{"id":34401,"date":"2026-01-27T17:01:00","date_gmt":"2026-01-27T11:31:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=34401"},"modified":"2026-01-27T15:02:50","modified_gmt":"2026-01-27T09:32:50","slug":"pharma-news-for-sanofi-corcept-corxel","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-sanofi-corcept-corxel","title":{"rendered":"Sanofi Strengthens Amlitelimab\u2019s Position in Atopic Dermatitis; Corcept Announces Statistically Significant Overall Survival Benefit in Phase 3 ROSELLA Study; CORXEL Raises $287M Series D1 for Cardiometabolic Pipeline Expansion; IntraBio\u2019s Levacetylleucine Demonstrates Positive Results in Pivotal Ataxia-Telangiectasia Trial; Otsuka Secures FDA Acceptance and Priority Review for Centanafadine in ADHD"},"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-69f13e530f871\" 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-69f13e530f871\"  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-sanofi-corcept-corxel\/#Sanofis_Amlitelimab_Demonstrates_Promise_in_Atopic_Dermatitis\" >Sanofi\u2019s Amlitelimab Demonstrates Promise in Atopic Dermatitis<\/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-sanofi-corcept-corxel\/#Corcept_Reports_Positive_Phase_3_ROSELLA_Results_with_Overall_Survival_Endpoint_Met_in_Platinum-Resistant_Ovarian_Cancer\" >Corcept Reports Positive Phase 3 ROSELLA Results with Overall Survival Endpoint Met in Platinum-Resistant Ovarian Cancer<\/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-sanofi-corcept-corxel\/#CORXEL_Strengthens_Cardiometabolic_Pipeline_with_287M_Series_D1_Financing_Highlighting_Oral_GLP-1_Program\" >CORXEL Strengthens Cardiometabolic Pipeline with $287M Series D1 Financing, Highlighting Oral GLP-1 Program<\/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-sanofi-corcept-corxel\/#IntraBio_Announces_Positive_Pivotal_Data_Supporting_Levacetylleucine_in_Ataxia-Telangiectasia\" >IntraBio Announces Positive Pivotal Data Supporting Levacetylleucine in Ataxia-Telangiectasia<\/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-sanofi-corcept-corxel\/#Otsukas_Centanafadine_NDA_Accepted_by_FDA_With_Priority_Review_for_ADHD_Across_Age_Groups\" >Otsuka\u2019s Centanafadine NDA Accepted by FDA With Priority Review for ADHD Across Age Groups<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-sanofi-s-amlitelimab-demonstrates-promise-in-atopic-dermatitis\"><span class=\"ez-toc-section\" id=\"Sanofis_Amlitelimab_Demonstrates_Promise_in_Atopic_Dermatitis\"><\/span>Sanofi\u2019s Amlitelimab Demonstrates Promise in Atopic Dermatitis<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following the positive findings from the <strong>COAST 1 trial (NCT06130566)<\/strong> reported in September 2025, two additional global Phase 3 studies, <strong>SHORE (NCT06224348) and COAST 2 (NCT06181435)<\/strong>, have further strengthened the clinical evidence supporting <strong>amlitelimab <\/strong>in patients aged 12 years and older with <a href=\"https:\/\/www.delveinsight.com\/report-store\/moderate-to-severe-atopic-dermatitis-market\">moderate-to-severe atopic dermatitis<\/a>. Amlitelimab is a fully human monoclonal antibody that selectively inhibits OX40-ligand (OX40L) without depleting T cells. Across both studies, amlitelimab demonstrated favorable tolerability, with a safety profile consistent with previously reported results.<\/p>\n\n\n\n<p><em>\u201cThese findings underscore the validity of amlitelimab\u2019s differentiated mechanism of action, blocking OX40-ligand without T-cell depletion, and its potential to progressively rebalance immune function,\u201d said Houman Ashrafian, Executive Vice President and Head of Research &amp; Development at Sanofi. \u201cThe cumulative data to date reinforce our confidence in amlitelimab\u2019s ability to provide Q12W dosing from treatment initiation while delivering increasing efficacy through Week 52. We look forward to presenting additional outcomes, including long-term data, as we advance toward global regulatory filings.