Secures_FDA_IND_Clearance_For_COYA_302_In_ALS_Treatment\"><\/span>Coya Secures FDA IND Clearance For COYA 302 In ALS Treatment<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Coya Therapeutics<\/strong> announced that the FDA has accepted its Investigational New Drug (IND) application for <strong>COYA 302<\/strong>, a proprietary immunomodulatory biologic combination therapy for <a href=\"https:\/\/www.delveinsight.com\/report-store\/amyotrophic-lateral-sclerosis-als-market\"><strong>amyotrophic lateral sclerosis (ALS)<\/strong><\/a>. The clearance enables the initiation of a multicenter, double-blind, placebo-controlled <strong>phase II trial<\/strong> to evaluate the therapy\u2019s safety and efficacy.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe FDA&#8217;s acceptance of this IND marks a pivotal moment in Coya&#8217;s journey,\u201d said <\/em><strong><em>Arun Swaminathan, CEO of Coya<\/em><\/strong><em>. \u201cWe are now preparing to initiate a well-powered phase II study and are grateful to the ALS community for their continued support of this important program.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><strong><em>Milan Kalawadia, CEO North America at Dr. Reddy&#8217;s Laboratories (DRL)<\/em><\/strong><em>, added: \u201cThis milestone further reinforces the strong scientific and strategic rationale behind our partnership with Coya. We are energized by the potential of COYA 302 as we move closer to offering a treatment for patients living with ALS.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The IND approval also triggers a <strong>$4.2 million milestone payment<\/strong> from DRL to Coya, supporting advancement of the program.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-rusfertide-earns-fda-breakthrough-therapy-designation-for-polycythemia-vera\"><span class=\"ez-toc-section\" id=\"Rusfertide_Earns_FDA_Breakthrough_Therapy_Designation_For_Polycythemia_Vera\"><\/span>Rusfertide Earns FDA Breakthrough Therapy Designation For Polycythemia Vera<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Protagonist Therapeutics<\/strong> announced that the FDA has granted <strong>Breakthrough Therapy Designation<\/strong> to <strong>rusfertide<\/strong>, a potential first-in-class hepcidin-mimetic peptide, for the treatment of erythrocytosis in patients with <a href=\"https:\/\/www.delveinsight.com\/report-store\/polycythemia-vera-market\"><strong>polycythemia vera (PV)<\/strong><\/a>. The designation builds on the therapy\u2019s <strong>Orphan Drug<\/strong> and <strong>Fast Track<\/strong> statuses, offering multiple regulatory and development benefits.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWe are very pleased with the FDA&#8217;s decision, which underscores the potential of RUSFERTIDE to deliver substantial improvement over current PV therapies,\u201d said <\/em><strong><em>Dinesh V. Patel, Ph.D., President and CEO of Protagonist<\/em><\/strong><em>. \u201cWe remain on track to submit an NDA for RUSFERTIDE by the end of this year.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The FDA decision was supported by positive <strong>phase III VERIFY trial<\/strong> data, presented during the plenary session at the 2025 ASCO Annual Meeting. The 32-week results highlighted RUSFERTIDE\u2019s ability to achieve hematocrit control, reduce phlebotomy dependence, and improve patient-reported outcomes including fatigue.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe comprehensive data provide compelling evidence of RUSFERTIDE\u2019s ability to address unmet needs in PV,\u201d added <\/em><strong><em>Arturo Molina, M.D., M.S., CMO of Protagonist<\/em><\/strong><em>. The therapy is being co-developed with Takeda Pharmaceuticals under a global collaboration agreement, with Protagonist leading development through NDA filing.