{"id":33400,"date":"2025-09-16T16:40:30","date_gmt":"2025-09-16T11:10:30","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=33400"},"modified":"2025-09-16T16:41:08","modified_gmt":"2025-09-16T11:11:08","slug":"pharma-news-for-corstasis-amneal-greenwich","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-corstasis-amneal-greenwich","title":{"rendered":"Lion TCR Secures Triple FDA Milestones with IND Clearance for Chronic Hepatitis B; Corstasis Therapeutics Wins FDA Approval for ENBUMYST Nasal Spray to Treat Edema in CHF, Liver, and Kidney Disease; Amneal Gains FDA Approval for Sodium Oxybate Oral Solution in Narcolepsy Patients with Cataplexy and Excessive Daytime Sleepiness; Greenwich LifeSciences\u2019 GLSI-100 Granted FDA Fast Track Designation; Akeso\u2019s Ligufalimab Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia"},"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-69f3039473bfe\" 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-69f3039473bfe\"  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-corstasis-amneal-greenwich\/#Lion_TCR_Secures_Triple_FDA_Milestones_for_Chronic_Hepatitis_B_with_IND_Clearance_of_TCR-T_Therapy\" >Lion TCR Secures Triple FDA Milestones for Chronic Hepatitis B with IND Clearance of TCR-T Therapy<\/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-corstasis-amneal-greenwich\/#Corstasis_Therapeutics_Wins_FDA_Approval_for_ENBUMYST%E2%84%A2_Nasal_Spray_to_Treat_Edema_in_CHF_Liver_and_Kidney_Disease\" >Corstasis Therapeutics Wins FDA Approval for ENBUMYST\u2122 Nasal Spray to Treat Edema in CHF, Liver, and Kidney Disease<\/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-corstasis-amneal-greenwich\/#Amneal_Gains_FDA_Approval_for_Sodium_Oxybate_Oral_Solution_in_Narcolepsy_Patients_with_Cataplexy_and_Excessive_Daytime_Sleepiness\" >Amneal Gains FDA Approval for Sodium Oxybate Oral Solution in Narcolepsy Patients with Cataplexy and Excessive Daytime Sleepiness<\/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-corstasis-amneal-greenwich\/#Greenwich_LifeSciences_GLSI-100_Granted_FDA_Fast_Track_Designation_for_HER2-positive_Breast_Cancer\" >Greenwich LifeSciences\u2019 GLSI-100 Granted FDA Fast Track Designation for HER2-positive Breast 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-corstasis-amneal-greenwich\/#Akesos_Ligufalimab_Granted_FDA_Orphan_Drug_Designation_for_Acute_Myeloid_Leukemia\" >Akeso\u2019s Ligufalimab Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-lion-tcr-secures-triple-fda-milestones-for-chronic-hepatitis-b-with-ind-clearance-of-tcr-t-therapy\"><span class=\"ez-toc-section\" id=\"Lion_TCR_Secures_Triple_FDA_Milestones_for_Chronic_Hepatitis_B_with_IND_Clearance_of_TCR-T_Therapy\"><\/span>Lion TCR Secures Triple FDA Milestones for Chronic Hepatitis B with IND Clearance of TCR-T Therapy<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Lion TCR announced that the FDA has cleared its Investigational New Drug (IND) application for <strong>LioCyx-M004<\/strong>, authorizing the initiation of phase Ib\/II clinical trials in patients with chronic hepatitis B (CHB). The clearance marks the <strong>third major regulatory milestone<\/strong> for the candidate, which had earlier received both <strong>Fast Track<\/strong> and <strong>Orphan Drug Designations<\/strong> for <a href=\"https:\/\/www.delveinsight.com\/report-store\/hepatocellular-carcinoma-market\">hepatitis B virus-related hepatocellular carcinoma (HBV-HCC)<\/a>.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis triple recognition from the FDA underscores the transformative potential of LioCyx-M004 and validates our strategy of targeting HBV-associated diseases with TCR-T therapies,\u201d said <\/em><strong><em>Dr. Xiaoming Peng, CEO of Lion TCR<\/em><\/strong><em>. \u201cWe are now well-positioned to evaluate its potential impact on the underlying viral infection that drives cancer development.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Developed as an autologous TCR-T cell therapy, LioCyx-M004 leverages mRNA technology to encode T-cell receptors that specifically recognize HBV antigens. Preclinical and early studies demonstrated its ability to reduce viral antigen load while maintaining a favorable safety profile. The therapy represents the first TCR-T candidate to enter clinical development for <a href=\"https:\/\/www.delveinsight.com\/report-store\/chronic-hepatitis-b-virus-market\">Chronic Hepatitis B<\/a>, a condition that affects more than 290 million people globally.