\u201d<\/em><\/p>\n\n\n\n<p>In both the SHORE and COAST 2 Phase 3 trials, primary efficacy assessments were conducted at Week 24 in adolescents and adults with moderate-to-severe AD receiving amlitelimab either every four weeks (Q4W) or every 12 weeks (Q12W). In the US and US reference countries, the primary endpoint was the proportion of patients achieving a validated Investigator Global Assessment for AD (vIGA-AD) score of 0 (clear) or 1 (almost clear) with\u22652-point improvement from baseline, analyzed using a non-responder imputation approach (US estimand). In the EU, EU reference countries, and Japan, the co-primary endpoints included both the proportion of patients achieving vIGA-AD 0\/1 with a \u22652-point reduction from baseline and the proportion achieving at least a 75% improvement in Eczema Area and Severity Index (EASI-75), analyzed using a treatment-policy estimand (EU estimand).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-corcept-reports-positive-phase-3-rosella-results-with-overall-survival-endpoint-met-in-platinum-resistant-ovarian-cancer\"><span class=\"ez-toc-section\" id=\"Corcept_Reports_Positive_Phase_3_ROSELLA_Results_with_Overall_Survival_Endpoint_Met_in_Platinum-Resistant_Ovarian_Cancer\"><\/span>Corcept Reports Positive Phase 3 ROSELLA Results with Overall Survival Endpoint Met in Platinum-Resistant Ovarian Cancer<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Corcept Therapeutics<\/strong> <strong>Incorporated <\/strong>announced positive results from the <strong>ROSELLA pivotal Phase 3 study<\/strong> evaluating relacorilant in combination with nab-paclitaxel in patients with <a href=\"https:\/\/www.delveinsight.com\/report-store\/platinum-resistant-ovarian-cancer-market\">platinum-resistant ovarian cancer<\/a>. The trial successfully achieved its primary endpoint of overall survival (OS).<\/p>\n\n\n\n<p>In the ROSELLA study, the addition of relacorilant to nab-paclitaxel reduced the risk of death by 35% compared with nab-paclitaxel alone (hazard ratio: 0.65; p=0.0004). Median overall survival reached 16.0 months in the combination arm versus 11.9 months in the chemotherapy-only arm, representing an improvement of 4.1 months. The relacorilant and nab-paclitaxel regimen was generally well tolerated and aligned with the drug\u2019s established safety profile. The incidence, nature, and severity of adverse events were comparable between the combination therapy and monotherapy groups, indicating that relacorilant delivered clinical benefit without adding to patients\u2019 safety burden.<\/p>\n\n\n\n<p>Previously, Corcept reported that ROSELLA also met its primary endpoint for progression-free survival as determined by blinded independent central review (PFS-BICR). Patients treated with relacorilant plus nab-paclitaxel demonstrated a 30% reduction in the risk of disease progression compared with those receiving nab-paclitaxel alone (hazard ratio: 0.70; p=0.008). These data were initially presented at the <a href=\"https:\/\/www.delveinsight.com\/asco-conference-2025\"><strong>2025 American Society of Clinical Oncology (ASCO) Annual Meeting<\/strong><\/a> and published concurrently in The Lancet. Full study results will be shared at a forthcoming scientific conference.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-corxel-strengthens-cardiometabolic-pipeline-with-287m-series-d1-financing-highlighting-oral-glp-1-program\"><span class=\"ez-toc-section\" id=\"CORXEL_Strengthens_Cardiometabolic_Pipeline_with_287M_Series_D1_Financing_Highlighting_Oral_GLP-1_Program\"><\/span>CORXEL Strengthens Cardiometabolic Pipeline with $287M Series D1 Financing, Highlighting Oral GLP-1 Program<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Corxel Pharmaceuticals Limited<\/strong> has announced the successful close of its <strong>Series D1 financing<\/strong> round, securing up to <strong>$287 million<\/strong>. The funds will primarily support the continued development of CX11, a differentiated oral small-molecule <a href=\"https:\/\/www.delveinsight.com\/report-store\/glucagon-like-peptide1-glp1-agonists-market-forecast\">GLP-1 receptor agonist<\/a> for the treatment of obesity and overweight. <strong>CX11<\/strong> is currently being assessed in a Phase 2 clinical study led by CORXEL in the United States and a Phase 3 trial conducted by Vincentage in China. Additional proceeds will be allocated to advance other cardiometabolic programs, including those targeting acute ischemic stroke and hypertension.