In the Phase 3 (VISIONARY) trial of VOYXACT for IgA nephropathy, 2-year eGFR improvement and stabilization of kidney function were achieved. Progress on FDA sBLA review and preparations for filings in various countries were reported.<\/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":"4578","jir_company_name":"Otsuka Holdings Co., Ltd.","jir_importance":"\u2605\u2605\u2605\u2605\u2606","jir_publication_date":"2026-07-02","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/07\/4578-20260702-01.pdf","jir_short_summary":"In the Phase 3 (VISIONARY) trial of VOYXACT for IgA nephropathy, 2-year eGFR improvement and stabilization of kidney function were achieved. Progress on FDA sBLA review and preparations for filings in various countries were reported.","jir_summary":"### News Overview\nOtsuka Holdings, with its 100%-owned subsidiaries Otsuka Pharmaceutical and OPDC, announced that the phase 3 trial (VISIONARY) results for the IgA nephropathy drug voxycimremab (VOYXACT) were favorable for the full trial duration. The drug has already received expedited approval from the U.S. FDA in November 2025, and is in the review stage of the sBLA with the aim of obtaining the next approvals. Data showing long-term protection\/improvement of kidney function support the potential to slow CKD progression. Further conference presentations and filings in other countries are planned.\n\n### Outlook and Impact\nThis progress is viewed as an important step toward medium- to long-term corporate value enhancement, with continued advancement of the FDA approval process. While direct impact on sales plans is not yet determined, VOYXACT is positioned as a growth driver, with anticipated market expansion through international approvals.","jir_financial_highlights":"Sales: Unknown (Unknown)","jir_category":"","jir_hashtags":"#OtsukaHoldings, #VOYXACT, #IgANepathathy","jir_key_figures":"VOYXACT: Phase 3 VISIONARY trial results favorable\nFDA sBLA review ongoing\nContinued filings in various countries toward approval","jir_meta_title":"Otsuka Holdings IgA nephropathy treatment VOYXACT Phase 3 results briefing | July 2026","jir_meta_description":"Otsuka Holdings announces Phase 3 results briefing for VOYXACT (semaprilumab) with eGFR improvement and kidney function stabilization; explains progress of FDA sBLA review and the upcoming filing schedule.","jir_og_title":"Otsuka Holdings VOYXACT Phase 3 Results Briefing","jir_og_description":"VOYXACT Phase 3 trial shows improvement and stabilization of kidney function. Reports on FDA review progress and future filing plans.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":6875,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"product_announcement","footnotes":""},"sector":[],"importance":[],"class_list":["post-74897","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n