{"id":30183,"date":"2024-10-29T16:45:17","date_gmt":"2024-10-29T11:15:17","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=30183"},"modified":"2024-10-29T16:45:20","modified_gmt":"2024-10-29T11:15:20","slug":"pharma-news-for-modalis-pfizer-hibercell","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-modalis-pfizer-hibercell","title":{"rendered":"FDA Grants Orphan Status to MDL-101 for LAMA2-CMD; Pfizer\u2019s ABRYSVO Approved for High-Risk Adults (18-59); KIND\u2019s AND017 Gains Orphan Designation for Sickle Cell Disease; HiberCell\u2019s HC-7366 Fast-Tracked for AML; ORLYNVAH Approved for Uncomplicated UTIs"},"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-69f4333189c49\" 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-69f4333189c49\"  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-modalis-pfizer-hibercell\/#FDA_Grants_Orphan_Drug_Status_to_MDL-101_for_LAMA2-CMD_Treatment\" >FDA Grants Orphan Drug Status to MDL-101 for LAMA2-CMD Treatment<\/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-modalis-pfizer-hibercell\/#Pfizers_RSV_Vaccine_ABRYSVO_Gains_FDA_Approval_for_High-Risk_Adults_Aged_18-59\" >Pfizer\u2019s RSV Vaccine, ABRYSVO, Gains FDA Approval for High-Risk Adults Aged 18-59<\/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-modalis-pfizer-hibercell\/#KINDs_AND017_Secures_FDA_Orphan_Drug_Designation_for_Sickle_Cell_Disease\" >KIND\u2019s AND017 Secures FDA Orphan Drug Designation for Sickle Cell Disease<\/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-modalis-pfizer-hibercell\/#FDA_Fast-Tracks_HiberCells_HC-7366_for_RelapsedRefractory_AML_Treatment\" >FDA Fast-Tracks HiberCell\u2019s HC-7366 for Relapsed\/Refractory AML Treatment<\/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-modalis-pfizer-hibercell\/#FDA_Approves_Iterums_ORLYNVAH_for_Treating_Uncomplicated_UTIs\" >FDA Approves Iterum\u2019s ORLYNVAH for Treating Uncomplicated UTIs<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-grants-orphan-drug-status-to-mdl-101-for-lama2-cmd-treatment\"><span class=\"ez-toc-section\" id=\"FDA_Grants_Orphan_Drug_Status_to_MDL-101_for_LAMA2-CMD_Treatment\"><\/span>FDA Grants Orphan Drug Status to MDL-101 for LAMA2-CMD Treatment<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Modalis Therapeutics Corporation has received Orphan Drug Designation (ODD) from the FDA for <strong>MDL-101<\/strong>, its promising <a href=\"https:\/\/www.delveinsight.com\/report-store\/duchenne-muscular-dystrophy-market\">treatment for <strong>congenital muscular dystrophy type 1A (LAMA2-CMD)<\/strong><\/a>. This designation is a significant step, aimed at fostering the development of essential therapies for rare diseases affecting fewer than 200,000 individuals in the U.S. It supports Modalis\u2019 commitment to addressing urgent, underserved medical needs.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Haru Morita, CEO of Modalis Therapeutics, expressed optimism about the development: \u201cReceiving Orphan Drug Designation from the FDA is not only a validation of the pressing medical need we\u2019re addressing but also of our commitment to innovative solutions for rare diseases. MDL-101 has the potential to make a life-changing impact for those living with LAMA2-CMD.\u201d This ODD status enables Modalis to access various incentives, including application fee exemptions and federal tax benefits, which are instrumental in advancing MDL-101 to pivotal clinical trials.<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>LAMA2-CMD is a severe, early-onset form of congenital muscular dystrophy caused by a lack of the LAMA2 protein, which traditional gene therapies have struggled to address due to the protein\u2019s large size. MDL-101, developed using <strong>Modalis\u2019 CRISPR-GNDM\u00ae technology<\/strong>, is designed to overcome this hurdle by modulating the expression of the LAMA1 gene to compensate for LAMA2 deficiencies. The treatment is poised to be the first gene therapy for LAMA2-CMD that targets the disease\u2019s underlying cause.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cOur mission, \u2018Every life deserves attention,\u2019 drives us to innovate for patients who currently have no treatment options,\u201d added Morita. \u201cWith this ODD recognition, we\u2019re a step closer to bringing our CRISPR-based therapy to the individuals and families impacted by this devastating condition.