Achieved primary endpoints in the Phase III trial of Daridorexant in South Korea; manufacturing and marketing approval application planned for Q1 2026, with approval expected in Q1 2027.<\/p>\n","protected":false},"comment_status":"open","ping_status":"closed","template":"","meta":{"Ticker":"","DATE":"","longName":"","company_name_ja":"","fullTimeEmployees":0,"address":"","phone":"","website":"","industry":"","sector":"","regularMarketPrice":0,"financialCurrency":"","marketCap":0,"fiftyTwoWeekLow":0,"fiftyTwoWeekHigh":0,"epsTrailingTwelveMonths":0,"epsForward":0,"bookValue":0,"totalRevenue":0,"OperatingIncome":0,"operatingMargins":0,"NetIncome":0,"profitMargins":0,"ebitda":0,"trailingPE":0,"forwardPE":0,"priceToBook":0,"returnOnEquity":0,"recommendationMean":0,"recommendationKey":"","targetMeanPrice":0,"numberOfAnalystOpinions":0,"analyst_earnings_data":"","dividendRate":0,"dividendYield":0,"payoutRatio":0,"totalEsg":0,"environmentScore":0,"socialScore":0,"governanceScore":0,"title":"","providerPublishTime":"","link":"","longBusinessSummary":"","longBusinessSummary_ja":"","quarterly_revenue":0,"quarterly_net_income":0,"quarterly_operating_profit":0,"enterprise_value":0,"company_officer_1_name":"","company_officer_1_title":"","company_officer_2_name":"","company_officer_2_title":"","company_officer_3_name":"","company_officer_3_title":"","company_officer_4_name":"","company_officer_4_title":"","company_officer_5_name":"","company_officer_5_title":"","company_officers_update_time":"","get_dividend_history_year1":0,"get_dividend_history_year2":0,"get_dividend_history_year3":0,"get_dividend_history_year4":0,"get_dividend_history_year5":0,"get_dividend_history_year6":0,"get_dividend_history_year7":0,"get_dividend_history_year8":0,"get_dividend_history_year9":0,"get_dividend_history_year10":0,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"jir_stock_code":"4565","jir_company_name":"Nexera Pharma Co., Ltd.","jir_importance":"\u2605\u2605\u2605\u2605\u2606","jir_publication_date":"2026-01-19","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/01\/4565-20260119-01.pdf","jir_short_summary":"Achieved primary endpoints in the Phase III trial of Daridorexant in South Korea; manufacturing and marketing approval application planned for Q1 2026, with approval expected in Q1 2027.","jir_summary":"### Phase III Trial Results and Future Outlook\nNexera Pharma Co., Ltd. reported favorable results from the randomized, double-blind, placebo-controlled Phase III trial of the dual orexin receptor antagonist Daridorexant 50mg conducted in South Korea. The study significantly improved the primary endpoint of total sleep time (sTST) and the secondary endpoints of sleep latency (sLSO) and wake time after sleep onset (sWASO). The incidence of adverse events was comparable to the placebo group, confirming safety. The company plans to file for manufacturing and marketing approval in South Korea in Q1 2026, with approval expected in Q1 2027.\n\n### Product Market Deployment and Company Overview\nDaridorexant is marketed in Japan as \u201cQuviviq\u00ae Tablets\u201d through a partnership with Shionogi & Co., Ltd. It is also available in the United States, Canada, Europe, China, and Hong Kong. Insomnia affects approximately 6.5 to 11 million adults, representing 15\u201325% of the adult population in South Korea. Nexera Pharma\u2019s subsidiary, Nxera Pharma Korea, is preparing for manufacturing and marketing approval acquisition in the South Korean market. Nexera Pharma is a biopharmaceutical company developing numerous pipelines leveraging its \u201cNxWave\u2122\u201d drug discovery platform.","jir_financial_highlights":"Impact on consolidated results for the fiscal year ending December 2026: Minimal (Unknown)","jir_category":"","jir_hashtags":"#NexeraPharmaCoLtd, #NewProductAnnouncement, #JapaneseStocks","jir_key_figures":"Significant improvement in primary endpoint total sleep time (sTST) with p<0.0001\nSignificant improvements in secondary endpoints sleep latency (sLSO) and wake time after sleep onset (sWASO) with p<0.0001\nAdverse event incidence rate: Daridorexant group 13.41%, placebo group 14.81%\nPlanned manufacturing and marketing approval application in South Korea: Q1 2026\nExpected approval in South Korea: Q1 2027","jir_meta_title":"Nexera Pharma Reports Positive Phase III Results of Daridorexant in South Korea, Approval Application Scheduled for 2026","jir_meta_description":"Nexera Pharma Co., Ltd. achieved primary endpoints in the Phase III trial of Daridorexant in South Korea and announced plans to file for manufacturing and marketing approval in Q1 2026, with anticipated approval in Q1 2027.","jir_og_title":"Nexera Pharma Reports Positive Phase III Results of Daridorexant in South Korea","jir_og_description":"Achieved primary endpoints in the Phase III trial of Daridorexant in South Korea. Approval application planned for Q1 2026, with expected approval in Q1 2027.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":16880,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"product_announcement","footnotes":""},"sector":[],"importance":[],"class_list":["post-19722","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n