{"id":34595,"date":"2026-02-24T17:44:00","date_gmt":"2026-02-24T12:14:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=34595"},"modified":"2026-02-25T08:56:45","modified_gmt":"2026-02-25T03:26:45","slug":"pharma-news-for-gilead-novo-vanda","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-gilead-novo-vanda","title":{"rendered":"Gilead Sciences to Acquire Arcellx in Strategic Move to Accelerate Anito-cel Development; Novo Nordisk Faces Setback as CagriSema Underwhelms Against Rival Therapy in Trial; Vanda Pharmaceuticals Secures FDA Approval for BYSANTI; All-oral Calquence + venetoclax Combo Clears in the US for First-line Treatment of CLL; Merck\u2019s ENFLONSIA Demonstrates Strong Protection Against Severe RSV in Young Children Over Consecutive Seasons"},"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-69dec1dd79d23\" 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-69dec1dd79d23\"  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-gilead-novo-vanda\/#Gilead_Sciences_Announces_Acquisition_of_Arcellx_to_Advance_Long-Term_Growth_of_Anito-cel\" >Gilead Sciences Announces Acquisition of Arcellx to Advance Long-Term Growth of Anito-cel<\/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-gilead-novo-vanda\/#Novos_CagriSema_Fails_to_Match_Performance_of_Eli_Lillys_ZEPBOUND_in_Trial\" >Novo\u2019s CagriSema Fails to Match Performance of Eli Lilly\u2019s ZEPBOUND in Trial<\/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-gilead-novo-vanda\/#Vanda_Pharmaceuticals_Receives_FDA_Approval_of_BYSANTI_for_Bipolar_I_Disorder_and_Schizophrenia\" >Vanda Pharmaceuticals Receives FDA Approval of BYSANTI for Bipolar I Disorder and Schizophrenia<\/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-gilead-novo-vanda\/#US_Approves_Calquence_with_Venetoclax_as_the_First_Fixed-duration_All-oral_Frontline_Option_for_CLL\" >US Approves Calquence with Venetoclax as the First Fixed-duration, All-oral Frontline Option for CLL<\/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-gilead-novo-vanda\/#Mercks_ENFLONSIA_Exhibits_Sustained_Efficacy_in_Preventing_Severe_RSV_in_At-Risk_Infants_Over_Two_Seasons\" >Merck\u2019s ENFLONSIA Exhibits Sustained Efficacy in Preventing Severe RSV in At-Risk Infants Over Two Seasons<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-gilead-sciences-announces-acquisition-of-arcellx-to-advance-long-term-growth-of-anito-cel\"><span class=\"ez-toc-section\" id=\"Gilead_Sciences_Announces_Acquisition_of_Arcellx_to_Advance_Long-Term_Growth_of_Anito-cel\"><\/span>Gilead Sciences Announces Acquisition of Arcellx to Advance Long-Term Growth of Anito-cel<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Gilead Sciences<\/strong> announced a definitive agreement to acquire <strong>Arcellx<\/strong>, a clinical-stage biotechnology company, in a strategic move to strengthen its leadership in cell therapy and oncology innovation. The acquisition builds on an existing collaboration between the two companies focused on <strong>anito-cel (anitocabtagene autoleucel)<\/strong>, a next-generation <a href=\"https:\/\/www.delveinsight.com\/report-store\/bcma-targeted-therapies-market-forecast\">BCMA-directed CAR-T therapy<\/a> being developed for patients with relapsed or refractory multiple myeloma. Under the terms of the transaction, Gilead will acquire all outstanding shares of Arcellx for a cash consideration, along with a contingent value right (CVR) tied to future commercial performance, reflecting confidence in the therapy\u2019s long-term revenue potential.<\/p>\n\n\n\n<p>Anito-cel has demonstrated compelling clinical data, including deep and durable responses with a favorable safety profile, addressing limitations seen in earlier CAR-T therapies such as high toxicity and manufacturing complexity. The U.S. Food and Drug Administration (FDA) has already accepted the biologics license application (BLA) for anito-cel, with regulatory decisions anticipated in 2026. Full ownership of Arcellx will allow Gilead to streamline development, manufacturing, and commercialization, while eliminating profit-sharing obligations associated with the prior partnership.<\/p>\n\n\n\n<p>Beyond anito-cel, the acquisition provides Gilead with access to Arcellx\u2019s proprietary <strong>D-Domain CAR platform<\/strong>, a differentiated technology that may enable more precise and flexible cell therapy designs across multiple oncology indications. This platform is viewed as a strategic asset that could support the development of next-generation CAR-T therapies and potentially expand into autoimmune and inflammatory diseases.<\/p>\n\n\n\n<p>From a financial perspective, Gilead expects the transaction to be accretive to earnings by the latter part of the decade, assuming successful approval and commercialization of anito-cel. The acquisition also reinforces Gilead\u2019s broader oncology strategy, complementing its existing cell therapy portfolio and positioning the company to compete more effectively in the rapidly evolving hematologic malignancies market. Overall, the deal underscores Gilead\u2019s commitment to long-term growth through high-impact innovation and targeted acquisitions.