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-pfizer-s-rsv-vaccine-abrysvo-gains-fda-approval-for-high-risk-adults-aged-18-59\"><span class=\"ez-toc-section\" id=\"Pfizers_RSV_Vaccine_ABRYSVO_Gains_FDA_Approval_for_High-Risk_Adults_Aged_18-59\"><\/span>Pfizer\u2019s RSV Vaccine, ABRYSVO, Gains FDA Approval for High-Risk Adults Aged 18-59<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Pfizer Inc. has received <a href=\"https:\/\/www.delveinsight.com\/blog\/abrysvo-for-rsv\">FDA approval for <strong>ABRYSVO<\/strong> (RSVpreF)<\/a>, the first bivalent RSV vaccine now indicated for adults aged 18-59 at increased risk of <a href=\"https:\/\/www.delveinsight.com\/report-store\/respiratory-syncytial-virus-rsv-market\">RSV-related lower respiratory tract disease<\/a>. Previously approved for adults over 60 and pregnant individuals in their third trimester, ABRYSVO now has the broadest RSV indication among vaccines for adults, addressing critical protection needs for younger adults with chronic health conditions.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cRSV presents a serious risk for adults with certain chronic conditions,\u201d stated Aamir Malik, Pfizer\u2019s Chief U.S. Commercial Officer and Executive VP. \u201cThis approval allows us to better support the high-risk adult population, making ABRYSVO the only RSV vaccine available to adults 18-49 with underlying conditions.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The FDA\u2019s decision is supported by the Phase III <strong>MONeT trial<\/strong> (NCT05842967), which demonstrated ABRYSVO\u2019s safety and immunogenicity in adults with chronic diseases like COPD, diabetes, and heart failure, who are at greater risk of RSV-associated complications. Pfizer plans to publish and present the results at upcoming scientific forums.<\/p>\n\n\n\n<p>With approximately 9.5% of U.S. adults aged 18-49 living with conditions that heighten RSV risk, the expanded indication is poised to provide vital protection to a vulnerable population.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-kind-s-and017-secures-fda-orphan-drug-designation-for-sickle-cell-disease\"><span class=\"ez-toc-section\" id=\"KINDs_AND017_Secures_FDA_Orphan_Drug_Designation_for_Sickle_Cell_Disease\"><\/span>KIND\u2019s AND017 Secures FDA Orphan Drug Designation for Sickle Cell Disease<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Kind Pharmaceutical has announced that its investigational drug <strong>AND017<\/strong> has received <strong>Orphan Drug Designation (ODD)<\/strong> from the FDA for <a href=\"https:\/\/www.delveinsight.com\/report-store\/sickle-cell-disease-6mm-market\">the treatment of <strong>Sickle Cell Disease<\/strong><\/a>. This milestone highlights AND017&#8217;s potential to provide a novel, effective oral therapy for SCD, a genetic disorder affecting around 120,000 people in the U.S., primarily Black and African American populations.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;The FDA\u2019s ODD for AND017 underscores the urgent need for innovative therapies in SCD,&#8221; said <\/em><strong><em>Dr. Dong Liu<\/em><\/strong><em>, Founder and CEO of Kind Pharmaceutical. &#8220;This designation not only validates our mission to address underserved conditions but also highlights our capabilities in pioneering treatments that could transform lives.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>AND017 is currently in <strong>Phase II trials<\/strong> for anemia associated with both non-dialysis-dependent and dialysis-dependent chronic kidney disease (CKD). Results were presented at the <strong>American Society of Nephrology\u2019s Kidney Week<\/strong>. Meanwhile, SCD-focused preclinical studies supporting the ODD will be published soon.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWith only limited oral treatments available for SCD, AND017 stands out for its unique mechanism and promising safety profile,\u201d said <\/em><strong><em>Professor Gang Huang<\/em><\/strong><em> from UT Health San Antonio, who contributed to AND017\u2019s preclinical studies. &#8220;The compelling preclinical data on AND017 suggests significant potential, and I am eager to see how it performs in patients.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-fast-tracks-hibercell-s-hc-7366-for-relapsed-refractory-aml-treatment\"><span class=\"ez-toc-section\" id=\"FDA_Fast-Tracks_HiberCells_HC-7366_for_RelapsedRefractory_AML_Treatment\"><\/span>FDA Fast-Tracks HiberCell\u2019s HC-7366 for Relapsed\/Refractory AML Treatment<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>HiberCell, Inc. has announced that the FDA has granted <strong>Fast Track designation<\/strong> to <strong>HC-7366<\/strong> for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/acute-myeloid-leukemia-aml-market\">treatment of adult patients with relapsed or refractory <strong>acute myeloid leukemia<\/strong><\/a>. This designation will help accelerate the development and review of HC-7366, a novel therapeutic targeting the GCN2 pathway, to address the unmet needs of AML patients.