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cOur ability to successfully redirect our lead candidate from oncology to virology highlights the versatility of our platform,\u201d added <\/em><strong><em>Dr. Tina Wang, Chief Medical Officer of Lion TCR<\/em><\/strong><em>. \u201cWith this IND clearance, we are one step closer to exploring LioCyx-M004\u2019s potential as a functional cure for CHB.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>The company is also advancing its AI-powered TCR discovery platform and an in vivo TCR-T therapy program, validated by leading U.S. research institutes, with plans to expand into additional solid tumor indications such as lung, breast, and gastrointestinal cancers.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-corstasis-therapeutics-wins-fda-approval-for-enbumyst-nasal-spray-to-treat-edema-in-chf-liver-and-kidney-disease\"><span class=\"ez-toc-section\" id=\"Corstasis_Therapeutics_Wins_FDA_Approval_for_ENBUMYST%E2%84%A2_Nasal_Spray_to_Treat_Edema_in_CHF_Liver_and_Kidney_Disease\"><\/span>Corstasis Therapeutics Wins FDA Approval for ENBUMYST\u2122 Nasal Spray to Treat Edema in CHF, Liver, and Kidney Disease<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Corstasis Therapeutics Inc.<\/strong> announced that the FDA has approved <strong>ENBUMYST (bumetanide nasal spray) <\/strong>for the treatment of edema associated with <a href=\"https:\/\/www.delveinsight.com\/report-store\/congestive-heart-failure-market\"><strong>congestive heart failure (CHF)<\/strong><\/a>, hepatic disease, and renal disease, including <a href=\"https:\/\/www.delveinsight.com\/report-store\/nephrotic-syndrome-market\">nephrotic syndrome<\/a> in adults. The therapy is positioned as the first self-administered outpatient alternative, bridging the gap between oral loop diuretics and intravenous (IV) therapy.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe FDA approval of ENBUMYST represents a meaningful advancement in the treatment of edema for patients and providers,\u201d <\/em><strong><em>said Ben Esque, Chief Executive Officer of Corstasis Therapeutics<\/em><\/strong><em>. \u201cThis new option can help improve access to care while addressing critical limitations of current therapies.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>In clinical studies, ENBUMYST demonstrated rapid absorption and a predictable diuretic effect, showing comparable efficacy to IV bumetanide injection. Traditional oral loop diuretics are often limited by poor gastrointestinal absorption, while IV therapies require hospital-based care. By offering a convenient nasal spray, ENBUMYST has the potential to reduce costly hospitalizations and readmissions, which remain a leading driver of healthcare spending in CHF and chronic kidney disease.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cENBUMYST was designed in direct collaboration with cardiologists to address practical challenges in outpatient care,\u201d added <\/em><strong><em>Dr. Brian Kolski, Chief Medical Director of Corstasis<\/em><\/strong><em>. \u201cIts ability to be administered outside of the hospital could change the standard of care for managing fluid overload.\u201d Corstasis expects to launch ENBUMYST in the U.S. in Q4 2025, with a commercial focus on cardiologists, nephrologists, hepatologists, and outpatient heart failure clinics.<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-amneal-gains-fda-approval-for-sodium-oxybate-oral-solution-in-narcolepsy-patients-with-cataplexy-and-excessive-daytime-sleepiness\"><span class=\"ez-toc-section\" id=\"Amneal_Gains_FDA_Approval_for_Sodium_Oxybate_Oral_Solution_in_Narcolepsy_Patients_with_Cataplexy_and_Excessive_Daytime_Sleepiness\"><\/span>Amneal Gains FDA Approval for Sodium Oxybate Oral Solution in Narcolepsy Patients with Cataplexy and Excessive Daytime Sleepiness<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Amneal Pharmaceuticals, Inc. (\u201cAmneal\u201d or the \u201cCompany\u201d) <\/strong>announced that the FDA has approved its sodium oxybate oral solution 500 mg\/mL Abbreviated New Drug Application (ANDA), referencing<strong> Jazz Pharmaceuticals\u2019 XYREM.