{"id":32918,"date":"2025-07-29T17:00:00","date_gmt":"2025-07-29T11:30:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=32918"},"modified":"2025-07-30T09:47:48","modified_gmt":"2025-07-30T04:17:48","slug":"pharma-news-for-ascendis-apellis-entera","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-ascendis-apellis-entera","title":{"rendered":"Ascendis Pharma\u2019s SKYTROFA Approved by FDA for Adult Growth Hormone Deficiency; Apellis Wins FDA Approval for EMPAVELI in C3G and IC-MPGN Treatment; FDA Approves PTC Therapeutics\u2019 Sephience for Phenylketonuria; MAIA Biotechnology\u2019s Ateganosine Gets FDA Fast Track for Non-Small Cell Lung Cancer; Entera Bio Gets FDA Nod on BMD as Primary Endpoint for Phase III Osteoporosis Study"},"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-69f18b4442bb6\" 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-69f18b4442bb6\"  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-ascendis-apellis-entera\/#Ascendis_Pharmas_SKYTROFA_Approved_by_FDA_for_Adult_Growth_Hormone_Deficiency\" >Ascendis Pharma\u2019s SKYTROFA Approved by FDA for Adult Growth Hormone Deficiency<\/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-ascendis-apellis-entera\/#Apellis_Wins_FDA_Approval_for_EMPAVELI_in_C3G_and_IC-MPGN_Treatment\" >Apellis Wins FDA Approval for EMPAVELI in C3G and IC-MPGN 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-ascendis-apellis-entera\/#FDA_Approves_PTC_Therapeutics_Sephience_for_Phenylketonuria_PKU\" >FDA Approves PTC Therapeutics\u2019 Sephience for Phenylketonuria (PKU)<\/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-ascendis-apellis-entera\/#MAIA_Biotechnologys_Ateganosine_Gets_FDA_Fast_Track_for_Non-Small_Cell_Lung_Cancer\" >MAIA Biotechnology\u2019s Ateganosine Gets FDA Fast Track for Non-Small Cell Lung Cancer<\/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-ascendis-apellis-entera\/#Entera_Bio_Gets_FDA_Nod_on_BMD_as_Primary_Endpoint_for_Phase_3_Osteoporosis_Study\" >Entera Bio Gets FDA Nod on BMD as Primary Endpoint for Phase 3 Osteoporosis Study<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-ascendis-pharma-s-skytrofa-approved-by-fda-for-adult-growth-hormone-deficiency\"><span class=\"ez-toc-section\" id=\"Ascendis_Pharmas_SKYTROFA_Approved_by_FDA_for_Adult_Growth_Hormone_Deficiency\"><\/span>Ascendis Pharma\u2019s SKYTROFA Approved by FDA for Adult Growth Hormone Deficiency<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Ascendis Pharma A\/S <\/strong>announced that the FDA has approved <strong>SKYTROFA (lonapegsomatropin-tcgd)<\/strong> for the treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/adult-growth-hormone-deficiency-aghd-market\"><strong>adult growth hormone deficiency (GHD)<\/strong><\/a>. Already approved for pediatric GHD since 2021, SKYTROFA is a once-weekly prodrug of somatropin designed to provide sustained release of unmodified human growth hormone, offering a less burdensome alternative to daily injections.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis important milestone is the first of many planned label expansions supporting our goal to become the leading endocrinology rare disease company,\u201d said <\/em><strong><em>Jan Mikkelsen<\/em><\/strong><em>, President and CEO of Ascendis Pharma. \u201cWe are pleased to expand SKYTROFA\u2019s availability for adults initiating therapy or switching from existing treatment.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The FDA approval was based on positive data from the <strong>foresiGHt Phase III trial<\/strong>, a double-blind, placebo- and active-controlled study comparing weekly TransCon hGH with placebo and daily somatropin. Results demonstrated efficacy and safety benefits in adults with GHD.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cAdherence to daily injections remains a major issue in adult GHD,\u201d noted <\/em><strong><em>Dr. Kevin Yuen<\/em><\/strong><em>, endocrinologist at Barrow Neurological Institute. \u201cA once-weekly option like SKYTROFA may significantly improve both real-world adherence and patient outcomes, especially given the serious complications associated with this condition.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>SKYTROFA\u2019s approval highlights a major advancement in the treatment landscape for adult GHD, addressing a key unmet need in long-term endocrine care.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-apellis-wins-fda-approval-for-empaveli-in-c3g-and-ic-mpgn-treatment\"><span class=\"ez-toc-section\" id=\"Apellis_Wins_FDA_Approval_for_EMPAVELI_in_C3G_and_IC-MPGN_Treatment\"><\/span>Apellis Wins FDA Approval for EMPAVELI in C3G and IC-MPGN Treatment<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Apellis Pharmaceuticals<\/strong> announced that the FDA has approved <strong>EMPAVELI <\/strong>(pegcetacoplan) for the treatment of<strong> <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/complement-3-glomerulopathy-c3g-market\"><strong>C3 glomerulopathy (C3G)<\/strong><\/a><strong> <\/strong>and primary<strong> <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/immune-complex-membranoproliferative-glomerulonephritis-ic-mpgn-market\"><strong>immune complex membranoproliferative glomerulonephritis (IC-MPGN)<\/strong><\/a><strong> <\/strong>in patients aged 12 years and older to reduce proteinuria. These rare kidney diseases impact roughly 5,000 individuals in the U.S., often progressing to kidney failure without effective treatment.