{"id":29936,"date":"2024-10-08T14:07:23","date_gmt":"2024-10-08T08:37:23","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=29936"},"modified":"2024-10-08T14:07:24","modified_gmt":"2024-10-08T08:37:24","slug":"pharma-news-for-bms-palvella-orogen","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-bms-palvella-orogen","title":{"rendered":"OPDIVO Approved for Resectable NSCLC; Palvella Gets $2.6M FDA Grant; First Patient Dosed in UGN-103 Bladder Cancer Trial; Recordati Acquires ENJAYMO for $825 Million; AIRSUPRA Reduces Severe Asthma Exacerbations"},"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-69fb958bef97a\" 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-69fb958bef97a\"  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-bms-palvella-orogen\/#FDA_Approves_Perioperative_OPDIVO_Plus_Chemotherapy_for_Resectable_NSCLC\" >FDA Approves Perioperative OPDIVO Plus Chemotherapy for Resectable NSCLC<\/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-bms-palvella-orogen\/#Palvella_Therapeutics_Secures_26M_FDA_Grant_for_Phase_III_Trial_in_Microcystic_Lymphatic_Malformations\" >Palvella Therapeutics Secures $2.6M FDA Grant for Phase III Trial in Microcystic Lymphatic Malformations<\/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-bms-palvella-orogen\/#First_Patient_Dosed_in_Phase_III_UGN-103_Trial_for_Low-Grade_Non-Muscle_Invasive_Bladder_Cancer\" >First Patient Dosed in Phase III UGN-103 Trial for Low-Grade Non-Muscle Invasive Bladder Cancer<\/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-bms-palvella-orogen\/#Italian_Pharma_Company_Recordati_Acquires_ENJAYMO_from_Sanofi_for_825_Million\" >Italian Pharma Company Recordati Acquires ENJAYMO from Sanofi for $825 Million<\/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-bms-palvella-orogen\/#AIRSUPRA_Shows_Significant_Reduction_in_Severe_Asthma_Exacerbations_in_BATURA_Phase_III_Trial\" >AIRSUPRA Shows Significant Reduction in Severe Asthma Exacerbations in BATURA Phase III Trial<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-approves-perioperative-opdivo-plus-chemotherapy-for-resectable-nsclc\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Perioperative_OPDIVO_Plus_Chemotherapy_for_Resectable_NSCLC\"><\/span>FDA Approves Perioperative OPDIVO Plus Chemotherapy for Resectable NSCLC<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The FDA has granted approval to Bristol Myers Squibb\u2019s OPDIVO (nivolumab) for the treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/non-small-cell-lung-cancer-nsclc-market\">adult patients with resectable non-small cell lung cancer (NSCLC)<\/a>, specifically targeting tumors that are 4 cm or larger or node-positive and have no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. The new regimen combines neoadjuvant OPDIVO with platinum-doublet chemotherapy, followed by single-agent OPDIVO as an adjuvant treatment after surgery. This innovative approach, known as perioperative therapy, aims to improve outcomes for patients undergoing surgical intervention.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Dr. Tina Cascone, an associate professor at The University of Texas MD Anderson Cancer Center, emphasized the significance of this approval, stating, \u201cGiven the rates of disease recurrence in patients with resectable NSCLC, there is a clear need for options that can be administered before and after surgery. This regimen not only targets micrometastasis but also helps reduce the risk of cancer returning, potentially improving the chance of successful surgical treatment.\u201d The CheckMate-77T trial, which led to this approval, revealed that the OPDIVO arm significantly improved event-free survival (EFS) compared to the chemotherapy and placebo arm, with a notable 42% reduction in the risk of disease recurrence or progression.<\/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>Results from the trial indicated that 70% of patients in the OPDIVO arm achieved 18-month EFS, in contrast to just 50% in the comparator arm. Moreover, 25% of patients receiving OPDIVO achieved a pathologic complete response (pCR), compared to only 4.7% in the control group. &#8220;With this new OPDIVO-based regimen, we are reinforcing our commitment to improving patient outcomes and expanding our thoracic portfolio in early-stage disease,&#8221; stated Wendy Short Bartie, senior vice president of U.S. Oncology and Hematology at Bristol Myers Squibb.<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>OPDIVO is associated with several warnings, including severe immune-mediated adverse reactions, and is not recommended for certain patient combinations outside of clinical trials. The recommended dosage includes 360 mg of OPDIVO combined with platinum-doublet chemotherapy every three weeks for up to four cycles, followed by 480 mg of single-agent OPDIVO every four weeks for up to a year or until disease recurrence or unacceptable toxicity occurs. This approval builds on previous successes of OPDIVO in various cancer treatments, reinforcing its role in neoadjuvant, adjuvant, and perioperative settings across multiple cancers, including <a href=\"https:\/\/www.delveinsight.com\/report-store\/melanoma-market\">melanoma<\/a> and <a href=\"https:\/\/www.delveinsight.com\/report-store\/bladder-cancer-market\">bladder cancer<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-palvella-therapeutics-secures-2-6m-fda-grant-for-phase-iii-trial-in-microcystic-lymphatic-malformations\"><span class=\"ez-toc-section\" id=\"Palvella_Therapeutics_Secures_26M_FDA_Grant_for_Phase_III_Trial_in_Microcystic_Lymphatic_Malformations\"><\/span>Palvella Therapeutics Secures $2.6M FDA Grant for Phase III Trial in Microcystic Lymphatic Malformations<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Palvella Therapeutics, Inc. has announced that it has received a significant grant of up to $2.6 million from the FDA Office of Orphan Products Development to support its ongoing Phase III SELVA trial. This trial focuses on QTORIN 3.9% rapamycin anhydrous gel, which is being investigated for <a href=\"https:\/\/www.delveinsight.com\/report-store\/lymphatic-malformations-market\">treating microcystic lymphatic malformation<\/a>. The funding highlights the urgent need for effective therapies for patients suffering from this serious and rare genetic skin disease, for which there are currently no FDA-approved treatments.