{"id":32406,"date":"2025-06-10T16:40:37","date_gmt":"2025-06-10T11:10:37","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=32406"},"modified":"2025-06-10T17:13:40","modified_gmt":"2025-06-10T11:43:40","slug":"pharma-news-for-amylyx-cellectar-merck","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-amylyx-cellectar-merck","title":{"rendered":"Amylyx\u2019s AMX0114 Fast Tracked by FDA for ALS; Cellectar\u2019s Iopofosine I 131 Granted FDA Breakthrough in Waldenstrom Macroglobulinemia; YolTech\u2019s YOLT-101 Clears FDA IND for Familial Hypercholesterolemia; Oncovita\u2019s MVdeltaC Gets FDA Orphan Tag for Pleural Mesothelioma; Merck\u2019s ENFLONSIA Approved for RSV Prevention in Infants"},"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-69efbf40367d1\" 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-69efbf40367d1\"  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-amylyx-cellectar-merck\/#Amylyx_Pharmaceuticals_Receives_FDA_Fast_Track_Designation_for_AMX0114_in_ALS\" >Amylyx Pharmaceuticals Receives FDA Fast Track Designation for AMX0114 in ALS<\/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-amylyx-cellectar-merck\/#Cellectar_Secures_FDA_Breakthrough_Therapy_Designation_for_Iopofosine_I_131_in_Waldenstrom_Macroglobulinemia\" >Cellectar Secures FDA Breakthrough Therapy Designation for Iopofosine I 131 in Waldenstrom Macroglobulinemia<\/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-amylyx-cellectar-merck\/#YolTech_Therapeutics_Receives_FDA_IND_Clearance_for_YOLT-101_in_Familial_Hypercholesterolemia\" >YolTech Therapeutics Receives FDA IND Clearance for YOLT-101 in Familial Hypercholesterolemia<\/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-amylyx-cellectar-merck\/#Oncovita_Awarded_FDA_Orphan_Drug_Designation_for_MVdeltaC_in_Pleural_Mesothelioma\" >Oncovita Awarded FDA Orphan Drug Designation for MVdeltaC in Pleural Mesothelioma<\/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-amylyx-cellectar-merck\/#FDA_Approves_Mercks_ENFLONSIA_for_Prevention_of_RSV_in_Infants\" >FDA Approves Merck\u2019s ENFLONSIA&nbsp; for Prevention of RSV in Infants<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-amylyx-pharmaceuticals-receives-fda-fast-track-designation-for-amx0114-in-als\"><span class=\"ez-toc-section\" id=\"Amylyx_Pharmaceuticals_Receives_FDA_Fast_Track_Designation_for_AMX0114_in_ALS\"><\/span>Amylyx Pharmaceuticals Receives FDA Fast Track Designation for AMX0114 in ALS<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Amylyx Pharmaceuticals<\/strong> announced that the <strong>FDA has granted Fast Track designation<\/strong> to its investigational <a href=\"https:\/\/www.delveinsight.com\/report-store\/antisense-oligonucleotide-therapeutics-pipeline-insight\">antisense oligonucleotide (ASO)<\/a>, <strong>AMX0114<\/strong>, for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/amyotrophic-lateral-sclerosis-als-market\">treatment of <strong>amyotrophic lateral sclerosis (ALS)<\/strong><\/a>. The candidate targets calpain-2, an enzyme linked to axonal degeneration, a critical driver of ALS progression.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cObtaining FDA Fast Track designation for AMX0114 is an important step forward in our mission to develop potential treatments for people living with ALS, a relentlessly progressive and fatal disease with limited therapeutic options,\u201d said Dr. Camille L. Bedrosian, Chief Medical Officer, Amylyx. \u201cThe FDA\u2019s recognition underscores both the seriousness of ALS and the promising preclinical evidence supporting AMX0114\u2019s potential to target calpain-2.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The Fast Track designation facilitates closer interaction with the FDA, eligibility for Priority Review, and a potentially faster development pathway. AMX0114 showed improved neuronal survival and reduced extracellular neurofilament light (NfL) levels in preclinical studies across multiple models of neurodegeneration.<\/p>\n\n\n\n<p>Amylyx began dosing patients in <strong>April 2025<\/strong> in the Phase I LUMINA trial, a multinational, randomized, placebo-controlled study evaluating AMX0114\u2019s safety and biological activity in ALS patients. Approximately 48 participants are being enrolled, with early cohort data expected later this year.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-cellectar-secures-fda-breakthrough-therapy-designation-for-iopofosine-i-131-in-waldenstrom-macroglobulinemia\"><span class=\"ez-toc-section\" id=\"Cellectar_Secures_FDA_Breakthrough_Therapy_Designation_for_Iopofosine_I_131_in_Waldenstrom_Macroglobulinemia\"><\/span>Cellectar Secures FDA Breakthrough Therapy Designation for Iopofosine I 131 in Waldenstrom Macroglobulinemia<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The FDA has awarded <strong>Breakthrough Therapy Designation<\/strong> to <strong>Cellectar Biosciences<\/strong>&#8216; investigational drug, <strong>iopofosine I 131, <\/strong>for the treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/waldenstrom-macroglobulinemia-market\"><strong>relapsed\/refractory Waldenstrom macroglobulinemia (r\/r WM)<\/strong><\/a>. The agent, a novel phospholipid ether radioconjugate, is positioned as a potential first-in-class monotherapy targeting this life-threatening hematologic malignancy.