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis approval is a pivotal moment,\u201d said Dr. Carla Nester, lead investigator for the phase III VALIANT study and professor at the University of Iowa. \u201cPatients, especially children, now have access to a highly effective therapy that significantly reduces proteinuria and helps preserve kidney function.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The FDA\u2019s decision is supported by positive data from the VALIANT study, where EMPAVELI demonstrated a 68% reduction in proteinuria, stabilization of kidney function, and clearance of C3 deposits. These benefits were observed across adolescent and adult populations, including those with post-transplant recurrence.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cEMPAVELI\u2019s approval marks our third in four years and validates the potential of C3 inhibition to alter the course of rare diseases,\u201d said Dr. Cedric Francois, CEO of Apellis. \u201cWe\u2019re proud to bring this transformational therapy to patients and plan to advance its use in other renal indications.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p><em>Josh Tarnoff, CEO of NephCure, added, \u201cThis is a historic milestone for the C3G and IC-MPGN communities. Apellis\u2019 commitment to these underserved patients is commendable.\u201d<\/em><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-approves-ptc-therapeutics-sephience-for-phenylketonuria-pku\"><span class=\"ez-toc-section\" id=\"FDA_Approves_PTC_Therapeutics_Sephience_for_Phenylketonuria_PKU\"><\/span>FDA Approves PTC Therapeutics\u2019 Sephience for Phenylketonuria (PKU)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>PTC Therapeutics<\/strong> has received FDA approval for <strong>SEPHIENCE (sepiapterin)<\/strong> for the treatment of <strong>hyperphenylalaninemia (HPA)<\/strong> in both children and adults with <a href=\"https:\/\/www.delveinsight.com\/report-store\/phenylketonuria-pku-market\"><strong>sepiapterin-responsive phenylketonuria (PKU)<\/strong><\/a>. The approval grants <strong>broad labeling<\/strong> for patients aged 1 month and older, marking a significant advancement in the treatment landscape for PKU.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe broad labeling reflects the potential of SEPHIENCE to meet the significant unmet need of PKU patients,\u201d said <\/em><strong><em>Dr. Matthew B. Klein<\/em><\/strong><em>, CEO of PTC Therapeutics. \u201cOur experienced customer-facing teams are ready to bring this therapy to children and adults in the U.S. as quickly as possible.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The FDA\u2019s decision was supported by robust data from the phase III APHENITY trial and its long-term extension study, both of which demonstrated durable efficacy and safety. The approval also follows marketing authorization in the European Union, and regulatory reviews are underway in other major markets, including Japan and Brazil.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis approval marks an exciting milestone for the PKU community,\u201d said Catherine Warren, Executive Director of the National PKU Alliance. \u201cWe are eager to see the positive impact this new treatment option will have on advancing care and improving quality of life for patients of all ages and PKU subtypes.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-maia-biotechnology-s-ateganosine-gets-fda-fast-track-for-non-small-cell-lung-cancer\"><span class=\"ez-toc-section\" id=\"MAIA_Biotechnologys_Ateganosine_Gets_FDA_Fast_Track_for_Non-Small_Cell_Lung_Cancer\"><\/span>MAIA Biotechnology\u2019s Ateganosine Gets FDA Fast Track for Non-Small Cell Lung Cancer<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>MAIA Biotechnology<\/strong> has received Fast Track designation from the FDA for its lead candidate, <em>ateganosine<\/em> (also known as THIO or 6-thio-dG), for the treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/non-small-cell-lung-cancer-nsclc-market\"><strong>non-small cell lung cancer (NSCLC)<\/strong><\/a><strong>. <\/strong>The investigational first-in-class small molecule is currently being evaluated in the pivotal phase II THIO-101 trial, where it is administered prior to a checkpoint inhibitor.<\/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 milestone for MAIA\u2019s clinical development program,\u201d said K. Robinson Lewis, Vice President and Head of Regulatory and Quality at MAIA. \u201cAteganosine has shown strong preclinical efficacy and encouraging survival data compared to current FDA-approved therapies for NSCLC.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Designed to disrupt telomere structure and function in cancer cells, ateganosine works through telomerase-mediated activity to overcome resistance to immune checkpoint inhibitors. As of May 15, 2025, the median overall survival in the ongoing THIO-101 study was reported at 17.8 months, with the longest surviving patient reaching 24.3 months, far surpassing the historical benchmark of 5\u20136 months in similar NSCLC populations.