{"id":32984,"date":"2025-07-22T16:45:00","date_gmt":"2025-07-22T11:15:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=32984"},"modified":"2025-08-05T19:05:10","modified_gmt":"2025-08-05T13:35:10","slug":"pharma-news-for-sarepta-imcheck-redhill","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-sarepta-imcheck-redhill","title":{"rendered":"Sarepta Therapeutics Pauses ELEVIDYS Shipments in U.S. After FDA Intervention Over Patient Deaths; ImCheck\u2019s ICT01 Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia; RedHill Biopharma Gets Positive FDA Feedback on RHB-204 for Crohn\u2019s Disease Approval Pathway; FDA Grants Fast Track Designation to ProMIS Neurosciences\u2019 PMN310 for Alzheimer\u2019s Disease; Oruka Therapeutics Receives IND Clearance for Phase IIa Trial of ORKA-001 in Psoriasis"},"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-69e939a92765f\" 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-69e939a92765f\"  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-sarepta-imcheck-redhill\/#Sarepta_Therapeutics_Pauses_ELEVIDYS_Shipments_in_US_After_FDA_Intervention_Over_Patient_Deaths\" >Sarepta Therapeutics Pauses ELEVIDYS Shipments in U.S. After FDA Intervention Over Patient Deaths<\/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-sarepta-imcheck-redhill\/#ImChecks_ICT01_Granted_FDA_Orphan_Drug_Designation_for_Acute_Myeloid_Leukemia\" >ImCheck\u2019s ICT01 Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia<\/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-sarepta-imcheck-redhill\/#RedHill_Biopharma_Gets_Positive_FDA_Feedback_on_RHB-204_for_Crohns_Disease_Approval_Pathway\" >RedHill Biopharma Gets Positive FDA Feedback on RHB-204 for Crohn\u2019s Disease Approval Pathway<\/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-sarepta-imcheck-redhill\/#FDA_Grants_Fast_Track_Designation_to_ProMIS_Neurosciences_PMN310_for_Alzheimers_Disease\" >FDA Grants Fast Track Designation to ProMIS Neurosciences\u2019 PMN310 for Alzheimer\u2019s Disease<\/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-sarepta-imcheck-redhill\/#Oruka_Therapeutics_Receives_IND_Clearance_for_Phase_IIa_Trial_of_ORKA-001_in_Psoriasis\" >Oruka Therapeutics Receives IND Clearance for Phase IIa Trial of ORKA-001 in Psoriasis<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-sarepta-therapeutics-pauses-elevidys-shipments-in-u-s-after-fda-intervention-over-patient-deaths\"><span class=\"ez-toc-section\" id=\"Sarepta_Therapeutics_Pauses_ELEVIDYS_Shipments_in_US_After_FDA_Intervention_Over_Patient_Deaths\"><\/span>Sarepta Therapeutics Pauses ELEVIDYS Shipments in U.S. After FDA Intervention Over Patient Deaths<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Sarepta Therapeutics, Inc. <\/strong>has voluntarily and temporarily paused all shipments of <strong>ELEVIDYS (delandistrogene moxeparvovec)<\/strong> in the U.S., effective July 22, 2025, following engagement with the FDA on safety labeling updates. The decision comes amid the ongoing label supplement process and post-marketing safety discussions after adverse events were reported in patients with <a href=\"https:\/\/www.delveinsight.com\/report-store\/duchenne-muscular-dystrophy-market\"><strong>Duchenne muscular dystrophy (DMD)<\/strong><\/a>.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cAs a patient-centric organization, the decision to voluntarily and temporarily pause shipments of ELEVIDYS was a painful one, as individuals with Duchenne are losing muscle daily and in need of disease-modifying options,\u201d said Doug Ingram, President and CEO of Sarepta. \u201cMaintaining a positive and productive working relationship with the FDA is critical as we work collaboratively to complete the safety review process.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>ELEVIDYS, Sarepta\u2019s single-dose gene therapy, was granted accelerated approval for use in ambulatory and non-ambulatory DMD patients aged four years and older with confirmed mutations in the DMD gene. Continued approval for non-ambulatory patients is contingent on confirmatory trial results demonstrating clinical benefit. The therapy is contraindicated in patients with deletions in exon 8 and\/or exon 9 due to risks of immune-mediated myositis and other severe reactions.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Sarepta confirmed its continued commitment to transparency and patient safety. \u201cThis pause will allow us to respond to the FDA\u2019s requests and complete the necessary label supplement process without compromising trust or safety,\u201d Ingram added. The company intends to provide timely updates to the DMD community as more information becomes available.<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-imcheck-s-ict01-granted-fda-orphan-drug-designation-for-acute-myeloid-leukemia\"><span class=\"ez-toc-section\" id=\"ImChecks_ICT01_Granted_FDA_Orphan_Drug_Designation_for_Acute_Myeloid_Leukemia\"><\/span>ImCheck\u2019s ICT01 Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>ImCheck Therapeutics <\/strong>announced that the FDA has granted <strong>Orphan Drug Designation (ODD)<\/strong> to its lead candidate, <strong>ICT01<\/strong>, for the treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/acute-myeloid-leukemia-aml-market\"><strong>acute myeloid leukemia (AML)<\/strong><\/a>. The designation follows compelling results from the Phase I\/II EVICTION study presented at the 2025 ASCO Annual Meeting.