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-novo-s-cagrisema-fails-to-match-performance-of-eli-lilly-s-zepbound-in-trial\"><span class=\"ez-toc-section\" id=\"Novos_CagriSema_Fails_to_Match_Performance_of_Eli_Lillys_ZEPBOUND_in_Trial\"><\/span>Novo\u2019s CagriSema Fails to Match Performance of Eli Lilly\u2019s ZEPBOUND in Trial<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Novo Nordisk<\/strong> released a major corporate update outlining progress across its metabolic disease portfolio, alongside strategic initiatives aimed at sustaining long-term growth amid intensifying competition in diabetes and obesity care. The announcement highlighted continued strong global demand for <a href=\"https:\/\/www.delveinsight.com\/report-store\/glucagon-like-peptide1-glp1-agonists-market-forecast\">GLP-1\u2013based therapies<\/a>, including treatments for type 2 diabetes and chronic weight management, which remain central to the company\u2019s growth strategy.<\/p>\n\n\n\n<p>The company emphasized advancements in both injectable and oral formulations designed to improve patient adherence and expand access. Novo Nordisk also reiterated its commitment to lifecycle management, investing heavily in next-generation molecules and combination therapies targeting obesity-related comorbidities such as cardiovascular disease, non-alcoholic steatohepatitis (NASH), and chronic kidney disease. Clinical trials across multiple late-stage assets continue to progress, reinforcing the robustness of the pipeline.<\/p>\n\n\n\n<p>At the same time, Novo Nordisk acknowledged operational and market challenges, including capacity constraints, pricing pressures, and rising competition from peers developing alternative incretin-based therapies. In response, the company has undertaken organizational and manufacturing optimization initiatives to enhance supply reliability and cost efficiency. These efforts include investments in new production facilities and selective restructuring to prioritize high-growth therapeutic areas.<\/p>\n\n\n\n<p>From a financial standpoint, Novo Nordisk reaffirmed its long-term outlook, citing sustained revenue growth driven by obesity and diabetes franchises, despite short-term volatility related to investment spending and competitive dynamics. Management underscored that innovation, scale, and deep therapeutic expertise remain key differentiators.<\/p>\n\n\n\n<p>Overall, the update reflects Novo Nordisk\u2019s dual focus on near-term execution and long-term transformation. By strengthening its pipeline, expanding manufacturing capabilities, and sharpening strategic priorities, the company aims to maintain its leadership position in metabolic diseases while navigating a rapidly evolving competitive landscape.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-vanda-pharmaceuticals-receives-fda-approval-of-bysanti-for-bipolar-i-disorder-and-schizophrenia\"><span class=\"ez-toc-section\" id=\"Vanda_Pharmaceuticals_Receives_FDA_Approval_of_BYSANTI_for_Bipolar_I_Disorder_and_Schizophrenia\"><\/span>Vanda Pharmaceuticals Receives FDA Approval of BYSANTI for Bipolar I Disorder and Schizophrenia<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Vanda Pharmaceuticals<\/strong> announced that the U.S. Food and Drug Administration has approved <strong>BYSANTI (milsaperidone)<\/strong> for the treatment of <strong>bipolar I disorder and <\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/schizophrenia-market\"><strong>schizophrenia<\/strong><\/a>, marking a major milestone in psychiatric drug development. Notably, milsaperidone is classified as a new chemical entity, representing a rare instance of novel pharmacological innovation in a therapeutic area that has seen limited breakthroughs over the past decade.<\/p>\n\n\n\n<p>The approval was supported by a comprehensive clinical development program demonstrating efficacy in managing both psychotic and mood symptoms, along with a safety and tolerability profile suitable for long-term use. BYSANTI is designed to address limitations of existing antipsychotic therapies, including metabolic side effects, sedation, and incomplete symptom control, which often lead to poor adherence and suboptimal outcomes.<\/p>\n\n\n\n<p>Vanda emphasized that BYSANTI offers clinicians greater flexibility in treating complex psychiatric conditions that frequently require individualized therapy. The dual indication for bipolar I disorder and schizophrenia broadens its clinical relevance and commercial potential, positioning it as a cornerstone product in Vanda\u2019s neuropsychiatric portfolio.<\/p>\n\n\n\n<p>The company plans a phased commercial launch, supported by targeted physician education and patient access programs. From a strategic perspective, the approval significantly enhances Vanda\u2019s growth outlook, diversifying revenue streams and reinforcing its reputation as an innovator in central nervous system disorders. More broadly, the approval signals renewed momentum in psychiatric drug development, highlighting the continued importance of novel mechanisms of action in addressing unmet mental health needs.