{"id":31480,"date":"2025-04-15T17:45:00","date_gmt":"2025-04-15T12:15:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=31480"},"modified":"2025-04-16T10:27:11","modified_gmt":"2025-04-16T04:57:11","slug":"pharma-news-for-cellenkos-mirum-soleno","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-cellenkos-mirum-soleno","title":{"rendered":"Cellenkos\u2019 CK0801 Granted FDA Orphan Drug Status for Aplastic Anemia; Mirum\u2019s LIVMARLI Gets FDA Nod for Tablet Formulation; SynOx\u2019s Emactuzumab Earns FDA Fast Track for TGCT; Bristol Myers Squibb\u2019s OPDIVO + YERVOY Combo Approved by FDA for First-Line Advanced Liver Cancer; Soleno Launches VYKAT XR, the First FDA-Approved Therapy for PWS-Related Hyperphagia"},"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-69f02f3f82ad3\" 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-69f02f3f82ad3\"  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-cellenkos-mirum-soleno\/#Cellenkos_CK0801_Granted_FDA_Orphan_Drug_Designation_for_Aplastic_Anemia\" >Cellenkos\u2019 CK0801 Granted FDA Orphan Drug Designation for Aplastic Anemia<\/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-cellenkos-mirum-soleno\/#Mirums_LIVMARLI_Gets_FDA_Nod_for_New_Tablet_Formulation\" >Mirum\u2019s LIVMARLI Gets FDA Nod for New Tablet Formulation<\/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-cellenkos-mirum-soleno\/#SynOxs_Emactuzumab_Receives_FDA_Fast_Track_for_Tenosynovial_Giant_Cell_Tumor\" >SynOx\u2019s Emactuzumab Receives FDA Fast Track for Tenosynovial Giant Cell Tumor<\/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-cellenkos-mirum-soleno\/#Bristol_Myers_Squibbs_OPDIVO_YERVOY_Combo_Gets_FDA_Approval_for_First-Line_Treatment_of_Advanced_Liver_Cancer\" >Bristol Myers Squibb\u2019s OPDIVO + YERVOY Combo Gets FDA Approval for First-Line Treatment of Advanced Liver 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-cellenkos-mirum-soleno\/#Soleno_Launches_VYKAT_XR_The_First_Approved_Therapy_for_PWS-Related_Hyperphagia\" >Soleno Launches VYKAT XR, The First Approved Therapy for PWS-Related Hyperphagia<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-cellenkos-ck0801-granted-fda-orphan-drug-designation-for-aplastic-anemia\"><span class=\"ez-toc-section\" id=\"Cellenkos_CK0801_Granted_FDA_Orphan_Drug_Designation_for_Aplastic_Anemia\"><\/span>Cellenkos\u2019 CK0801 Granted FDA Orphan Drug Designation for Aplastic Anemia<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Cellenkos\u00ae Inc.<\/strong> announced that the <strong>FDA <\/strong>has granted <strong>Orphan Drug Designation to CK0801, <\/strong>its off-the-shelf, <strong>allogeneic T regulatory (Treg) cell therapy, <\/strong>for the treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/aplastic-anemia-market\"><strong>Aplastic Anemia<\/strong><\/a>\u2014a rare and life-threatening bone marrow failure disorder affecting fewer than 200,000 individuals in the U.S. The designation provides Cellenkos with regulatory and financial incentives, including potential seven-year market exclusivity upon approval. Aplastic Anemia has a projected U.S. prevalence of about 5,000 patients.<\/p>\n\n\n\n<p>Encouraging data from a Phase I trial (NCT03773393), published in <em>NEJM Evidence<\/em>, showed CK0801 to be safe and effective, with two of three transfusion-dependent patients achieving complete transfusion independence lasting up to 3.5 years. The trial also demonstrated a 67% overall response rate and no serious adverse events, highlighting CK0801\u2019s strong safety profile and its unique non-immunosuppressive mechanism of action.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;Receiving Orphan Drug Designation for CK0801 in Aplastic Anemia underscores the importance of bringing novel, transformative treatment options to patients suffering from this rare disease,&#8221; said Dr. Simrit Parmar, MD, Founder of Cellenkos. Dr. Parmar is also faculty at The College of Medicine at Texas A&amp;M University. &#8220;We aim to deliver a transformative therapeutic that can reduce the burden of blood and platelet transfusions in patients with Aplastic Anemia who have failed to respond to standard-of-care treatment.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Beyond Aplastic Anemia, CK0801 has also shown promise in other bone marrow failure syndromes such as Myelofibrosis and Myelodysplastic Syndromes. Patients in the study experienced symptom relief, transfusion independence, and even complete remission in one case post-stem cell transplant. Cellenkos is now advancing CK0801 toward a registration trial to support regulatory approval.