<\/strong> The approval follows Amneal\u2019s prior distribution of an authorized generic of sodium oxybate in limited quantities.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThis approval expands Amneal\u2019s Affordable Medicines portfolio into a critical therapy area for patients living with narcolepsy, a rare neurological condition affecting approximately 150,000 individuals in the U.S.,\u201d said <\/em><strong><em>Tony Rosa, Senior Vice President, Retail Affordable Medicines<\/em><\/strong><em>. \u201cBy offering sodium oxybate, Amneal is providing patients, providers, and payers with a more affordable alternative in a category historically limited to a single manufacturer.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Sodium oxybate is a central nervous system depressant indicated for the treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/cataplexy-market\">cataplexy<\/a> and <a href=\"https:\/\/www.delveinsight.com\/report-store\/excessive-daytime-sleepiness-eds-market\">excessive daytime sleepiness (EDS)<\/a> in patients with <a href=\"https:\/\/www.delveinsight.com\/report-store\/narcolepsy-market\">narcolepsy<\/a>. It is considered a standard-of-care therapy due to its ability to consolidate nighttime sleep and significantly reduce cataplexy episodes. Common adverse reactions in adults include nausea, dizziness, vomiting, somnolence, enuresis, and tremor, while pediatric patients may experience nausea, enuresis, vomiting, headache, decreased appetite, weight loss, dizziness, and sleepwalking.<\/p>\n\n\n\n<p>The FDA approval positions Amneal to broaden access to this critical therapy, offering a safe and effective treatment option for patients with narcolepsy while supporting affordability and patient choice in a previously limited market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-greenwich-lifesciences-glsi-100-granted-fda-fast-track-designation-for-her2-positive-breast-cancer\"><span class=\"ez-toc-section\" id=\"Greenwich_LifeSciences_GLSI-100_Granted_FDA_Fast_Track_Designation_for_HER2-positive_Breast_Cancer\"><\/span>Greenwich LifeSciences\u2019 GLSI-100 Granted FDA Fast Track Designation for HER2-positive Breast Cancer<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Greenwich LifeSciences, Inc.<\/strong>, a clinical-stage biopharmaceutical company, announced that the FDA has granted Fast Track designation for <strong>GLSI-100<\/strong> in patients with HLA-A*02 genotype and <a href=\"https:\/\/www.delveinsight.com\/report-store\/her2-positive-breast-cancer-market\">HER2-positive breast cancer<\/a> following standard HER2\/neu-targeted therapy. The designation may allow for more frequent interactions with the FDA and the potential use of a rolling Biologic License Application (BLA) review process.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><strong><em>Dr. Jaye Thompson,<\/em><\/strong><em> VP Clinical and Regulatory Affairs, commented, &#8220;Greenwich is pleased that the FDA sees the potential of GLSI-100 to change important clinical outcomes in this population of breast cancer patients. We continue to work earnestly to collect data to support a BLA filing demonstrating this benefit.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>GLSI-100 is being evaluated in the company\u2019s Phase III clinical trial, FLAMINGO-01, which is focused on preventing breast cancer recurrence. The Fast Track designation recognizes the therapy\u2019s potential to improve invasive breast cancer-free survival and address an unmet medical need.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><strong><em>CEO Snehal Patel <\/em><\/strong><em>added, &#8220;We are excited to have received Fast Track designation. The FDA review included an assessment of GLSI-100\u2019s potential to prevent metastatic breast cancer recurrence in the patient population we are studying. We plan to continue discussions with the FDA and explore additional ways to make GLSI-100 available to larger populations.