{"id":30588,"date":"2024-12-17T16:52:54","date_gmt":"2024-12-17T11:22:54","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=30588"},"modified":"2024-12-17T16:52:56","modified_gmt":"2024-12-17T11:22:56","slug":"pharma-news-for-neurocrine-checkpoint-maia","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-neurocrine-checkpoint-maia","title":{"rendered":"FDA Approves Neurocrine\u2019s CRENESSITY for Congenital Adrenal Hyperplasia; Checkpoint\u2019s UNLOXCYT Approved; MAIA\u2019s THIO Gets Rare Pediatric Disease Designation; JEMPERLI\u00a0 Receives Breakthrough Therapy for Rectal Cancer; Galderma\u2019s NEMLUVIO Approved for Atopic Dermatitis."},"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-6a03dc1e4bed4\" 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-6a03dc1e4bed4\"  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-neurocrine-checkpoint-maia\/#Neurocrine_Announces_FDA_Approval_of_CRENESSITY_for_Congenital_Adrenal_Hyperplasia\" >Neurocrine Announces FDA Approval of CRENESSITY for Congenital Adrenal Hyperplasia<\/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-neurocrine-checkpoint-maia\/#Checkpoint_Therapeutics_Announces_FDA_Approval_of_UNLOXCYT\" >Checkpoint Therapeutics Announces FDA Approval of UNLOXCYT<\/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-neurocrine-checkpoint-maia\/#MAIA_Biotechnology_Receives_FDA_Rare_Pediatric_Disease_Designation_for_THIO\" >MAIA Biotechnology Receives FDA Rare Pediatric Disease Designation for THIO<\/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-neurocrine-checkpoint-maia\/#JEMPERLI_gets_FDA_Breakthrough_Therapy_Designation_for_Rectal_Cancer\" >JEMPERLI&nbsp; gets FDA Breakthrough Therapy Designation for Rectal 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-neurocrine-checkpoint-maia\/#Galderma_Announces_FDA_Approval_of_NEMLUVIO_for_Atopic_Dermatitis\" >Galderma Announces FDA Approval of NEMLUVIO for Atopic Dermatitis<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-neurocrine-announces-fda-approval-of-crenessity-for-congenital-adrenal-hyperplasia\"><span class=\"ez-toc-section\" id=\"Neurocrine_Announces_FDA_Approval_of_CRENESSITY_for_Congenital_Adrenal_Hyperplasia\"><\/span>Neurocrine Announces FDA Approval of CRENESSITY for Congenital Adrenal Hyperplasia<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Neurocrine Biosciences, Inc. announced that the FDA has approved <strong>CRENESSITY\u2122 (crinecerfont)<\/strong> as an adjunctive treatment to glucocorticoid replacement for controlling androgens in adult and pediatric <a href=\"https:\/\/www.delveinsight.com\/report-store\/congenital-adrenal-hyperplasia-market\" class=\"ek-link\">patients aged four years and older with classic congenital adrenal hyperplasia.<\/a> CRENESSITY, a potent oral CRF1 receptor antagonist, is the first therapy of its kind to directly reduce excess ACTH and downstream androgen production, enabling glucocorticoid dose reduction.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;The approval of CRENESSITY is a significant milestone for the CAH community,&#8221; said <\/em><strong><em>Kyle W. Gano, Ph.D., CEO of Neurocrine Biosciences.<\/em><\/strong><em> &#8220;We are grateful to patients, caregivers, and investigators who contributed to this breakthrough, advancing a new class of medicine for classic CAH.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Supported by the <strong>CAHtalyst Phase III clinical trials<\/strong>, the largest-ever program in CAH, CRENESSITY demonstrated significant reductions in adrenal androgens and glucocorticoid doses in both pediatric and adult patients. In pediatric patients, CRENESSITY reduced <strong>androstenedione levels<\/strong> approximately four times more than placebo, while enabling meaningful glucocorticoid dose reductions. Adults taking CRENESSITY achieved up to an eight-fold greater reduction in <strong>androstenedione levels<\/strong> compared to placebo, with 63% reaching glucocorticoid doses within the physiologic range.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;Patients with CAH struggle to balance symptoms and the side effects of high-dose steroids, impacting their quality of life,&#8221; said <\/em><strong><em>Dina Matos, Executive Director of CARES Foundation.<\/em><\/strong><em> &#8220;CRENESSITY offers new hope, reducing androgen excess and steroid dependence.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>CRENESSITY is expected to launch within a week through PANTHERx Rare specialty pharmacy, with comprehensive patient support through <strong>Neurocrine Access Support.<\/strong> Most patients will pay $10 or less per month for the medication.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-checkpoint-therapeutics-announces-fda-approval-of-unloxcyt\"><span class=\"ez-toc-section\" id=\"Checkpoint_Therapeutics_Announces_FDA_Approval_of_UNLOXCYT\"><\/span>Checkpoint Therapeutics Announces FDA Approval of UNLOXCYT<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Checkpoint Therapeutics, Inc. announced that the FDA has approved <strong>UNLOXCYT\u2122 (cosibelimab-ipdl)<\/strong> for <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-cutaneous-squamous-cell-carcinoma-market\" class=\"ek-link\">adults with metastatic cutaneous squamous cell carcinoma<\/a> or locally advanced cSCC who are not candidates for curative surgery or radiation. UNLOXCYT is the first FDA-approved <strong>PD-L1\u2013blocking antibody<\/strong> for this indication, offering a differentiated treatment option with its ability to induce antibody-dependent cell-mediated cytotoxicity (ADCC).