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe FDA\u2019s Breakthrough Therapy Designation underscores the potential of iopofosine I 131, as it may offer substantial improvement on at least one clinically significant endpoint over available therapies,\u201d said James Caruso, President and CEO, Cellectar. \u201cWith robust clinical data, expedited review designations, and compelling commercial potential, we believe iopofosine I 131 is an attractive candidate for collaboration and accelerated development.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The designation is supported by data from the Phase II CLOVER WaM study (NCT02952508), where iopofosine I 131 demonstrated an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2%, far exceeding the trial\u2019s primary endpoint. Results were presented at the 66th ASH Annual Meeting in December 2024 by Dr. Sikander Ailawadhi of Mayo Clinic.<\/p>\n\n\n\n<p>In addition to Breakthrough status, iopofosine I 131 has already secured FDA Fast Track and Orphan Drug Designations and EMA PRIME and Orphan Designations. Cellectar recently submitted a data package to the EMA and expects a decision by late July 2025 on whether to proceed with a Conditional Marketing Authorization Application (MAA) for the European market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-yoltech-therapeutics-receives-fda-ind-clearance-for-yolt-101-in-familial-hypercholesterolemia\"><span class=\"ez-toc-section\" id=\"YolTech_Therapeutics_Receives_FDA_IND_Clearance_for_YOLT-101_in_Familial_Hypercholesterolemia\"><\/span>YolTech Therapeutics Receives FDA IND Clearance for YOLT-101 in Familial Hypercholesterolemia<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The FDA has approved <strong>YolTech Therapeutics&#8217; <\/strong>Investigational New Drug (IND) application for <strong>YOLT-101, <\/strong>an in vivo base editing therapy designed to target <a href=\"https:\/\/www.delveinsight.com\/report-store\/pcsk9-inhibitors-psck9i-market\"><strong>PCSK9<\/strong><\/a> for the treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/heterozygous-familial-hypercholesterolemia-hefh-market\"><strong>heterozygous familial hypercholesterolemia (HeFH)<\/strong><\/a>, a rare genetic disorder leading to dangerously high cholesterol levels.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe FDA IND clearance marks a significant milestone for YolTech,\u201d said Dr. Yuxuan Wu, Co-founder and CEO of YolTech. \u201cIn vivo gene editing represents a new generation of therapeutics, offering one-time, durable solutions for chronic and genetic diseases. We are committed to advancing breakthrough gene editing solutions that offer transformative benefits for patients with severe genetic and cardiovascular diseases.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>YOLT-101 utilizes base editing to permanently modify the PCSK9 gene in vivo, aiming to deliver a long-lasting reduction in LDL cholesterol after a single administration. If successful, this approach could eliminate the need for chronic lipid-lowering treatments in HeFH patients.<\/p>\n\n\n\n<p>With the IND now cleared, YolTech will proceed with its first-in-human clinical trial of YOLT-101 in HeFH patients, advancing a promising new gene editing approach for cardiovascular disease management.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-oncovita-awarded-fda-orphan-drug-designation-for-mvdeltac-in-pleural-mesothelioma\"><span class=\"ez-toc-section\" id=\"Oncovita_Awarded_FDA_Orphan_Drug_Designation_for_MVdeltaC_in_Pleural_Mesothelioma\"><\/span>Oncovita Awarded FDA Orphan Drug Designation for MVdeltaC in Pleural Mesothelioma<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Oncovita<\/strong> announced that the<strong> FDA<\/strong> has granted <strong>Orphan Drug Designation (ODD)<\/strong> to its lead investigational therapy, <strong>MVdeltaC<\/strong>, for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/malignant-pleural-mesothelioma-market\">treatment of <strong>pleural mesothelioma<\/strong><\/a>, a rare, aggressive cancer with significant unmet medical need and limited therapeutic options.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cReceiving Orphan Drug Designation for MVdeltaC marks a major milestone for Oncovita and validates our approach of harnessing measles vaccine viruses to treat solid tumors,\u201d said St\u00e9phane Altaba, CEO of Oncovita. \u201cThis regulatory support strengthens our strategy to advance innovative immunotherapies as we prepare to enter clinical development with MVdeltaC by 2026.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>MVdeltaC is a novel <strong>oncolytic immunotherapy<\/strong> based on a genetically modified attenuated <strong>Schwarz strain measles virus<\/strong>, designed to selectively replicate in tumor cells, induce direct tumor lysis, and trigger a systemic anti-cancer immune response. The platform holds promise for improving outcomes in pleural mesothelioma and other difficult-to-treat solid tumors.