<\/p>\n\n\n\n<p>The financing round attracted a strong group of new investors, including <strong>SR One, TCGX, RA Capital Management, HBM Healthcare Investments, SymBiosis, Adage Capital Management, Invus, SilverArc Capital<\/strong>, and other participants. Existing shareholders RTW Investments and Hengdian Group Capital also contributed, reflecting continued confidence in CX11\u2019s differentiated clinical potential, CORXEL\u2019s execution capabilities, and its long-term strategic vision.<\/p>\n\n\n\n<p>Capital raised in this round will be used to:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Progress CX11 through its ongoing Phase 2 clinical trial in the U.S. for obesity and overweight, initiate a planned global Phase 2 study in Type 2 Diabetes Mellitus (T2DM), and support early preparations for Phase 3 development;<\/li>\n\n\n\n<li>Advance the company\u2019s broader pipeline through clinical development; and<\/li>\n\n\n\n<li>Further enhance CORXEL\u2019s global development and operational infrastructure to enable multiregional clinical programs.<\/li>\n<\/ul>\n\n\n\n<p><em>\u201cThis investment marks one of the most important milestones in CORXEL\u2019s journey since its inception. It strengthens our ability to accelerate the global development of best-in-class therapies for cardiometabolic diseases while positioning the company for its next phase of transformative growth,\u201d said Sandy Mou, Board Executive Director and Chief Executive Officer of CORXEL. \u201cWe deeply appreciate the trust shown by both our existing and new investors, and our determination to build CORXEL into a leading global biopharmaceutical company has never been stronger.\u201d<\/em><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-intrabio-announces-positive-pivotal-data-supporting-levacetylleucine-in-ataxia-telangiectasia\"><span class=\"ez-toc-section\" id=\"IntraBio_Announces_Positive_Pivotal_Data_Supporting_Levacetylleucine_in_Ataxia-Telangiectasia\"><\/span>IntraBio Announces Positive Pivotal Data Supporting Levacetylleucine in Ataxia-Telangiectasia<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>IntraBio Inc.<\/strong> announced positive topline findings from its pivotal <strong>Phase III IB1001-303 clinical study<\/strong> titled <strong>\u201cEffects of N-Acetyl-L-Leucine on Ataxia-Telangiectasia (A-T): A Randomized, Placebo-Controlled, Double-Blind, Crossover Study\u201d (NCT06673056)<\/strong>. The trial evaluated N-acetyl-L-leucine (levacetylleucine) in both <a href=\"https:\/\/www.delveinsight.com\/report-store\/ataxia-telangiectasia-at-market\">pediatric and adult patients with Ataxia-Telangiectasia<\/a>.<\/p>\n\n\n\n<p>The study\u2019s primary endpoint assessed the impact of levacetylleucine on the Scale for the Assessment and Rating of Ataxia (SARA) versus placebo after 12 weeks of treatment. Results showed a statistically significant and clinically meaningful improvement, with a 1.88-point greater reduction in SARA score compared with placebo (-1.92 for levacetylleucine vs. -0.14 for placebo; p&lt;0.001).<\/p>\n\n\n\n<p>Secondary endpoints were also successfully achieved, demonstrating significant improvements on the International Cooperative Ataxia Rating Scale (ICARS) (-4.22 with levacetylleucine vs. -1.69 with placebo; p=0.003) and the Investigator\u2019s Clinical Global Impression of Improvement (CGI-I) (-0.6 vs. -0.2, respectively; p=0.02). Levacetylleucine was found to be safe and well-tolerated, with no drug-related serious adverse events reported, in line with its known safety profile.<\/p>\n\n\n\n<p>In light of these positive results, IntraBio intends to promptly proceed with regulatory filings with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulatory agencies worldwide.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-otsuka-s-centanafadine-nda-accepted-by-fda-with-priority-review-for-adhd-across-age-groups\"><span class=\"ez-toc-section\" id=\"Otsukas_Centanafadine_NDA_Accepted_by_FDA_With_Priority_Review_for_ADHD_Across_Age_Groups\"><\/span>Otsuka\u2019s Centanafadine NDA Accepted by FDA With Priority Review for ADHD Across Age Groups<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Otsuka Pharmaceutical Co., Ltd., together with Otsuka Pharmaceutical Development &amp; Commercialization, Inc.