<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cToday\u2019s approval of UNLOXCYT marks a significant milestone for both Checkpoint and patients with advanced cSCC,\u201d said <\/em><strong><em>James Oliviero, CEO of Checkpoint Therapeutics.<\/em><\/strong><em> \u201cThis positions us to compete in a U.S. market exceeding $1 billion annually, providing a unique therapy that binds to PD-L1 to restore anti-tumor immune response.\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><em>UNLOXCYT\u2019s approval is supported by objective response rates and durable responses observed in the <\/em><strong><em>CK-301-101 trial<\/em><\/strong><em>. \u201cPatients with advanced cSCC, particularly those with comorbidities, face limited treatment options,\u201d said <\/em><strong><em>Dr. Emily Ruiz<\/em><\/strong><em> of Harvard Medical School. \u201cUNLOXCYT\u2019s safety profile and efficacy represent a promising new immunotherapy for oncologists.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Checkpoint is preparing for the commercial launch of UNLOXCYT, with the recommended dosage being <strong>1,200 mg via intravenous infusion every three weeks.<\/strong> Mr. Oliviero expressed gratitude to patients, physicians, and the FDA for their role in achieving this critical approval.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-maia-biotechnology-receives-fda-rare-pediatric-disease-designation-for-thio\"><span class=\"ez-toc-section\" id=\"MAIA_Biotechnology_Receives_FDA_Rare_Pediatric_Disease_Designation_for_THIO\"><\/span>MAIA Biotechnology Receives FDA Rare Pediatric Disease Designation for THIO<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>MAIA Biotechnology, Inc. announced that the FDA has granted <strong>Rare Pediatric Disease Designation<\/strong> to <strong>THIO<\/strong> for <a href=\"https:\/\/www.delveinsight.com\/report-store\/high-grade-glioma-hgg-market\" class=\"ek-link\">the treatment of pediatric-type diffuse high-grade gliomas<\/a>, one of the most treatment-resistant childhood cancers. THIO, a novel anti-cancer agent, activates the immune system while overcoming tumor immunosuppression, presenting a promising therapeutic option.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cTHIO has demonstrated positive results in treating difficult cancers, including pediatric high-grade gliomas,\u201d said <\/em><strong><em>Vlad Vitoc, M.D., Chairman and CEO of MAIA.<\/em><\/strong><em> \u201cThis designation strengthens our commitment to advancing research for this devastating childhood disease.\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><em>K. Robinson Lewis, MAIA\u2019s Vice President and Head of Regulatory, emphasized the value of this designation, as it makes MAIA eligible for a <\/em><strong><em>priority review voucher (PRV)<\/em><\/strong><em> upon FDA approval. PRVs, which can be redeemed or sold, have historically commanded valuations averaging $100 million.<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>THIO has previously shown strong efficacy in <strong>diffuse intrinsic pontine glioma (DIPG)<\/strong> in preclinical studies, particularly when combined with ionizing radiation. The promising results were presented at the <strong>2024 AACR Annual Meeting<\/strong>. In addition to PDHGG, THIO holds <strong>orphan drug designations<\/strong> for hepatocellular carcinoma, small cell lung cancer, and glioblastoma.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-jemperli-nbsp-gets-fda-breakthrough-therapy-designation-for-rectal-cancer\"><span class=\"ez-toc-section\" id=\"JEMPERLI_gets_FDA_Breakthrough_Therapy_Designation_for_Rectal_Cancer\"><\/span>JEMPERLI&nbsp; gets FDA Breakthrough Therapy Designation for Rectal Cancer<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>GSK plc announced that the <strong>FDA has granted Breakthrough Therapy Designation<\/strong> to <strong>JEMPERLI&nbsp; (dostarlimab)<\/strong> for the treatment of patients with <strong>locally advanced mismatch repair deficient (dMMR)\/microsatellite instability-high (MSI-H) rectal cancer<\/strong>. This designation accelerates the development of therapies with significant potential to improve treatment outcomes for serious conditions. It follows the <strong>Fast Track designation<\/strong> for the same indication in January 2023.<\/p>\n\n\n\n<p>The designation is based on results from a <strong>Phase II trial<\/strong> conducted in collaboration with Memorial Sloan Kettering Cancer Center, where <strong>100% of 42 patients<\/strong> completing dostarlimab treatment achieved a <strong>clinical complete response (cCR)<\/strong> with no evidence of tumors. \u201cToday\u2019s designation, based on this unprecedented response rate, supports a path to change the treatment paradigm for patients facing significant long-term quality-of-life effects,\u201d said <strong>Hesham Abdullah, SVP, Global Head Oncology, R&amp;D, GSK<\/strong>.