<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-crinetics-gains-fda-orphan-drug-status-for-atumelnant-in-congenital-adrenal-hyperplasia\"><span class=\"ez-toc-section\" id=\"Crinetics_Gains_FDA_Orphan_Drug_Status_For_Atumelnant_In_Congenital_Adrenal_Hyperplasia\"><\/span>Crinetics Gains FDA Orphan Drug Status For Atumelnant In Congenital Adrenal Hyperplasia<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Crinetics Pharmaceuticals<\/strong> announced that the FDA has granted <strong>Orphan Drug Designation (ODD)<\/strong> to <strong>Atumelnant<\/strong>, the first and only small-molecule ACTH receptor antagonist in clinical development, for the treatment of classic <a href=\"https:\/\/www.delveinsight.com\/report-store\/congenital-adrenal-hyperplasia-market\"><strong>congenital adrenal hyperplasia (CAH)<\/strong><\/a>. The designation provides key regulatory and financial incentives, including seven years of market exclusivity upon approval.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis designation underscores the significant unmet need faced by patients with CAH,\u201d said <\/em><strong><em>Dana Pizzuti, M.D., Chief Medical and Development Officer at Crinetics<\/em><\/strong><em>. \u201cAtumelnant\u2019s novel mechanism offers the potential to restore adrenal androgen balance, reduce glucocorticoid supplementation, and meaningfully improve patients\u2019 quality of life.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The decision builds on strong results from the <strong>phase II TouCAHn trial<\/strong>, which showed rapid and sustained biomarker improvements, including up to an 80% reduction in androstenedione, along with clinical benefits such as resumption of menses and reduced adrenal size. Crinetics expects to begin enrolling participants in the <strong>CALM-CAH phase III trial<\/strong> in adults and the <strong>BALANCE-CAH phase II\/III trial<\/strong> in pediatrics in the second half of 2025.<\/p>\n\n\n\n<p>Classic CAH, caused by impaired cortisol synthesis, remains an area of high unmet need. Current treatments rely on chronic glucocorticoid supplementation, often at supraphysiologic levels, leading to complications such as diabetes, cardiovascular disease, and osteoporosis. Crinetics aims for ATUMELNANT to provide a safer, more targeted approach to long-term disease management.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-pharma-news-roundup-fda-moves-eu-approvals-amp-trial-updates\"><span class=\"ez-toc-section\" id=\"Pharma_News_Roundup_FDA_Moves_EU_Approvals_Trial_Updates\"><\/span>Pharma News Roundup: FDA Moves, EU Approvals &amp; Trial Updates<span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<p>So, this was the pharma news \u2014 <strong>Madrigal\u2019s REZDIFFRA<\/strong> won EU conditional approval for MASH with fibrosis; <strong>Valneva\u2019s IXCHIQ<\/strong> had its U.S. license suspended after new SAE reports; <strong>Coya\u2019s COYA 302<\/strong> IND was accepted in ALS, enabling a phase II trial and a $4.2M milestone; <strong>Protagonist\u2019s RUSFERTIDE<\/strong> earned FDA Breakthrough Therapy in PV on phase III VERIFY data; and <strong>Crinetics\u2019 ATUMELNANT<\/strong> received FDA Orphan Drug status in CAH with pivotal starts slated for H2 2025. Net-net: major regulatory wins, one safety setback, and multiple catalysts advancing toward late-stage development.<\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Madrigal Wins EU Approval For REZDIFFRA In MASH With Liver Fibrosis Madrigal Pharmaceuticals announced that the European Commission (EC) has granted conditional marketing authorization for REZDIFFRA, the first and only approved therapy in the European Union (EU) for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis. The approval follows a [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":33187,"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":[74,19150,19151,19148,21167,21511,21512,19635,19640,19636,204,704,349,22318,22320,22319,420,639,19101,20436,20440,5789],"industry":[17225],"therapeutic_areas":[17240,17239,17233,17231,17245],"class_list":["post-33186","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-amyotrophic-lateral-sclerosis","tag-amyotrophic-lateral-sclerosis-clinical-trials","tag-amyotrophic-lateral-sclerosis-emerging-drugs","tag-amyotrophic-lateral-sclerosis-treatment","tag-chikungunya","tag-chikungunya-treatment","tag-chikungunya-vaccine","tag-congenital-adrenal-hyperplasia","tag-congenital-adrenal-hyperplasia-clinical-trials","tag-congenital-adrenal-hyperplasia-treatment","tag-delveinsight","tag-fda","tag-latest-pharma-news","tag-mash","tag-mash-treatment","tag-metabolic-dysfunction-associated-steatohepatitis","tag-news","tag-pharma-news","tag-polycythemia-vera","tag-polycythemia-vera-treatment","tag-polycythemia-vera-treatment-market","tag-recent-pharma-news","industry-pharmaceutical","therapeutic_areas-endocrinology-and-metabolic-disorders","therapeutic_areas-gastroenterology","therapeutic_areas-hematological-disorders","therapeutic_areas-infectious-diseases","therapeutic_areas-neurology"],"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>Madrigal Wins EU Approval for REZDIFFRA in MASH With Liver Fibrosis; Valneva Faces FDA License Suspension for Chikungunya Vaccine IXCHIQ; Coya Secures FDA IND Clearance for COYA 302 in ALS Treatment; Rusfertide Earns FDA Breakthrough Therapy Designation for Polycythemia Vera; Crinetics Gains FDA Orphan Drug Status for Atumelnant in Congenital Adrenal Hyperplasia - DelveInsight Business Research<\/title>\n<meta name=\"description\" content=\"Madrigal secures EU approval for REZDIFFRA targeting MASH with liver fibrosis, marking a major step in NASH therapy. Meanwhile, Valneva faces a setback as the FDA suspends its license for the chikungunya vaccine IXCHIQ. In ALS research, Coya achieves FDA IND clearance for COYA 302, advancing potential treatment options. Rusfertide gains FDA Breakthrough Therapy designation for polycythemia vera, accelerating its clinical development, while Crinetics earns FDA Orphan Drug status for Atumelnant in congenital adrenal hyperplasia, highlighting progress in rare disease therapeutics.\" \/>\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\/madrigal-wins-eu-approval-for-rezdiffra-in-mash-with-liver-fibrosis-valneva-faces-fda-license-suspension-for-chikungunya-vaccine-ixchiq-coya-secures-fda-ind-clearance-for-coya-302-in-als-treatment\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Madrigal Wins EU Approval for REZDIFFRA in MASH With Liver Fibrosis; Valneva Faces FDA License Suspension for Chikungunya Vaccine IXCHIQ; Coya Secures FDA IND Clearance for COYA 302 in ALS Treatment; Rusfertide Earns FDA Breakthrough Therapy Designation for Polycythemia Vera; Crinetics Gains FDA Orphan Drug Status for Atumelnant in Congenital Adrenal Hyperplasia - DelveInsight Business Research\" \/>\n<meta property=\"og:description\" content=\"Madrigal secures EU approval for REZDIFFRA targeting MASH with liver fibrosis, marking a major step in NASH therapy. Meanwhile, Valneva faces a setback as the FDA suspends its license for the chikungunya vaccine IXCHIQ. In ALS research, Coya achieves FDA IND clearance for COYA 302, advancing potential treatment options. 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Rusfertide gains FDA Breakthrough Therapy designation for polycythemia vera, accelerating its clinical development, while Crinetics earns FDA Orphan Drug status for Atumelnant in congenital adrenal hyperplasia, highlighting progress in rare disease therapeutics.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.delveinsight.com\/blog\/madrigal-wins-eu-approval-for-rezdiffra-in-mash-with-liver-fibrosis-valneva-faces-fda-license-suspension-for-chikungunya-vaccine-ixchiq-coya-secures-fda-ind-clearance-for-coya-302-in-als-treatment","og_locale":"en_US","og_type":"article","og_title":"Madrigal Wins EU Approval for REZDIFFRA in MASH With Liver Fibrosis; Valneva Faces FDA License Suspension for Chikungunya Vaccine IXCHIQ; Coya Secures FDA IND Clearance for COYA 302 in ALS Treatment; Rusfertide Earns FDA Breakthrough Therapy Designation for Polycythemia Vera; Crinetics Gains FDA Orphan Drug Status for Atumelnant in Congenital Adrenal Hyperplasia - DelveInsight Business Research","og_description":"Madrigal secures EU approval for REZDIFFRA targeting MASH with liver fibrosis, marking a major step in NASH therapy. 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