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWith this designation, Oncovita is now well-positioned to advance MVdeltaC in the U.S. market,\u201d added Dr. St\u00e9phane Champiat, Head of Medical Affairs. The FDA\u2019s ODD provides incentives such as tax credits, fee waivers, and up to seven years of market exclusivity upon approval, accelerating the path to market for therapies targeting rare diseases.<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-approves-merck-s-enflonsia-nbsp-for-prevention-of-rsv-in-infants\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Mercks_ENFLONSIA_for_Prevention_of_RSV_in_Infants\"><\/span>FDA Approves Merck\u2019s ENFLONSIA&nbsp; for Prevention of RSV in Infants<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The FDA has granted approval to <strong>Merck&#8217;s ENFLONSIA (clesrovimab-cfor) <\/strong>for preventing <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/respiratory-syncytial-virus-rsv-market\" class=\"ek-link\">respiratory syncytial virus (RSV)<\/a><\/strong> lower respiratory tract disease in <strong>newborns and infants<\/strong> entering their first RSV season. ENFLONSIA is a <strong>long-acting monoclonal antibody<\/strong> designed to provide durable protection through a typical 5-month RSV season with a single <strong>105 mg dose<\/strong> regardless of weight.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cRSV disease is the leading cause of infant hospitalization in the U.S. and can lead to serious conditions like bronchiolitis and pneumonia,\u201d said Dr. Octavio Ramilo of St. Jude Children\u2019s Research Hospital and lead investigator for the CLEVER and SMART trials. \u201cENFLONSIA combines dosing convenience with strong clinical data showing significant reductions in RSV disease incidence and hospitalizations.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>FDA approval is based on results from the pivotal <strong>Phase IIb\/III CLEVER<\/strong> trial, where ENFLONSIA reduced RSV-associated medically attended lower respiratory infections by <strong>60.5%<\/strong> and hospitalizations by <strong>84.3%<\/strong> compared to placebo. Additional supportive data came from the <strong>SMART<\/strong> trial, which evaluated ENFLONSIA versus <strong>palivizumab<\/strong> in high-risk infants.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cENFLONSIA provides an important new preventive option with the same dose for all infants, helping reduce the burden of RSV on families and healthcare systems,\u201d added Dr. Dean Y. Li, President of Merck Research Laboratories. CDC\u2019s Advisory Committee on Immunization Practices will review use recommendations later this month, with U.S. availability targeted before the 2025\u20132026 RSV season.<\/em><\/p>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>Amylyx Pharmaceuticals Receives FDA Fast Track Designation for AMX0114 in ALS Amylyx Pharmaceuticals announced that the FDA has granted Fast Track designation to its investigational antisense oligonucleotide (ASO), AMX0114, for the treatment of amyotrophic lateral sclerosis (ALS). The candidate targets calpain-2, an enzyme linked to axonal degeneration, a critical driver of ALS progression. \u201cObtaining FDA [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":32407,"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":[74,19150,19151,16807,2025,204,19811,704,18083,349,4247,420,19808,639,5789,17615,2009,20654,20608,20285,4864],"industry":[17225],"therapeutic_areas":[17240,17231,17245,17228],"class_list":["post-32406","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-market","tag-antisense-oligonucleotides-asos","tag-delveinsight","tag-familial-hypercholesterolemia","tag-fda","tag-heterozygous-familial-hypercholesterolemia","tag-latest-pharma-news","tag-malignant-pleural-mesothelioma","tag-news","tag-pcsk9-inhibitors","tag-pharma-news","tag-recent-pharma-news","tag-respiratory-syncytial-virus","tag-respiratory-syncytial-virus-rsv","tag-respiratory-syncytial-virus-market","tag-respiratory-syncytial-virus-treatment","tag-waldenstrom-macroglobulinemia","tag-waldenstroms-macroglobulinemia","industry-pharmaceutical","therapeutic_areas-endocrinology-and-metabolic-disorders","therapeutic_areas-infectious-diseases","therapeutic_areas-neurology","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 | Amylyx, Cellectar, Merck<\/title>\n<meta name=\"description\" content=\"Amylyx\u2019s AMX0114; Cellectar\u2019s Iopofosine I 131; YolTech\u2019s YOLT-101; Oncovita\u2019s MVdeltaC; Merck\u2019s ENFLONSIA\" \/>\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-amylyx-cellectar-merck\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Amylyx, Cellectar, Merck\" \/>\n<meta property=\"og:description\" content=\"Amylyx\u2019s AMX0114; Cellectar\u2019s Iopofosine I 131; YolTech\u2019s YOLT-101; Oncovita\u2019s MVdeltaC; Merck\u2019s ENFLONSIA\" \/>\n<meta property=\"og:url\" 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