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-mirum-s-livmarli-gets-fda-nod-for-new-tablet-formulation\"><span class=\"ez-toc-section\" id=\"Mirums_LIVMARLI_Gets_FDA_Nod_for_New_Tablet_Formulation\"><\/span>Mirum\u2019s LIVMARLI Gets FDA Nod for New Tablet Formulation<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Mirum Pharmaceuticals, Inc.<\/strong> announced that the <strong>FDA <\/strong>has approved a new tablet formulation of <strong>LIVMARLI (maralixibat)<\/strong> for the treatment of <strong>cholestatic pruritus<\/strong> in patients with <a href=\"https:\/\/www.delveinsight.com\/report-store\/alagille-syndrome-market\"><strong>Alagille syndrome (ALGS)<\/strong><\/a> and <a href=\"https:\/\/www.delveinsight.com\/report-store\/progressive-familial-intrahepatic-cholestasis-pfic-market\"><strong>Progressive Familial Intrahepatic Cholestasis (PFIC)<\/strong><\/a>. LIVMARLI tablets are expected to be available in June through Mirum Access Plus.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe approval of LIVMARLI in tablet form provides a meaningful additional treatment option for patients with ALGS and PFIC. It allows flexibility for patients and physicians, with the liquid dosing used by the youngest patients and a convenient one-tablet per dose option for older patients,\u201d said Peter Radovich, president and chief operating officer at Mirum.<\/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>\u201cWe have had tremendous success with LIVMARLI since its launch, and we hope that the availability of the tablet will provide convenience that positively impacts patients\u2019 lives,\u201d he added.<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>LIVMARLI (maralixibat) is an orally administered ileal bile acid transporter (IBAT) inhibitor approved for two pediatric cholestatic liver diseases, both in liquid and tablet formulations. It is approved for the treatment of cholestatic pruritus in patients with ALGS in the U.S. from three months of age and older, and for PFIC in patients 12 months of age and older. LIVMARLI is also being evaluated in the Phase III EXPAND study in additional settings of cholestatic pruritus. For more information on ongoing clinical trials, visit Mirum&#8217;s clinical trials section on their website.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-synox-s-emactuzumab-receives-fda-fast-track-for-tenosynovial-giant-cell-tumor\"><span class=\"ez-toc-section\" id=\"SynOxs_Emactuzumab_Receives_FDA_Fast_Track_for_Tenosynovial_Giant_Cell_Tumor\"><\/span>SynOx\u2019s Emactuzumab Receives FDA Fast Track for Tenosynovial Giant Cell Tumor<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>SynOx Therapeutics<\/strong> has received <strong>Fast Track Designation (FTD)<\/strong> from the <strong>FDA <\/strong>for <strong>emactuzumab <\/strong>in the treatment of <a href=\"https:\/\/www.delveinsight.com\/report-store\/tenosynovial-giant-cell-tumors-tsgcts-market\"><strong>Tenosynovial Giant Cell Tumours (TGCT)<\/strong><\/a><strong> <\/strong>in patients who are not suitable for surgery or unlikely to benefit from it. Emactuzumab is a CSF-1 receptor (CSF-1R) inhibiting monoclonal antibody, currently being evaluated in the global Phase III TANGENT trial.<\/p>\n\n\n\n<p>TGCT is a rare, non-cancerous but aggressive joint tumor that causes joint dysfunction, pain, and reduced mobility, primarily in the knees, hips, and ankles. The FTD status was supported by earlier Phase I\/II data showing rapid and durable tumor reduction with a manageable safety profile. Emactuzumab has also been designated as an Orphan Medicinal Product by the EMA.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe granting of FTD for emactuzumab in TGCT highlights the devastating toll that this disease has on patients, as well as the critical need that remains for new treatment options,\u201d said <\/em><strong><em>Elyse Seltzer, M.D., Chief Medical Officer of SynOx Therapeutics.<\/em><\/strong><\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cBased on our clinical work to date, we believe that emactuzumab has significant potential to address key patient needs by offering an effective, short-course treatment with rapid onset and a durable response that allows individuals suffering from TGCT to better manage their disease and move forward with their lives,\u201d she added. \u201cWe look forward to completing the ongoing TANGENT study and progressing emactuzumab toward potential commercialization.