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWe are honored by the FDA\u2019s grant of Fast Track designation for HC-7366,\u201d stated <\/em><strong><em>Jonathan Lanfear<\/em><\/strong><em>, President &amp; CEO of HiberCell. \u201cThis recognition emphasizes the promise of HC-7366 and highlights the significant need for new treatments in relapsed and refractory AML.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>HC-7366, the first <strong>GCN2-activator<\/strong> in clinical testing for AML, is currently in a <strong>Phase Ib trial<\/strong> to evaluate its safety and preliminary efficacy in relapsed\/refractory AML patients. The study will also establish the recommended Phase II dose (RP2D), with potential for combination and monotherapy expansions based on initial findings.<\/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, we are eager to collaborate closely with the FDA to expedite HC-7366\u2019s development and potentially bring a new therapeutic option to AML patients sooner,\u201d Lanfear added.<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-approves-iterum-s-orlynvah-for-treating-uncomplicated-utis\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Iterums_ORLYNVAH_for_Treating_Uncomplicated_UTIs\"><\/span>FDA Approves Iterum\u2019s ORLYNVAH for Treating Uncomplicated UTIs<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Iterum Therapeutics has received FDA approval for <strong>ORLYNVAH<\/strong> (sulopenem etzadroxil and probenecid), a new oral <a href=\"https:\/\/www.delveinsight.com\/report-store\/uncomplicated-urinary-tract-infection-uuti-market\">treatment for uncomplicated urinary tract infections<\/a> in adult women with limited alternative options. This approval marks the first FDA-approved product for Iterum and introduces the first oral penem in the U.S. market.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;We are thrilled to bring ORLYNVAH\u2122 to patients facing difficult-to-treat uUTIs,&#8221; stated <\/em><strong><em>Corey Fishman<\/em><\/strong><em>, CEO of Iterum. &#8220;This milestone highlights our commitment to addressing antimicrobial resistance and providing an effective alternative for underserved patients.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The approval is supported by two Phase III trials, <strong>SURE 1<\/strong> and <strong>REASSURE<\/strong>, which demonstrated ORLYNVAH\u2019s safety and efficacy. In SURE 1, ORLYNVAH outperformed ciprofloxacin in fluoroquinolone-resistant infections, while in REASSURE, it showed non-inferiority and statistical superiority to Augmentin\u2122 for susceptible infections, with both studies indicating ORLYNVAH\u2122 was generally well tolerated.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis approval offers a much-needed option for at-risk patients struggling with UTIs,\u201d commented <\/em><strong><em>Dr. Marjorie Golden<\/em><\/strong><em> of Yale New Haven Hospital. &#8220;ORLYNVAH could be a vital alternative for use in the community based on its impressive clinical profile.&#8221;<\/em><\/p>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>FDA Grants Orphan Drug Status to MDL-101 for LAMA2-CMD Treatment Modalis Therapeutics Corporation has received Orphan Drug Designation (ODD) from the FDA for MDL-101, its promising treatment for congenital muscular dystrophy type 1A (LAMA2-CMD). This designation is a significant step, aimed at fostering the development of essential therapies for rare diseases affecting fewer than 200,000 [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":30185,"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":[18089,204,1797,1796,704,349,420,639,5789,2010,536,19907],"industry":[17225],"therapeutic_areas":[17233,17231,17245,17228,17433,17243],"class_list":["post-30183","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-acute-myeloid-leukemia","tag-delveinsight","tag-dmd","tag-duchenne-muscular-dystrophy","tag-fda","tag-latest-pharma-news","tag-news","tag-pharma-news","tag-recent-pharma-news","tag-rsv","tag-sickle-cell-disease","tag-uncomplicated-urinary-tract-infection","industry-pharmaceutical","therapeutic_areas-hematological-disorders","therapeutic_areas-infectious-diseases","therapeutic_areas-neurology","therapeutic_areas-oncology","therapeutic_areas-pediatrics","therapeutic_areas-respiratory-diseases"],"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 | Modalis, Pfizer, HiberCell<\/title>\n<meta name=\"description\" content=\"MDL-101 Orphan Status, Pfizer\u2019s ABRYSVO, AND017 Orphan Designation, HC-7366 Fast-Tracked, Iterum\u2019s ORLYNVAH Approved\" \/>\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-modalis-pfizer-hibercell\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Modalis, Pfizer, HiberCell\" \/>\n<meta property=\"og:description\" content=\"MDL-101 Orphan Status, Pfizer\u2019s ABRYSVO, AND017 Orphan Designation, HC-7366 Fast-Tracked, Iterum\u2019s ORLYNVAH Approved\" \/>\n<meta property=\"og:url\" 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