{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-129849","form_type":"8-K/A","ticker":"TSHA","cik":"0001806310","company_name":"Taysha Gene Therapies, Inc.","filed_at":"2025-05-29T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.801135+00:00","generated_at":"2026-05-20T06:15:02.275417+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Taysha reports FDA-aligned pivotal trial for TSHA-102; 100% of Part A patients gained milestones","bullets":["FDA aligned on single-arm pivotal Part B trial (N=15) for TSHA-102 in Rett syndrome patients ≥6 years; primary endpoint: developmental milestone gain/regain.","Part A: 100% (10/10) of patients aged 6-21 gained ≥1 milestone; high dose showed faster and deeper effects vs low dose.","Natural history data (~1,100 patients) showed ~0% likelihood of milestone gain/regain after age 6, supporting trial design.","No treatment-related SAEs or DLTs; all related AEs mild-to-moderate across 12 patients.","Company suspended $100M ATM prospectus; Sales Agreement remains in effect; new prospectus required for future sales."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-129849","json":"https://secwatch.observer/filing/0001193125-25-129849.json","markdown":"https://secwatch.observer/filing/0001193125-25-129849.md","text":"https://secwatch.observer/filing/0001193125-25-129849.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1806310/000119312525129849/0001193125-25-129849-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1806310/000119312525129849/d907074d8ka.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-20T06:15:02.275417+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"}