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-bristol-myers-squibb-s-opdivo-yervoy-combo-gets-fda-approval-for-first-line-treatment-of-advanced-liver-cancer\"><span class=\"ez-toc-section\" id=\"Bristol_Myers_Squibbs_OPDIVO_YERVOY_Combo_Gets_FDA_Approval_for_First-Line_Treatment_of_Advanced_Liver_Cancer\"><\/span>Bristol Myers Squibb\u2019s OPDIVO + YERVOY Combo Gets FDA Approval for First-Line Treatment of Advanced Liver Cancer<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Bristol Myers Squibb<\/strong> has announced that the <strong>FDA has approved OPDIVO (nivolumab) plus YERVOY (ipilimumab) <\/strong>as a first-line treatment for adult patients with <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-hepatocellular-carcinoma-market\"><strong>unresectable or metastatic hepatocellular carcinoma (HCC)<\/strong><\/a><strong>,<\/strong> the most common type of primary liver cancer. The decision is based on the global Phase III CheckMate-9DW trial, which showed the combination therapy significantly improved overall survival (OS) and overall response rate (ORR) compared to lenvatinib or sorafenib monotherapy in patients who had not received prior systemic therapy.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cThe CheckMate-9DW approval is an important advancement for patients, considering the incidence of liver cancer has tripled in the last four decades, yet prognosis for HCC patients remains poor,\u201d said Aiwu Ruth He, MD, PhD, a CheckMate-9DW study investigator. \u201cThe availability of a new first-line treatment option that demonstrated a deep response can offer adults with this form of liver cancer long-term overall survival and may help address an unmet need. Given the strength of evidence from the trial, especially considering the selection and performance of a strong comparator arm, I believe that OPDIVO plus YERVOY has the potential to become a standard of care for the first-line treatment of patients with unresectable or metastatic HCC.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>In the<strong> CheckMate-9DW trial<\/strong>, OPDIVO plus YERVOY (n=335) achieved a median OS of 23.7 months compared to 20.6 months with lenvatinib or sorafenib (n=333), reducing the risk of death by 21% (HR=0.79; P=0.0180). The three-year OS rate was 38% with OPDIVO plus YERVOY versus 24% in the comparator arm. The combination also showed a significantly higher ORR of 36.1% vs. 13.2%, with complete responses observed in 6.9% of patients versus 1.8%, and partial responses in 29.3% vs. 11.4%. Median duration of response (mDOR) was 30.4 months with the dual immunotherapy compared to 12.9 months with the TKIs. No new safety signals were reported.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cBringing OPDIVO plus YERVOY to patients with HCC in the first-line setting is a testament to our ongoing commitment to research and delivering important progress for people living with cancer,\u201d said Wendy Short Bartie, senior vice president of Oncology Commercialization at Bristol Myers Squibb. \u201cToday\u2019s approval builds on the legacy of our dual immunotherapy and the value it has brought to patients for years. We are thrilled to add this indication for this important therapy \u2013 our second approval for OPDIVO plus YERVOY in the gastrointestinal space this week alone \u2013 and look forward to providing a new first-line treatment option to patients in need.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>OPDIVO plus YERVOY previously received accelerated approval in 2020 for second-line use in advanced HCC based on the Phase I\/II CheckMate-040 trial. The new FDA decision not only converts that to a full approval but also expands its use into the first-line setting based on the CheckMate-9DW results.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-soleno-launches-vykat-xr-the-first-approved-therapy-for-pws-related-hyperphagia\"><span class=\"ez-toc-section\" id=\"Soleno_Launches_VYKAT_XR_The_First_Approved_Therapy_for_PWS-Related_Hyperphagia\"><\/span>Soleno Launches VYKAT XR, The First Approved Therapy for PWS-Related Hyperphagia<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Soleno Therapeutics<\/strong> has announced the <strong>U.S. commercial availability <\/strong>of <strong>VYKAT XR (diazoxide choline) <\/strong>extended-release tablets, the first and only FDA-approved treatment for <strong>hyperphagia <\/strong>in <strong>individuals <\/strong>with <a href=\"https:\/\/www.delveinsight.com\/report-store\/prader-willi-syndrome-market\"><strong>Prader-Willi syndrome (PWS)<\/strong><\/a> aged four years and older. The company confirmed that prescriptions of VYKAT XR have now been delivered to the first patients since its <strong><em>FDA approval on March 26, 2025.