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cReceiving FDA orphan drug designation for ICT01 is a significant recognition of ICT01\u2019s innovative therapeutic potential to meet the urgent unmet medical needs of AML patients,\u201d said Dr. Stephan Braun, Chief Medical Officer at ImCheck Therapeutics. \u201cThis milestone reinforces our confidence that ICT01 will become the first immunotherapy for AML patients.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>ICT01, a humanized anti-BTN3A monoclonal antibody, selectively activates \u03b39\u03b42 T cells and is being evaluated in combination with azacitidine and venetoclax in newly diagnosed AML patients who are unfit for intensive chemotherapy. The treatment showed unprecedented remission rates and a positive overall survival signal across genetically diverse subgroups, with a safety profile consistent with standard hematological toxicities.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cOrphan drug designation is a catalyst,\u201d added Pierre d\u2019Epenoux, CEO of ImCheck. \u201cIt validates our regulatory strategy, de-risks development, and accelerates our efforts to position ICT01 as a transformative therapy in AML and potentially other solid tumors.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-redhill-biopharma-gets-positive-fda-feedback-on-rhb-204-for-crohn-s-disease-approval-pathway\"><span class=\"ez-toc-section\" id=\"RedHill_Biopharma_Gets_Positive_FDA_Feedback_on_RHB-204_for_Crohns_Disease_Approval_Pathway\"><\/span>RedHill Biopharma Gets Positive FDA Feedback on RHB-204 for Crohn\u2019s Disease Approval Pathway<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>RedHill Biopharma <\/strong>announced today that the FDA has provided constructive guidance for advancing its lead candidate, <strong>RHB-204,<\/strong> into a novel phase II study for <a href=\"https:\/\/www.delveinsight.com\/report-store\/crohns-disease-cd-market\"><strong>Crohn\u2019s disease (CD)<\/strong><\/a><strong>.<\/strong> The trial is expected to be the first to enroll only Mycobacterium avium subspecies paratuberculosis (MAP)-positive CD patients\u2014potentially validating MAP as a root cause of the disease and positioning RHB-204 as a paradigm-shifting therapy targeting both etiology and symptoms.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis FDA feedback supports a pioneering approach to Crohn\u2019s disease, and we\u2019re excited to lead the first study specifically designed to assess treatment efficacy in MAP-positive patients,\u201d said Dr. Reza Fathi, RedHill\u2019s Senior VP of R&amp;D. \u201cWe believe RHB-204 could offer a safer, more effective oral alternative to current therapies, especially for patients unresponsive to biologics.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The phase II trial will utilize cutting-edge MAP detection diagnostics, addressing a key historical barrier in MAP-related research. RedHill has established collaborations with two academic institutions to implement these rapid tests. The trial will focus on mucosal and clinical remission as primary endpoints, in alignment with FDA guidance and supported by data from the earlier phase III RHB-104 study, which showed a 64% improvement in efficacy over standard of care.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cRHB-204 builds on the success of RHB-104 and represents a major step forward in treating CD with a novel, oral immunomodulatory strategy,\u201d said Guy Goldberg, CEO of RedHill. \u201cWith strong IP protection through 2041 and non-dilutive funding pathways under discussion, we\u2019re well-positioned to deliver a transformational therapy in a market projected to exceed $19 billion by 2033.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-grants-fast-track-designation-to-promis-neurosciences-pmn310-for-alzheimer-s-disease\"><span class=\"ez-toc-section\" id=\"FDA_Grants_Fast_Track_Designation_to_ProMIS_Neurosciences_PMN310_for_Alzheimers_Disease\"><\/span>FDA Grants Fast Track Designation to ProMIS Neurosciences\u2019 PMN310 for Alzheimer\u2019s Disease<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>ProMIS Neurosciences<\/strong> announced that the <strong>FDA<\/strong> has granted <strong>Fast Track designation<\/strong> to its lead antibody therapy, <strong>PMN310<\/strong>, currently being developed for <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/alzheimers-disease-ad-market\" class=\"ek-link\">Alzheimer\u2019s disease (AD)<\/a>.<\/strong> The designation is intended to expedite the development of drugs that target serious conditions with unmet medical needs and will allow ProMIS to benefit from enhanced regulatory guidance and a streamlined path toward potential approval.