{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-011938","form_type":"8-K","ticker":"GRCE","cik":"0001444192","company_name":"Grace Therapeutics, Inc.","filed_at":"2023-04-05T23:59:59+00:00","discovered_at":"2026-05-14T18:03:38.891384+00:00","generated_at":"2026-06-17T05:48:35.162544+00:00","sec_items":["5.02","7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Acasti appoints Prashant Kohli as CEO; FDA allows Phase 3 safety study for GTX-104 to proceed","bullets":["Prashant Kohli appointed CEO effective April 4, 2023, succeeding Jan D'Alvise who mutually agreed to depart.","FDA Type C meeting response: concurred with 505(b)(2) pathway for GTX-104; Phase 3 safety study can proceed pending final protocol approval.","Phase 3 trial: 1:1 randomized vs oral nimodipine in aSAH patients at 25-30 US sites; primary endpoint is safety (hypotension adverse events).","First patient enrollment expected in H2 2023; if primary endpoint met, NDA filing under 505(b)(2) expected to follow."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-011938","json":"https://secwatch.observer/filing/0000950170-23-011938.json","markdown":"https://secwatch.observer/filing/0000950170-23-011938.md","text":"https://secwatch.observer/filing/0000950170-23-011938.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1444192/000095017023011938/0000950170-23-011938-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1444192/000095017023011938/acst-20230404.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-17T05:48:35.162544+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[{"claim_id":"43da139427","claim":"Jan D'Alvise departed as Director at Grace Therapeutics, Inc..","evidence_excerpt":"Ms. D'Alvise will also be stepping down from the Company's board of directors.","evidence_source":"SEC 8-K Item 5.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1444192/000095017023011938/0000950170-23-011938-index.htm","confidence":0.95,"family_label":"Executive change","details":[{"label":"Action","value":"stepping down"},{"label":"Role","value":"Director"}],"fact_type":"executive_change"},{"claim_id":"6087b722cb","claim":"Jan D'Alvise departed as Chief Executive Officer at Grace Therapeutics, Inc..","evidence_excerpt":"succeeding Jan D'Alvise, who has mutually agreed with the Company to depart.","evidence_source":"SEC 8-K Item 5.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1444192/000095017023011938/0000950170-23-011938-index.htm","confidence":0.95,"family_label":"Executive change","details":[{"label":"Action","value":"mutually agreed to depart"},{"label":"Role","value":"Chief Executive Officer"}],"fact_type":"executive_change"},{"claim_id":"c07925a063","claim":"Prashant Kohli was appointed as Chief Executive Officer at Grace Therapeutics, Inc..","evidence_excerpt":"On April 4, 2023, Acasti Pharma Inc. (the \"Company\") announced it has appointed Prashant Kohli as the Company's Chief Executive Officer, succeeding Jan D'Alvise, who has mutually agreed with the Company to depart.","evidence_source":"SEC 8-K Item 5.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1444192/000095017023011938/0000950170-23-011938-index.htm","confidence":0.95,"family_label":"Executive change","details":[{"label":"Action","value":"appointed"},{"label":"Role","value":"Chief Executive Officer"}],"fact_type":"executive_change"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}