<\/strong>, has announced that the FDA has granted priority review and accepted the New Drug Application (NDA) for <strong>centanafadine<\/strong>. Centanafadine is an investigational, once-daily extended-release oral capsule and a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI) being developed for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/attention-deficit-hyperactivity-disorder-adhd-market\">treatment of attention-deficit hyperactivity disorder (ADHD)<\/a> in pediatric, adolescent, and adult patients. The FDA has assigned a <strong>Prescription Drug User Fee Act (PDUFA) target action date of July 24, 2026<\/strong>.<\/p>\n\n\n\n<p>The NDA submission is based on data from four pivotal Phase 3 clinical studies that assessed the efficacy and safety of centanafadine across different age groups. In these trials, centanafadine produced statistically significant and clinically meaningful reductions in ADHD symptoms compared with placebo. Symptom improvement was evaluated using the ADHD Rating Scale-5 (ADHD-RS-5) in children and adolescents and the ADHD Investigator Symptom Rating Scale (AISRS) in adults. Across studies, centanafadine demonstrated a favorable tolerability profile. The most frequently reported adverse events in pediatric and adolescent patients included decreased appetite, nausea, rash, fatigue, abdominal pain, and somnolence, while adults most commonly experienced decreased appetite and headache.<\/p>\n\n\n\n<p><em>\u201cADHD presents with considerable variability among individuals, underscoring the need for a range of treatment options,\u201d said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka Pharmaceutical Development &amp; Commercialization, Inc. \u201cThe FDA\u2019s acceptance and priority review of the centanafadine NDA represents a meaningful step toward introducing a novel therapeutic approach for people living with ADHD. If approved, centanafadine would be the first NDSRI available, offering a new option for comprehensive symptom management. We are deeply thankful to the patients, caregivers, and clinical investigators whose contributions made this progress possible.\u201d<\/em><\/p>\n\n\n\n<p>While ADHD has traditionally been viewed as a pediatric condition, growing evidence indicates that a substantial proportion of individuals diagnosed in childhood continue to experience symptoms into adulthood, often resulting in significant functional impairment.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sanofi\u2019s Amlitelimab Demonstrates Promise in Atopic Dermatitis Following the positive findings from the COAST 1 trial (NCT06130566) reported in September 2025, two additional global Phase 3 studies, SHORE (NCT06224348) and COAST 2 (NCT06181435), have further strengthened the clinical evidence supporting amlitelimab in patients aged 12 years and older with moderate-to-severe atopic dermatitis. Amlitelimab is a [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":34402,"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":[22859,7478,19300,22409,349,444,639],"industry":[17225],"therapeutic_areas":[17237,17240,17228],"class_list":["post-34401","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-ataxia-telangiectasia","tag-atopic-dermatitis","tag-attention-deficit-hyperactivity-disorder-3","tag-glp-1-receptor","tag-latest-pharma-news","tag-ovarian-cancer","tag-pharma-news","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 | Sanofi, Corcept, CORXEL<\/title>\n<meta name=\"description\" content=\"Sanofi\u2019s Amlitelimab; Corcept\u2019s Phase 3 ROSELLA Results; CORXEL\u2019s Series D1 Financing; IntraBio\u2019s Levacetylleucine; Otsuka\u2019s Centanafadine\" \/>\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-sanofi-corcept-corxel\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Sanofi, Corcept, CORXEL\" \/>\n<meta property=\"og:description\" content=\"Sanofi\u2019s Amlitelimab; Corcept\u2019s Phase 3 ROSELLA Results; CORXEL\u2019s Series D1 Financing; IntraBio\u2019s Levacetylleucine; 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