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-us-approves-calquence-with-venetoclax-as-the-first-fixed-duration-all-oral-frontline-option-for-cll\"><span class=\"ez-toc-section\" id=\"US_Approves_Calquence_with_Venetoclax_as_the_First_Fixed-duration_All-oral_Frontline_Option_for_CLL\"><\/span>US Approves Calquence with Venetoclax as the First Fixed-duration, All-oral Frontline Option for CLL<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>AstraZeneca <\/strong>announced U.S. approval of a fixed-duration, all-oral combination regimen featuring <strong>Calquence (acalabrutinib)<\/strong> for the treatment of previously untreated chronic lymphocytic leukemia (CLL). This approval represents a significant advancement in CLL care, offering patients an effective alternative to continuous, indefinite therapy.<\/p>\n\n\n\n<p>Calquence, a second-generation <a href=\"https:\/\/www.delveinsight.com\/report-store\/btk-inhibitors-market-forecast\">Bruton&#8217;s tyrosine kinase (BTK) inhibitor<\/a>, has already established a strong clinical profile as a monotherapy. The newly approved combination leverages complementary mechanisms of action to achieve deep and durable responses within a defined treatment period. Clinical trial data demonstrated high rates of progression-free survival and manageable safety, including in patients with high-risk disease features.<\/p>\n\n\n\n<p>The fixed-duration approach is particularly meaningful for patients, as it reduces long-term toxicity, treatment burden, and healthcare costs while preserving efficacy. For AstraZeneca, the approval strengthens its hematology franchise and aligns with broader industry trends favoring time-limited regimens that improve quality of life. Strategically, the decision enhances Calquence\u2019s competitiveness in an increasingly crowded CLL market and reinforces AstraZeneca\u2019s commitment to patient-centric oncology innovation. The company expects rapid adoption in clinical practice, supported by established physician familiarity with Calquence.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-merck-s-enflonsia-exhibits-sustained-efficacy-in-preventing-severe-rsv-in-at-risk-infants-over-two-seasons\"><span class=\"ez-toc-section\" id=\"Mercks_ENFLONSIA_Exhibits_Sustained_Efficacy_in_Preventing_Severe_RSV_in_At-Risk_Infants_Over_Two_Seasons\"><\/span>Merck\u2019s ENFLONSIA Exhibits Sustained Efficacy in Preventing Severe RSV in At-Risk Infants Over Two Seasons<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Merck <\/strong>reported positive new clinical data for <strong>ENFLONSIA (clesrovimab)<\/strong>, an investigational monoclonal antibody being developed to prevent <a href=\"https:\/\/www.delveinsight.com\/report-store\/respiratory-syncytial-virus-rsv-market-size-and-forecast\">respiratory syncytial virus (RSV) disease<\/a> in infants and young children under two years of age who are at increased risk of severe illness. The data, collected across two RSV seasons, demonstrated sustained efficacy and a favorable safety profile.<\/p>\n\n\n\n<p>RSV remains a leading cause of hospitalization in infants worldwide, particularly among premature babies and those with underlying health conditions. ENFLONSIA is designed to provide passive immunity through a single dose, offering season-long protection without the need for repeated administration.<\/p>\n\n\n\n<p>Merck highlighted that clesrovimab could complement existing preventive strategies, including maternal vaccination, and expand options for protecting vulnerable pediatric populations. The consistency of protection across multiple seasons strengthens the case for regulatory submission and potential broad clinical use. From a public health perspective, the data underscore the potential impact of long-acting monoclonal antibodies in reducing RSV-related hospitalizations and healthcare burden. For Merck, ENFLONSIA represents a strategically important asset within its infectious disease portfolio, reinforcing the company\u2019s focus on preventive innovation and pediatric care.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Gilead Sciences Announces Acquisition of Arcellx to Advance Long-Term Growth of Anito-cel Gilead Sciences announced a definitive agreement to acquire Arcellx, a clinical-stage biotechnology company, in a strategic move to strengthen its leadership in cell therapy and oncology innovation. The acquisition builds on an existing collaboration between the two companies focused on anito-cel (anitocabtagene autoleucel), [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":34596,"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":[132,1257,22409,349,639,17615,1519,22172],"industry":[17225],"therapeutic_areas":[17235,17245,17243],"class_list":["post-34595","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-btk-inhibitors","tag-car-t-therapy","tag-glp-1-receptor","tag-latest-pharma-news","tag-pharma-news","tag-respiratory-syncytial-virus","tag-schizophrenia","tag-zepbound","industry-pharmaceutical","therapeutic_areas-cell-and-gene-therapy","therapeutic_areas-neurology","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 | Gilead Sciences, Novo Nordisk, Vanda<\/title>\n<meta name=\"description\" content=\"Gilead Sciences\u2019 Arcellx Acquisition; Novo\u2019s CagriSema; Vanda\u2019s BYSANTI; AstraZeneca\u2019s Calquence; 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-gilead-novo-vanda\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Gilead Sciences, Novo Nordisk, Vanda\" \/>\n<meta property=\"og:description\" content=\"Gilead Sciences\u2019 Arcellx Acquisition; Novo\u2019s CagriSema; Vanda\u2019s BYSANTI; AstraZeneca\u2019s Calquence; Merck\u2019s ENFLONSIA\" 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