{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-131084","form_type":"8-K","ticker":"GANX","cik":"0001819411","company_name":"Gain Therapeutics, Inc.","filed_at":"2024-12-23T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.816164+00:00","generated_at":"2026-05-28T23:46:31.473864+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Gain Therapeutics receives Australian approval to start Phase 1b trial of GT-02287 for Parkinson's disease","bullets":["Australian ethics approval obtained for Phase 1b trial of GT-02287 in GBA1-PD and idiopathic PD patients.","Trial will dose 13.5 mg/kg/day for three months; primary endpoint safety/tolerability; secondary endpoints include biomarkers.","Enrollment expected to complete spring 2025; data anticipated mid-2025.","Phase 1 in healthy volunteers showed safety, CNS exposure, and >50% increase in GCase activity (statistically significant).","Company plans Phase 2 preparation after Phase 1b results."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-131084","json":"https://secwatch.observer/filing/0001104659-24-131084.json","markdown":"https://secwatch.observer/filing/0001104659-24-131084.md","text":"https://secwatch.observer/filing/0001104659-24-131084.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1819411/000110465924131084/0001104659-24-131084-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1819411/000110465924131084/tm2431811d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-28T23:46:31.473864+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":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}