{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-129494","form_type":"8-K","ticker":"TSHA","cik":"0001806310","company_name":"Taysha Gene Therapies, Inc.","filed_at":"2025-05-28T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.801550+00:00","generated_at":"2026-05-20T08:32:42.209176+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Taysha Gene Therapies Announces FDA Alignment on Pivotal Part B Trial Design for TSHA-102 in Rett Syndrome","bullets":["100% of 10 patients in Part A gained/regained ≥1 developmental milestone post-TSHA-102, with ~0% likelihood from natural history data.","FDA supports single-arm open-label pivotal trial (N=15) with primary endpoint of developmental milestone gain/regain in patients ≥6 years.","High dose outperformed low dose, with dose-dependent effects deepening over time; no treatment-related SAEs or DLTs.","Analysis of IRSF natural history study (N~1100) showed patients ≥6 years in developmental plateau, <6.7% likelihood of milestone gain.","Company expects to submit protocol this quarter and initiate pivotal trial in Q3 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-129494","json":"https://secwatch.observer/filing/0001193125-25-129494.json","markdown":"https://secwatch.observer/filing/0001193125-25-129494.md","text":"https://secwatch.observer/filing/0001193125-25-129494.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1806310/000119312525129494/0001193125-25-129494-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1806310/000119312525129494/d904503d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud","generated_at":"2026-05-20T08:32:42.209176+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"}