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-akeso-s-ligufalimab-granted-fda-orphan-drug-designation-for-acute-myeloid-leukemia\"><span class=\"ez-toc-section\" id=\"Akesos_Ligufalimab_Granted_FDA_Orphan_Drug_Designation_for_Acute_Myeloid_Leukemia\"><\/span>Akeso\u2019s Ligufalimab Granted FDA Orphan Drug Designation for Acute Myeloid Leukemia<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Akeso Inc. (9926.HK)<\/strong> announced that its next-generation humanized IgG4 monoclonal antibody targeting CD47,<strong> ligufalimab (AK117)<\/strong>, has been granted Orphan Drug Designation (ODD) by the FDA for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/acute-myeloid-leukemia-aml-market\">treatment of acute myeloid leukemia (AML)<\/a>. The designation provides comprehensive FDA guidance, tax incentives, and up to seven years of market exclusivity upon approval.<\/p>\n\n\n\n<p>Ligufalimab is currently under international clinical development for both hematologic malignancies and solid tumors. Patient enrollment has completed in a randomized, double-blind, multicenter phase II study evaluating ligufalimab combined with azacitidine in higher-risk myelodysplastic syndromes (HR-MDS). Additionally, ligufalimab is the first CD47 monoclonal antibody to enter registrational phase III trials in solid tumors, including PD-L1-positive head and neck squamous cell carcinoma (HNSCC) and pancreatic cancer.<\/p>\n\n\n\n<p>AML is a heterogeneous hematologic malignancy and the most common acute leukemia in adults. Existing treatments for patients ineligible for intensive chemotherapy are limited, with more than half relapsing within 6\u20139 months despite therapies such as venetoclax in combination with azacitidine. Ligufalimab\u2019s mechanism blocks CD47 on tumor cells, enhancing macrophage-mediated phagocytosis and inhibiting tumor growth while preventing red blood cell agglutination.<\/p>\n\n\n\n<p>Preclinical and clinical studies show that ligufalimab, alone or combined with azacitidine or venetoclax, enhances \u201c<strong>eat me<\/strong>\u201d signals, promoting efficient immune response. In first-line AML patients, the phase II study demonstrated favorable safety and promising efficacy, with complete remission (CR) rates reaching 50% and composite CR (cCR) rates of 55% at the target dose of 45 mg\/kg administered biweekly.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Lion TCR Secures Triple FDA Milestones for Chronic Hepatitis B with IND Clearance of TCR-T Therapy Lion TCR announced that the FDA has cleared its Investigational New Drug (IND) application for LioCyx-M004, authorizing the initiation of phase Ib\/II clinical trials in patients with chronic hepatitis B (CHB). The clearance marks the third major regulatory milestone [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":33402,"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":[18089,59,22442,22441,2844,16821,16827,183,20521,204,17502,704,1964,5384,5996,5998,20589,1694,349,828,22664,5803,21891,420,639],"industry":[17225],"therapeutic_areas":[17242,17240,17231,17245,17228],"class_list":["post-33400","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-acute-myeloid-leukemia","tag-acute-myeloid-leukemia-aml","tag-acute-myeloid-leukemia-market","tag-acute-myeloid-leukemia-treatment","tag-cataplexy","tag-chronic-hepatitis-b-market","tag-chronic-hepatitis-b-treatment","tag-congestive-heart-failure","tag-congestive-heart-failure-chf-treatment","tag-delveinsight","tag-excessive-daytime-sleepiness","tag-fda","tag-hepatitis-b","tag-hepatitis-b-market","tag-hepatocellular-carcinoma","tag-hepatocellular-carcinoma-therapies","tag-her2-positive-breast-cancer-treatment","tag-her2-positive-breast-cancer","tag-latest-pharma-news","tag-narcolepsy","tag-narcolepsy-market","tag-narcolepsy-treatment","tag-nephrotic-syndrome","tag-news","tag-pharma-news","industry-pharmaceutical","therapeutic_areas-cardiovascular-diseases","therapeutic_areas-endocrinology-and-metabolic-disorders","therapeutic_areas-infectious-diseases","therapeutic_areas-neurology","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 | Corstasis, Amneal, Greenwich<\/title>\n<meta name=\"description\" content=\"Lion TCR\u2019s TCR-T Therapy; Corstasis\u2019 ENBUMYST; Amneal\u2019s Sodium Oxybate; Greenwich\u2019s GLSI-100; Akeso\u2019s Ligufalimab\" \/>\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-corstasis-amneal-greenwich\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Corstasis, Amneal, Greenwich\" \/>\n<meta property=\"og:description\" content=\"Lion TCR\u2019s TCR-T Therapy; Corstasis\u2019 ENBUMYST; Amneal\u2019s Sodium Oxybate; Greenwich\u2019s GLSI-100; Akeso\u2019s Ligufalimab\" \/>\n<meta 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