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Wes Kaupinen, Founder and Chief Executive Officer of Palvella, expressed enthusiasm about the grant, stating, \u201cWe believe this grant underscores the high unmet medical need in this serious, rare, and chronically debilitating genetic disease, the scientific rationale for targeted inhibition of the causative PI3K\/mTOR pathway, and QTORIN rapamycin\u2019s potential to be the first approved therapy and standard of care in the U.S. for microcystic LMs.\u201d The FDA&#8217;s Orphan Products Grants Program received 51 grant applications in fiscal year 2024, with Palvella&#8217;s trial being one of only seven selected for funding, reflecting the program\u2019s commitment to supporting innovative treatments for rare diseases.<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The FDA Orphan Products Grants Program aims to foster the development of safe and effective medical products for rare conditions by awarding grants based on scientific and technical merit, as evaluated by an independent panel of experts. Historically, these grants have contributed to approving over 85 products since the program&#8217;s inception. The ongoing Phase III trial for QTORIN\u2122 rapamycin is notable for receiving both Breakthrough Therapy Designation and Fast Track Designation from the FDA, emphasizing its potential to address significant unmet medical needs in treating microcystic lymphatic malformations.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-first-patient-dosed-in-phase-iii-ugn-103-trial-for-low-grade-non-muscle-invasive-bladder-cancer\"><span class=\"ez-toc-section\" id=\"First_Patient_Dosed_in_Phase_III_UGN-103_Trial_for_Low-Grade_Non-Muscle_Invasive_Bladder_Cancer\"><\/span>First Patient Dosed in Phase III UGN-103 Trial for Low-Grade Non-Muscle Invasive Bladder Cancer<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>UroGen Pharma Ltd. has officially announced the dosing of the first patient in its Phase III clinical trial for UGN-103, an investigational intravesical solution designed to <a href=\"https:\/\/www.delveinsight.com\/report-store\/non-muscle-invasive-bladder-cancer-market\">treat low-grade intermediate-risk non-muscle invasive bladder cancer<\/a>. This next-generation formulation of mitomycin represents a significant advancement in bladder cancer treatment and is designed to streamline the manufacturing process and simplify the reconstitution procedure for healthcare providers.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>Liz Barrett, President and Chief Executive Officer of UroGen, remarked, \u201cReaching this Phase III trial milestone for UGN-103 highlights our drive to innovate and bring forward cutting-edge treatments for low-grade intermediate-risk non-muscle invasive bladder cancer. UGN-103 represents a significant step forward, offering potential improvements in manufacturing, convenience, and cost.\u201d The drug utilizes UroGen\u2019s proprietary RTGel\u00ae platform technology, which is a sustained-release hydrogel that aims to enhance the therapeutic profile of existing drugs.<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The FDA accepted the Investigational New Drug Application for UGN-103 in April 2024, allowing its investigational use in adults with this highly recurrent form of bladder cancer. Following the anticipated FDA approval of UGN-102, UroGen is poised to advance UGN-103, which is set to undergo evaluation in the UTOPIA study. This single-arm, multicenter study aims to enroll 87 patients, who will receive 75 mg of UGN-103 weekly for six weeks. Efficacy will be measured through the complete response rate at the three-month follow-up, with participants monitored until disease recurrence or progression, ensuring ongoing evaluation of UGN-103\u2019s effectiveness in managing LG-IR-NMIBC.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-italian-pharma-company-recordati-acquires-enjaymo-from-sanofi-for-825-million\"><span class=\"ez-toc-section\" id=\"Italian_Pharma_Company_Recordati_Acquires_ENJAYMO_from_Sanofi_for_825_Million\"><\/span>Italian Pharma Company Recordati Acquires ENJAYMO from Sanofi for $825 Million<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Recordati S.p.A., an Italian pharmaceutical company, has announced a major acquisition. It has secured the global rights to ENJAYMO (sutimlimab) from Sanofi SA for an upfront payment of $825 million, along with additional commercial milestone payments that could reach up to $250 million. ENJAYMO, a humanized monoclonal antibody approved by the FDA in 2022, is currently the<a href=\"https:\/\/www.delveinsight.com\/report-store\/cold-agglutinin-disease-cad-market\"> only targeted treatment for cold agglutinin disease (CAD)<\/a>, a rare autoimmune disorder characterized by the premature destruction of red blood cells.