{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-078848","form_type":"8-K","ticker":"GANX","cik":"0001819411","company_name":"Gain Therapeutics, Inc.","filed_at":"2026-06-29T20:21:05+00:00","discovered_at":"2026-06-29T20:22:01.435277+00:00","generated_at":"2026-06-29T20:22:25.212349+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA authorizes IND for Gain Therapeutics' GT-02287, permitting Phase 2 Parkinson's study","bullets":["FDA authorized IND for GT-02287, enabling Phase 2 clinical development in Parkinson's disease with or without GBA1 mutation.","Phase 2a study of oral GT-02287 in early Parkinson's patients planned; sites in U.S., Australia, and Europe.","Phase 2a initiation expected in Q3 2026; Phase 1a/b were conducted in Australia.","FDA clearance is a key regulatory milestone for Gain Therapeutics' lead candidate."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-078848","json":"https://secwatch.observer/filing/0001104659-26-078848.json","markdown":"https://secwatch.observer/filing/0001104659-26-078848.md","text":"https://secwatch.observer/filing/0001104659-26-078848.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1819411/000110465926078848/0001104659-26-078848-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1819411/000110465926078848/tm2619336d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-29T20:22:25.212349+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"}