{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-112624","form_type":"8-K","ticker":"GANX","cik":"0001819411","company_name":"Gain Therapeutics, Inc.","filed_at":"2026-10-01T13:16:02+00:00","discovered_at":"2026-10-01T13:17:00.263203+00:00","generated_at":"2026-10-12T14:18:39.922031+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Gain Therapeutics' rexaceract holds MDS-UPDRS scores stable over 12 months; Phase 2 in Parkinson's set for Q1 2027","bullets":["12 of 13 evaluable patients completed the full 12-month rexaceract dosing in the Phase 1b open-label extension; one remaining participant finishes in November 2026.","MDS-UPDRS Parts II+III motor scores remained stable over 360 days, versus the ~6-point annual increase generally accepted as clinically meaningful PD progression.","Company expects to submit a new Phase 2 protocol to the FDA in coming weeks and initiate the Phase 2 trial in people with Parkinson's disease in Q1 2027.","No new safety signals over 12 months; a lower incidence of treatment-emergent adverse events occurred in the nine-month extension (Part 2) than in the initial three-month dosing (Part 1).","High and low baseline CSF GluSph patients both showed stable motor scores at 12 months; high-baseline patients had large GluSph drops toward healthy levels by day 90 and faster response."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-112624","json":"https://secwatch.observer/filing/0001104659-26-112624.json","markdown":"https://secwatch.observer/filing/0001104659-26-112624.md","text":"https://secwatch.observer/filing/0001104659-26-112624.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1819411/000110465926112624/0001104659-26-112624-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1819411/000110465926112624/tm2626750d1_8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T14:18:39.922031+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"}