<\/p>\n\n\n\n<p>Current standard treatment involves chemotherapy, radiation, and surgery, which can result in long-term complications such as bowel dysfunction, infertility, and secondary cancers. GSK\u2019s ongoing <strong>AZUR-1 registrational trial<\/strong> aims to confirm the promising results of dostarlimab as a potential frontline therapy for this patient population, offering new hope for improved outcomes and quality of life.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-galderma-announces-fda-approval-of-nemluvio-for-atopic-dermatitis\"><span class=\"ez-toc-section\" id=\"Galderma_Announces_FDA_Approval_of_NEMLUVIO_for_Atopic_Dermatitis\"><\/span>Galderma Announces FDA Approval of NEMLUVIO for Atopic Dermatitis<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Galderma announced that the <strong>FDA has approved NEMLUVIO (nemolizumab)<\/strong> for the treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/atopic-dermatitis-market\" class=\"ek-link\">patients aged <strong>12 and older with moderate-to-severe <\/strong><\/a><strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/atopic-dermatitis-market\" class=\"ek-link\">atopic dermatitis<\/a><\/strong>, in combination with topical corticosteroids (TCS) and\/or calcineurin inhibitors (TCI). This approval follows NEMLUVIO\u2019s earlier FDA approval in August 2024 for adults with <strong>prurigo nodularis<\/strong>, further expanding its therapeutic reach.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cNEMLUVIO is an important and effective new treatment option for patients with atopic dermatitis, where unmet needs remain,\u201d said <\/em><strong><em>Flemming \u00d8rnskov, M.D., MPH, CEO of Galderma<\/em><\/strong><em>. \u201cThis FDA approval marks a significant milestone, underscoring our commitment to delivering innovative solutions to patients and accelerating the growth of our Therapeutic Dermatology Business.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The approval is based on positive results from the <strong>Phase III ARCADIA clinical trials<\/strong>, involving <strong>1,728 patients<\/strong>. The data showed that NEMLUVIO, administered <strong>subcutaneously every four weeks<\/strong>, achieved significant improvements in <strong>skin clearance<\/strong> and a <strong>75% reduction<\/strong> in the Eczema Area and Severity Index (EASI) at 16 weeks, compared to placebo. NEMLUVIO also delivered rapid <strong>itch relief as early as Week 1<\/strong> and significantly improved sleep disturbance.<\/p>\n\n\n\n<p>NEMLUVIO was well-tolerated, with a safety profile consistent across treatment and placebo groups. In addition to the FDA approval, the European Medicines Agency\u2019s (EMA) <strong>CHMP has issued a positive opinion<\/strong> recommending NEMLUVIO for atopic dermatitis and prurigo nodularis in Europe. Galderma anticipates peak sales for NEMLUVIO to exceed <strong>$2 billion<\/strong>, approaching \u201cblockbuster\u201d status by 2027.<\/p>\n\n\n\n<p>Galderma continues to seek approvals globally, with regulatory reviews underway in <strong>Australia, Canada, Brazil, South Korea<\/strong>, and other key markets.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Neurocrine Announces FDA Approval of CRENESSITY for Congenital Adrenal Hyperplasia Neurocrine Biosciences, Inc. announced that the FDA has approved CRENESSITY\u2122 (crinecerfont) as an adjunctive treatment to glucocorticoid replacement for controlling androgens in adult and pediatric patients aged four years and older with classic congenital adrenal hyperplasia. CRENESSITY, a potent oral CRF1 receptor antagonist, is the [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":30589,"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":[7478,19635,890,204,704,19550,349,420,639,5789,19415],"industry":[17225],"therapeutic_areas":[17237,17240,17228],"class_list":["post-30588","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-atopic-dermatitis","tag-congenital-adrenal-hyperplasia","tag-cutaneous-squamous-cell-carcinoma","tag-delveinsight","tag-fda","tag-high-grade-glioma","tag-latest-pharma-news","tag-news","tag-pharma-news","tag-recent-pharma-news","tag-rectal-cancer","industry-pharmaceutical","therapeutic_areas-dermatology","therapeutic_areas-endocrinology-and-metabolic-disorders","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 | Neurocrine, Checkpoint, MAIA<\/title>\n<meta name=\"description\" content=\"Neurocrine\u2019s CRENESSITY, Checkpoint\u2019s UNLOXCYT, MAIA\u2019s THIO, GSK plc\u2019s JEMPERLI , Galderma\u2019s NEMLUVIO for Atopic Dermatitis.\" \/>\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-neurocrine-checkpoint-maia\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Neurocrine, Checkpoint, MAIA\" \/>\n<meta property=\"og:description\" content=\"Neurocrine\u2019s CRENESSITY, Checkpoint\u2019s UNLOXCYT, MAIA\u2019s THIO, GSK plc\u2019s JEMPERLI , Galderma\u2019s NEMLUVIO for Atopic 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