Takeda Pharmaceutical announces that the U.S. FDA has accepted the new drug application for rusfertide, co-developed with Protagonist Therapeutics, and granted it priority review designation. The target date for review completion is Q3 2026.<\/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":"4502","jir_company_name":"Takeda Pharmaceutical Company Limited","jir_importance":"\u2605\u2605\u2605\u2605\u2606","jir_publication_date":"2026-03-02","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/03\/4502-20260302-01.pdf","jir_short_summary":"Takeda Pharmaceutical announces that the U.S. FDA has accepted the new drug application for rusfertide, co-developed with Protagonist Therapeutics, and granted it priority review designation. The target date for review completion is Q3 2026.","jir_summary":"### Overview of New Drug Application\nTakeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) accepted the new drug application (NDA) for rusfertide, co-developed with Protagonist Therapeutics, on February 27, 2026, and designated it for priority review. Rusfertide is a first-in-class treatment for polycythemia vera (PV), with a PDUFA target action date set for Q3 2026 (July to September). Rusfertide is a hepcidin peptide mimetic, which, when combined with standard treatment, has demonstrated more than double the clinical response rate, significantly improving hematocrit control and reducing phlebotomy frequency.\n\n### Future Outlook and Partnership\nIn January 2024, Takeda entered into a global license and collaboration agreement with Protagonist Therapeutics for rusfertide and is leading the strategic implementation of the NDA and future regulatory submissions in the U.S. Protagonist Therapeutics holds co-promotion rights in the U.S. on a 50:50 profit-sharing basis and retains opt-out rights. Rusfertide is administered via once-weekly subcutaneous self-injections and has shown generally favorable tolerability in clinical trials. It has also received FDA designations for Breakthrough Therapy, Orphan Drug, and Fast Track, with approval anticipated within 2026.","jir_financial_highlights":"Acceptance of New Drug Application for rusfertide: 2026-02-27 (New application acceptance and priority review designation)\nTarget Date for Review Completion: Calendar Q3 2026 (July-September) (Unknown)\nTherapeutic Effect of rusfertide: More than double the clinical response rate when combined with standard treatment (Unknown)","jir_category":"","jir_hashtags":"#TakedaPharmaceutical, #NewDrugApplication, #rusfertide, #PolycythemiaVera, #product_announcement, #JapaneseStocks","jir_key_figures":"New Drug Application Acceptance Date: 2026-02-27\nTarget Date for Review Completion: Q3 2026 (July-September)\nrusfertide Key Trial: Phase 3 VERIFY trial showing more than double the clinical response rate when combined with standard treatment","jir_meta_title":"Takeda Pharmaceutical Announces FDA Acceptance and Priority Review Designation for rusfertide New Drug Application (Target Review Completion Q3 2026)","jir_meta_description":"Takeda Pharmaceutical announces that the U.S. FDA has accepted the new drug application for rusfertide, a polycythemia vera treatment co-developed with Protagonist Therapeutics, and designated it for priority review, targeting review completion in Q3 2026.","jir_og_title":"Takeda Pharmaceutical Announces FDA Acceptance and Priority Review of rusfertide New Drug Application","jir_og_description":"Takeda Pharmaceutical has received FDA acceptance and priority review designation for rusfertide\u2019s new drug application, aiming for approval in Q3 2026.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":6852,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"product_announcement","footnotes":""},"sector":[],"importance":[],"class_list":["post-32719","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n