The in-person advisory with PMDA regarding the domestic first-half Phase II trial of TMS-008 has ended. Preparations such as site selection and submission of the clinical trial notification will proceed as a start of the trial. The cost impact is within the already disclosed R&D cost range, and there is no impact on the results for the fiscal year ending December 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":"4891","jir_company_name":"Timms Co., Ltd.","jir_importance":"\u2605\u2605\u2605\u2606\u2606","jir_publication_date":"2026-09-11","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/09\/4891-20260911-01.pdf","jir_short_summary":"The in-person advisory with PMDA regarding the domestic first-half Phase II trial of TMS-008 has ended. Preparations such as site selection and submission of the clinical trial notification will proceed as a start of the trial. The cost impact is within the already disclosed R&D cost range, and there is no impact on the results for the fiscal year ending December 2026.","jir_summary":"### News overview\nToday, Timms announces that the in-person advisory with the PMDA for TMS-008's domestic first-half Phase II trial has ended. Going forward, concrete preparations toward trial initiation, such as site selection and filing the clinical trial notification, will proceed. The related current-period costs are included in the previously disclosed R&D cost range, and there is no impact on the FY2026 results.\n\n### Clinical development progress and outlook\nTMS-008 targets acute kidney injury after cardiac surgery and is part of a low-molecule compound family with anti-inflammatory action via sEH inhibition. Preparations for the Phase II trial are underway, and following the end of the in-person advisory, specific procedures for trial initiation will proceed. This is expected to advance the development of a new therapeutic to address unmet medical needs.","jir_financial_highlights":"R&D cost range: Unknown (Public disclosure on February 13, 2026)\nImpact on FY2026 results: Unknown (There is no impact)\nSpecific preparations for trial initiation: Unknown (Preparations begin after end of in-person advisory)","jir_category":"","jir_hashtags":"#Timms, #TMS-008, #ClinicalTrial, #R&D, #AdvisoryEnd","jir_key_figures":"Specific procedures for trial initiation: site selection, submission of the clinical trial notification (timing unknown)\nR&D cost range: Unknown\nImpact on results: No impact in FY2026","jir_meta_title":"Timms: End of PMDA in-person advisory and start of clinical trial preparations | September 2026","jir_meta_description":"Timms announces the end of the PMDA in-person advisory for TMS-008's domestic first-half Phase II trial. It will proceed with concrete preparations for trial initiation, and current-period costs are within the disclosed range with no impact on FY2026 results.","jir_og_title":"Timms announces end of PMDA advisory and start of clinical trial preparations","jir_og_description":"For TMS-008's early Phase II, PMDA in-person advisory has ended. Preparations toward trial initiation will proceed, with no cost impact disclosed.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":59627,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"executive_change","footnotes":""},"sector":[],"importance":[],"class_list":["post-113264","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n