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis is a pivotal moment for ProMIS and the Alzheimer\u2019s community,\u201d said Neil Warma, President and CEO of ProMIS Neurosciences. \u201cReceiving Fast Track designation not only underscores the potential of PMN310 to address a critical unmet need but also provides valuable opportunities for regulatory insight as we advance toward key clinical milestones.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>PMN310 is designed to selectively target toxic misfolded forms of amyloid-beta, which are believed to drive AD pathology while sparing normal forms that may play protective roles. This mechanism may reduce the incidence of amyloid-related imaging abnormalities (ARIA)\u2014serious side effects such as brain swelling and bleeding observed with other AD therapies\u2014while delivering stronger efficacy.<\/p>\n\n\n\n<p>The ongoing PRECISE-AD phase Ib trial is assessing PMN310 in early-stage Alzheimer\u2019s patients, focusing on safety, tolerability, pharmacokinetics, and disease-relevant biomarkers. Interim six-month biomarker and safety data are expected in Q2 2026, with final results anticipated in Q4 2026.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-oruka-therapeutics-receives-ind-clearance-for-phase-iia-trial-of-orka-001-in-psoriasis\"><span class=\"ez-toc-section\" id=\"Oruka_Therapeutics_Receives_IND_Clearance_for_Phase_IIa_Trial_of_ORKA-001_in_Psoriasis\"><\/span>Oruka Therapeutics Receives IND Clearance for Phase IIa Trial of ORKA-001 in Psoriasis<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Oruka Therapeutics <\/strong>has received <strong>FDA <\/strong>clearance to initiate <strong>EVERLAST-A<\/strong>, a randomized, double-blind, placebo-controlled Phase IIa trial evaluating ORKA-001, a long-acting anti-IL-23p19 antibody, in <a href=\"https:\/\/www.delveinsight.com\/report-store\/moderate-to-severe-psoriasis-market\"><strong>moderate-to-severe psoriasis<\/strong><\/a>. The trial will enroll approximately 80 patients, randomized 3:1 to receive ORKA-001 or placebo, with the primary endpoint being PASI 100 at Week 16. Initial efficacy and response duration data are expected in the second half of 2026.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWe\u2019re thrilled by this rapid progress into Phase II development, and very excited to start our first psoriasis study,\u201d said Lawrence Klein, PhD, CEO of Oruka. \u201cWe think that ORKA-001 can redefine the standard of care in this important disease with potential for once-per-year dosing, off-treatment remissions, and higher rates of disease clearance.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>EVERLAST-A also includes an extended dosing component: patients who achieve PASI 100 by Week 28 will be randomized 2:1 into a no-dose arm or biannual dosing arm to evaluate the durability of remission. Additional design details and interim Phase I data will be presented at the upcoming EADV Congress in September.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Dr. Bruce Strober, lead Principal Investigator of the EVERLAST-A study, commented, \u201cI\u2019m excited about EVERLAST-A and the potential that ORKA-001 could enable long dosing intervals and greater efficacy than current IL-23 inhibiting medications. These improvements could be a significant step forward for both patients and the field.\u201d<\/em><\/p>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>Sarepta Therapeutics Pauses ELEVIDYS Shipments in U.S. After FDA Intervention Over Patient Deaths Sarepta Therapeutics, Inc. has voluntarily and temporarily paused all shipments of ELEVIDYS (delandistrogene moxeparvovec) in the U.S., effective July 22, 2025, following engagement with the FDA on safety labeling updates. The decision comes amid the ongoing label supplement process and post-marketing safety [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":32985,"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":[18089,59,22440,22442,22441,72,13263,22447,20372,2077,204,1796,218,19107,12862,17916,704,349,420,639,5587,5586,20561],"industry":[17225],"therapeutic_areas":[17239,17238,17227,17245,17228],"class_list":["post-32984","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-acute-myeloid-leukemia","tag-acute-myeloid-leukemia-aml","tag-acute-myeloid-leukemia-drugs","tag-acute-myeloid-leukemia-market","tag-acute-myeloid-leukemia-treatment","tag-alzheimers-disease","tag-alzheimers-disease-market-2","tag-alzheimers-disease-pipeline-2","tag-alzheimers-disease-treatment","tag-crohns-disease","tag-delveinsight","tag-duchenne-muscular-dystrophy","tag-duchenne-muscular-dystrophy-dmd","tag-duchenne-muscular-dystrophy-epidemiology","tag-duchenne-muscular-dystrophy-pipeline","tag-duchenne-muscular-dystrophy-treatment","tag-fda","tag-latest-pharma-news","tag-news","tag-pharma-news","tag-psoriasis","tag-psoriasis-market","tag-psoriasis-treatment","industry-pharmaceutical","therapeutic_areas-gastroenterology","therapeutic_areas-genetic-disorders","therapeutic_areas-immunological-and-autoimmune-disorders","therapeutic_areas-neurology","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- 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