{"filing":{"accession_number":"0001140361-26-029837","cik":"0001444192","ticker":"GRCE","company_name":"Grace Therapeutics, Inc.","form":"8-K","filing_date":"2026-07-28","report_date":"2026-07-28","primary_document":"ef20078866_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1444192/000114036126029837/ef20078866_8k.htm"},"events":[{"id":20901,"run_id":18821,"accession_number":"0001140361-26-029837","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"Grace Therapeutics announced receipt of FDA Type A Meeting minutes regarding its GTx-104 NDA resubmission strategy following a Complete Response Letter. The FDA did not identify clinical safety or efficacy deficiencies but cited cGMP compliance and manufacturing-related items. The company is advancing a dual-source manufacturing strategy with a U.S.-based second manufacturer. This is a material regulatory and operational milestone affecting the company's path to drug approval, but does not fit neatly into specific categories like earnings, M\u0026A, or litigation—it is a significant operational/regulatory development in the drug development process.","company_name":"Grace Therapeutics, Inc.","ticker":"GRCE","filing_date":"2026-07-28","form":"8-K","submitted_at":null,"items":[{"id":20405,"accession_number":"0001140361-26-029837","item_number":"8.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Grace Therapeutics announced receipt of FDA Type A Meeting minutes regarding its GTx-104 NDA resubmission strategy following a Complete Response Letter. The FDA did not identify clinical safety or efficacy deficiencies but cited cGMP compliance and manufacturing-related items. The company is advancing a dual-source manufacturing strategy with a U.S.-based second manufacturer. This is a material regulatory and operational milestone affecting the company's path to drug approval, but does not fit neatly into specific categories like earnings, M\u0026A, or litigation—it is a significant operational/regulatory development in the drug development process.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-28T11:17:38.424446+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":20405,"accession_number":"0001140361-26-029837","item_number":"8.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Grace Therapeutics announced receipt of FDA Type A Meeting minutes regarding its GTx-104 NDA resubmission strategy following a Complete Response Letter. The FDA did not identify clinical safety or efficacy deficiencies but cited cGMP compliance and manufacturing-related items. The company is advancing a dual-source manufacturing strategy with a U.S.-based second manufacturer. This is a material regulatory and operational milestone affecting the company's path to drug approval, but does not fit neatly into specific categories like earnings, M\u0026A, or litigation—it is a significant operational/regulatory development in the drug development process.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-28T11:17:38.424446+00:00","company_name":"Grace Therapeutics, Inc.","ticker":"GRCE","filing_date":"2026-07-28"}]}