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;Acquiring ENJAYMO allows us to expand our rare diseases portfolio in the U.S., Japan, and Europe,&#8221; said Recordati CEO Rob Koremans. He added, \u201cThis acquisition not only addresses a significant unmet medical need for patients suffering from CAD but is also expected to positively impact our top and bottom lines.\u201d The deal, anticipated to close by the end of 2024, is expected to have minimal revenue contribution in 2024, but Recordati projects a substantial revenue increase in fiscal 2025, with estimates exceeding 150 million euros.<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>ENJAYMO generated approximately \u20ac100 million ($109.7 million) in revenue over the last year and is projected to achieve peak sales potential of \u20ac250 million to \u20ac300 million. The acquisition will be funded through existing cash and new bank debt, with Recordati maintaining that its capital allocation and dividend policies will remain unaffected. The deal follows Sanofi&#8217;s recent strategic moves, including a $27 million investment in Ventyx Biosciences, signaling a shift in focus under CEO Paul Hudson.<\/p>\n\n\n\n<p>As CAD affects about 11,000 patients in the U.S., Japan, and Europe, ENJAYMO works by selectively targeting the C1 complement protein, effectively blocking the complement-mediated destruction of red blood cells. Although sales for ENJAYMO have seen significant growth, with nearly $80 million in revenue generated in 2023 and a 73% increase in the first half of 2024, the decision to sell reflects Sanofi&#8217;s broader strategy to regain investor confidence amid operational challenges.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-airsupra-shows-significant-reduction-in-severe-asthma-exacerbations-in-batura-phase-iii-trial\"><span class=\"ez-toc-section\" id=\"AIRSUPRA_Shows_Significant_Reduction_in_Severe_Asthma_Exacerbations_in_BATURA_Phase_III_Trial\"><\/span>AIRSUPRA Shows Significant Reduction in Severe Asthma Exacerbations in BATURA Phase III Trial<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Asthma treatment took a major leap forward with AstraZeneca\u2019s AIRSUPRA (albuterol\/budesonide) demonstrating significant efficacy in reducing severe exacerbations in the BATURA Phase IIIb trial. The trial, which focused on <a href=\"https:\/\/www.delveinsight.com\/report-store\/asthma-market\">patients with intermittent or mild persistent asthma<\/a>, showed that AIRSUPRA, when used as an as-needed rescue medication, led to a statistically significant and clinically meaningful reduction in severe asthma exacerbations compared to albuterol alone. Due to the overwhelming efficacy, the Independent Data Monitoring Committee recommended stopping the trial early, marking a breakthrough in the management of mild asthma, a condition that affects millions globally.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>James Donohue, Chair of the Independent Data Monitoring Committee, noted, &#8220;People with asthma are at risk of severe exacerbations regardless of their disease severity. The BATURA trial results showcase the benefits of an anti-inflammatory rescue approach that tackles both symptoms and inflammation simultaneously.&#8221; Sharon Barr, Executive Vice-President of BioPharmaceuticals R&amp;D at AstraZeneca, added, &#8220;These results solidify AIRSUPRA&#8217;s role as a first-in-class treatment, helping to reduce the risk of asthma exacerbations and the need for systemic corticosteroids.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>AIRSUPRA is already approved in the US for adults and is being studied in adolescents and other global regions. Its safety profile in the BATURA trial remained consistent with previous studies, and full data will be presented at the upcoming American College of Allergy, Asthma &amp; Immunology (ACAAI) Annual Scientific Meeting.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA Approves Perioperative OPDIVO Plus Chemotherapy for Resectable NSCLC The FDA has granted approval to Bristol Myers Squibb\u2019s OPDIVO (nivolumab) for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC), specifically targeting tumors that are 4 cm or larger or node-positive and have no known epidermal growth factor receptor (EGFR) mutations or [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":29937,"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":[1875,21560,349,420,20061,16712,16711,1111,12558,431,639,5789],"industry":[17225],"therapeutic_areas":[17228,17243],"class_list":["post-29936","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-asthma","tag-cold-agglutinin-disease","tag-latest-pharma-news","tag-news","tag-nmibc","tag-nmibc-market","tag-non-muscle-invasive-bladder-cancer","tag-nsclc","tag-nsclc-market","tag-opdivo","tag-pharma-news","tag-recent-pharma-news","industry-pharmaceutical","therapeutic_areas-oncology","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 | BMS, Palvella, UroGen<\/title>\n<meta name=\"description\" content=\"BMS\u2019 OPDIVO Approval, Palvella\u2019s $2.6M Grant, UGgN-103 Trial Dosing, Recordati Buys ENJAYMO, AstraZeneca\u2019s AIRSUPRA\" \/>\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-bms-palvella-orogen\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | BMS, Palvella, UroGen\" \/>\n<meta property=\"og:description\" content=\"BMS\u2019 OPDIVO Approval, Palvella\u2019s $2.6M Grant, UGgN-103 Trial Dosing, Recordati Buys ENJAYMO, AstraZeneca\u2019s AIRSUPRA\" \/>\n<meta property=\"og:url\" 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