Announced completion of the rolling submission of the US sBLA for VOYXACT. Stated there is currently no change to the consolidated earnings forecast for the fiscal year ending December 2026 and emphasized positioning VOYXACT as a long-term growth driver.<\/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,"price_fetched_at":"","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\u2606\u2606","jir_publication_date":"2026-10-07","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/10\/4578-20261007-01.pdf","jir_short_summary":"Announced completion of the rolling submission of the US sBLA for VOYXACT. Stated there is currently no change to the consolidated earnings forecast for the fiscal year ending December 2026 and emphasized positioning VOYXACT as a long-term growth driver.","jir_summary":"### Overview of the News\nOtsuka Holdings Co., Ltd.'s wholly owned subsidiary Otsuka Pharmaceutical's U.S. subsidiary OPDC announced that it has completed the rolling submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for VOYXACT (cibeplernimab), a treatment for IgA nephropathy. While there is currently no change to the consolidated earnings forecast for the fiscal year ending December 2026, the company positions VOYXACT as one of the products driving medium- to long-term growth and regards this progress as an important development that can enhance corporate value.\n\n### Impact on Investors and Outlook\nThe current disclosure leaves short-term financial impact unclear, but emphasizes that approval progress for VOYXACT supports long-term growth. Completion of the rolling sBLA submission outlines a path to market expansion and implies potential revenue contribution upon approval; however, no specific sales forecasts or launch timelines are provided at this time. The explicit statement that there is no change to the consolidated earnings forecast for fiscal 2026 suggests limited near-term impact.","jir_financial_highlights":"Presence of consolidated earnings forecast for FY ending December 2026: Unknown (Stated as no change)","jir_category":"","jir_hashtags":"#OtsukaHoldings, #VOYXACT, #Biopharmaceuticals","jir_key_figures":"Progress in VOYXACT approval process (completion of rolling sBLA submission)\nNo change to consolidated earnings forecast for FY ending December 2026\nPositioning VOYXACT as a core medium- to long-term growth driver","jir_meta_title":"Otsuka Holdings: Completion of US sBLA Rolling Submission for VOYXACT\uff5cPositioned as Medium- to Long-Term Growth Driver","jir_meta_description":"Otsuka Group announced completion of the rolling sBLA submission to the US FDA for VOYXACT, an IgA nephropathy treatment. There is currently no change to the consolidated earnings forecast, and VOYXACT is positioned as a pillar of medium- to long-term growth.","jir_og_title":"Completion of sBLA Rolling Submission for VOYXACT\uff5cOtsuka Holdings Co., Ltd.","jir_og_description":"Announced completion of the US sBLA submission for VOYXACT. No change to the forecast for FY ending December 2026 at this time. Expected to be one of the medium- to long-term growth drivers.","jir_og_image_url":"\/assets\/og\/company-product_announcement.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-128234","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n