<\/em><\/strong><\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>\u201cWe are extremely pleased to begin delivering VYKAT XR, the only FDA-approved treatment for hyperphagia, to individuals living with PWS. Hyperphagia, the hallmark condition of PWS, is the leading cause of mortality in the PWS population and creates a significant burden for caregivers,\u201d said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. \u201cSince FDA approval, we have seen strong interest in VYKAT XR. Our team is fully prepared to meet demand and is well-positioned to execute a successful commercial launch of this first-to-market treatment. These first shipments mark an important step in our efforts to deliver this new treatment to the PWS community and are an exciting milestone reflecting our dedication to ensuring timely access to treatment.\u201d<\/em><\/p>\n<\/blockquote>\n\n\n\n<p><em>Curious to learn more about the latest breakthroughs in Prader-Willi syndrome treatment?<\/em><\/p>\n\n\n\n<p><strong><em>Check out our in-depth blog: \u201c<\/em><\/strong><a href=\"https:\/\/www.delveinsight.com\/blog\/evolving-prader-willi-syndrome-treatments\"><strong><em>Advances in Prader-Willi Syndrome Treatment: New Hope for Patients.<\/em><\/strong><\/a><strong><em>\u201d<\/em><\/strong><\/p>\n\n\n\n<p>Originally approved by the FDA in March, VYKAT XR represents a major breakthrough as the first drug approved to treat hyperphagia in PWS. The once-daily extended-release tablet acts as a potassium channel activator, targeting channels that help regulate insulin secretion, including those in the pancreas. Prader-Willi syndrome is a rare genetic condition characterized by low muscle tone, short stature, intellectual and developmental challenges, and chronic hyperphagia, which leads to life-threatening obesity if unmanaged.<\/p>\n\n\n\n<p>Based on average weight data from clinical trials, VYKAT XR is expected to cost approximately USD 466,200 annually. Formerly known as DCCR, VYKAT XR was anticipated to become available in April 2025\u2014and now it is.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Cellenkos\u2019 CK0801 Granted FDA Orphan Drug Designation for Aplastic Anemia Cellenkos\u00ae Inc. announced that the FDA has granted Orphan Drug Designation to CK0801, its off-the-shelf, allogeneic T regulatory (Treg) cell therapy, for the treatment of Aplastic Anemia\u2014a rare and life-threatening bone marrow failure disorder affecting fewer than 200,000 individuals in the U.S. The designation provides [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":31481,"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":[16984,16983,1499,204,704,5996,5997,17766,349,420,639,21116,22500,22499,18980,5789],"industry":[17225],"therapeutic_areas":[17238,17233,17228],"class_list":["post-31480","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-alagille-syndrome","tag-alagille-syndrome-market","tag-anemia","tag-delveinsight","tag-fda","tag-hepatocellular-carcinoma","tag-hepatocellular-carcinoma-market","tag-hepatocellular-carcinoma-pipeline","tag-latest-pharma-news","tag-news","tag-pharma-news","tag-prader-willi-syndrome","tag-prader-willi-syndrome-drugs","tag-prader-willi-syndrome-market","tag-progressive-familial-intrahepatic-cholestasis","tag-recent-pharma-news","industry-pharmaceutical","therapeutic_areas-genetic-disorders","therapeutic_areas-hematological-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 | Cellenkos, Mirum, Soleno<\/title>\n<meta name=\"description\" content=\"Cellenkos\u2019 CK0801, Mirum\u2019s LIVMARLI, SynOx\u2019s Emactuzumab, BMS\u2019 OPDIVO + YERVOY, Soleno\u2019s VYKAT XR launched\" \/>\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-cellenkos-mirum-soleno\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Cellenkos, Mirum, Soleno\" \/>\n<meta property=\"og:description\" content=\"Cellenkos\u2019 CK0801, Mirum\u2019s LIVMARLI, SynOx\u2019s Emactuzumab, BMS\u2019 OPDIVO + YERVOY, Soleno\u2019s VYKAT XR launched\" \/>\n<meta property=\"og:url\" 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