VOYXACT (sibepremlimab) for IgA nephropathy: final Phase 3 analysis presented at ASN Kidney Week 2026. Demonstrated renal function stabilization and a large reduction in risk of composite renal events (97.1%); safety profile comparable to placebo. sBLA submission to the FDA completed to pursue full approval.<\/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\u2605\u2606","jir_publication_date":"2026-10-23","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/10\/4578-20261023-01.pdf","jir_short_summary":"VOYXACT (sibepremlimab) for IgA nephropathy: final Phase 3 analysis presented at ASN Kidney Week 2026. Demonstrated renal function stabilization and a large reduction in risk of composite renal events (97.1%); safety profile comparable to placebo. sBLA submission to the FDA completed to pursue full approval.","jir_summary":"### Progress in New Drug Development\nOtsuka Pharmaceutical Group's VOYXACT (sibepremlimab) announced the final analysis results of the VISIONARY Phase 3 trial for IgA nephropathy. Over two years, it reduced the risk of renal function decline and renal failure events by 97.1%, meeting KDIGO 2025 treatment objectives (suppressing annual renal function decline). The safety profile over 24 months was comparable to placebo with no new safety concerns identified.\n\n### Regulatory Path and Corporate Value\nA supplemental Biologics License Application (sBLA) for VOYXACT has been submitted to the FDA in stages. This represents an important milestone toward obtaining full approval. The development is viewed as a medium- to long-term growth driver and is expected to contribute to enhanced corporate value.","jir_financial_highlights":"Consolidated Earnings Forecast: Unknown (Unknown)\nFDA Approval Process: sBLA submission completed (Progress following Phase 3 results)","jir_category":"","jir_hashtags":"#OtsukaHoldings, #Pharmaceuticals, #IgAN, #APRILInhibition, #VOYXACT","jir_key_figures":"Reduction in risk of composite renal events over 2 years: 97.1% (sibepremlimab group vs placebo group)\nReduction in 24-hour urine protein\/creatinine ratio (uPCR) at 24 months: 61.3% reduction\nLeast squares mean change from baseline in eGFR (at 24 months): sibepremlimab group +1.3 mL\/min\/1.73 m\u00b2, placebo group -7.9 mL\/min\/1.73 m\u00b2, between-group difference +9.2\nNumber of patients initiating renal replacement therapy: sibepremlimab group 0, placebo group 5 cases\nDate of sBLA submission completion for FDA approval: 2026-10-06","jir_meta_title":"Otsuka Holdings Co., Ltd. Announces Final Phase 3 Results for IgA Nephropathy Treatment\uff5cOctober 2026","jir_meta_description":"Otsuka Holdings' VOYXACT (sibepremlimab) showed renal function preservation and disease progression suppression in the final Phase 3 analysis for IgA nephropathy and has completed sBLA submission to the FDA. Summary of clinical efficacy, safety, and regulatory outlook for investors.","jir_og_title":"Otsuka Holdings Co., Ltd. Announces Final Phase 3 Results for IgA Nephropathy Treatment\uff5cOctober 2026","jir_og_description":"Two-year efficacy and safety data for VOYXACT were reported at ASN, showing renal function preservation and a large reduction in composite renal events, with sBLA submission to the FDA progressed. Important news as a medium- to long-term growth driver.","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-133547","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n