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cIf we are successful in this Fast Track pathway, ateganosine could receive accelerated approval and first-to-market status in a $34 billion NSCLC market,\u201d noted Dr. Vlad Vitoc, Chairman and CEO of MAIA. \u201cIt has the potential to reshape how we approach NSCLC treatment and bring real hope to patients facing poor prognoses.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-entera-bio-gets-fda-nod-on-bmd-as-primary-endpoint-for-phase-3-osteoporosis-study\"><span class=\"ez-toc-section\" id=\"Entera_Bio_Gets_FDA_Nod_on_BMD_as_Primary_Endpoint_for_Phase_3_Osteoporosis_Study\"><\/span>Entera Bio Gets FDA Nod on BMD as Primary Endpoint for Phase 3 Osteoporosis Study<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Entera Bio Ltd. <\/strong>has secured alignment with the <strong>FDA <\/strong>for the design of its<strong> registrational phase III trial <\/strong>of <strong>EB613<\/strong>, marking a significant regulatory milestone for the company and the <a href=\"https:\/\/www.delveinsight.com\/report-store\/osteoporosis-market\"><strong>osteoporosis treatment landscape<\/strong><\/a>. In a written response to a Type A meeting request, the FDA agreed that a single, multinational, randomized, double-blind, placebo-controlled phase III study evaluating total hip bone mineral density (BMD) as the primary endpoint and vertebral fracture incidence as the key secondary endpoint would be sufficient to support a future New Drug Application (NDA).<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis regulatory update is a major milestone for Entera and the entire osteoporosis community,\u201d stated Miranda Toledano, CEO of Entera Bio. \u201cOur alignment with the FDA reflects the strength of our data and collaborative discussions. Importantly, it allows us to advance without waiting for the FDA\u2019s qualification of SABRE, which is still expected later this year.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>This agreement departs from previous regulatory precedent, where phase III osteoporosis trials typically required fracture incidence as the primary endpoint, often extending trial timelines and raising cost and ethical hurdles. By accepting BMD as the primary endpoint, the FDA opens the door for a more streamlined path to innovation in osteoporosis drug development.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cOsteoporosis afflicts more women than heart attack, stroke, and breast cancer combined,\u201d added Toledano. \u201cWith over 200 million women affected globally and few treatment innovations in recent years, EB613\u2014our first-in-class oral, once-daily anabolic tablet\u2014has the potential to address a significant unmet need by increasing skeletal mass, improving bone microarchitecture, and reducing fracture risk.\u201d<\/em><\/p>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>Ascendis Pharma\u2019s SKYTROFA Approved by FDA for Adult Growth Hormone Deficiency Ascendis Pharma A\/S announced that the FDA has approved SKYTROFA (lonapegsomatropin-tcgd) for the treatment of adult growth hormone deficiency (GHD). Already approved for pediatric GHD since 2021, SKYTROFA is a once-weekly prodrug of somatropin designed to provide sustained release of unmodified human growth hormone, [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":32919,"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":[21800,137,16738,21782,204,704,19044,349,420,6733,12556,21479,1500,3278,3280,639,18821,18822,18823],"industry":[17225],"therapeutic_areas":[17240,17230,17241,17228],"class_list":["post-32918","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-adult-growth-hormone-deficiency","tag-cancer","tag-complement-3-glomerulopathy","tag-complement-3-glomerulopathy-treatment","tag-delveinsight","tag-fda","tag-growth-hormone-deficiency","tag-latest-pharma-news","tag-news","tag-non-small-cell-lung-cancer","tag-non-small-cell-lung-cancer-epidemiology","tag-non-small-cell-lung-cancer-treatment","tag-osteoporosis","tag-osteoporosis-market","tag-osteoporosis-treatment","tag-pharma-news","tag-phenylketonuria","tag-phenylketonuria-market","tag-phenylketonuria-pipeline","industry-pharmaceutical","therapeutic_areas-endocrinology-and-metabolic-disorders","therapeutic_areas-genito-urinary-system-and-sex-hormones","therapeutic_areas-musculoskeletal","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 | Ascendis, Apellis, Entera<\/title>\n<meta name=\"description\" content=\"Ascendis Pharma\u2019s SKYTROFA; Apellis\u2019 EMPAVELI; PTC Therapeutics\u2019 Sephience; MAIA Biotechnology\u2019s Ateganosine; Entera Bio\u2019s EB613\" \/>\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-ascendis-apellis-entera\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Ascendis, Apellis, Entera\" \/>\n<meta property=\"og:description\" content=\"Ascendis Pharma\u2019s SKYTROFA; Apellis\u2019 EMPAVELI; PTC Therapeutics\u2019 Sephience; MAIA Biotechnology\u2019s Ateganosine; Entera 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