{"filing":{"accession_number":"0001140361-26-025669","cik":"0001444192","ticker":"GRCE","company_name":"Grace Therapeutics, Inc.","form":"8-K","filing_date":"2026-06-18","report_date":null,"primary_document":"ef20076431_form8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1444192/000114036126025669/ef20076431_form8k.htm"},"events":[{"id":11717,"run_id":10300,"accession_number":"0001140361-26-025669","anchor_item_number":"8.01","event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.72,"summary":"Grace Therapeutics disclosed an update to its corporate presentation on June 18, 2026, which includes material regulatory and clinical information about GTx-104. The presentation details the FDA's Complete Response Letter (CRL) received in April 2026 citing CMC and manufacturing deficiencies (not clinical deficiencies), a scheduled Type A meeting with the FDA, and comprehensive Phase 3 STRIVE-ON trial data showing clinical and pharmacoeconomic benefits over oral nimodipine. While the CRL itself represents a regulatory setback, the disclosure centers on updating investors with the company's regulatory pathway forward and clinical evidence supporting GTx-104's potential. This does not fit neatly into the more specific categories (not a restatement, going concern, impairment, or litigation), but the regulatory status and clinical trial results are material to investor assessment of the company's prospects.","company_name":"Grace Therapeutics, Inc.","ticker":"GRCE","filing_date":"2026-06-18","form":"8-K","submitted_at":null,"items":[{"id":8374,"accession_number":"0001140361-26-025669","item_number":"8.01","item_title":"Other Events.","event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.72,"reasoning":"Grace Therapeutics disclosed an update to its corporate presentation on June 18, 2026, which includes material regulatory and clinical information about GTx-104. The presentation details the FDA's Complete Response Letter (CRL) received in April 2026 citing CMC and manufacturing deficiencies (not clinical deficiencies), a scheduled Type A meeting with the FDA, and comprehensive Phase 3 STRIVE-ON trial data showing clinical and pharmacoeconomic benefits over oral nimodipine. While the CRL itself represents a regulatory setback, the disclosure centers on updating investors with the company's regulatory pathway forward and clinical evidence supporting GTx-104's potential. This does not fit neatly into the more specific categories (not a restatement, going concern, impairment, or litigation), but the regulatory status and clinical trial results are material to investor assessment of the company's prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-9e0ffca5","taxonomy_version":"v1","classified_at":"2026-06-18T12:17:08.666964+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":8374,"accession_number":"0001140361-26-025669","item_number":"8.01","item_title":"Other Events.","event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.72,"reasoning":"Grace Therapeutics disclosed an update to its corporate presentation on June 18, 2026, which includes material regulatory and clinical information about GTx-104. The presentation details the FDA's Complete Response Letter (CRL) received in April 2026 citing CMC and manufacturing deficiencies (not clinical deficiencies), a scheduled Type A meeting with the FDA, and comprehensive Phase 3 STRIVE-ON trial data showing clinical and pharmacoeconomic benefits over oral nimodipine. While the CRL itself represents a regulatory setback, the disclosure centers on updating investors with the company's regulatory pathway forward and clinical evidence supporting GTx-104's potential. This does not fit neatly into the more specific categories (not a restatement, going concern, impairment, or litigation), but the regulatory status and clinical trial results are material to investor assessment of the company's prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-9e0ffca5","taxonomy_version":"v1","classified_at":"2026-06-18T12:17:08.666964+00:00","company_name":"Grace Therapeutics, Inc.","ticker":"GRCE","filing_date":"2026-06-18"}]}