{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-419761","form_type":"8-K","ticker":"TRAX","cik":"0002091349","company_name":"First Tracks Biotherapeutics, Inc.","filed_at":"2026-10-13T12:32:55+00:00","discovered_at":"2026-10-13T12:35:00.209980+00:00","generated_at":"2026-10-13T12:35:05.723177+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"First Tracks' ANB033 hits Phase 1b celiac endpoints; Vh:Cd delta +0.49 (p=0.009), IEL density -20.03 (p<0.001)","bullets":["Vh:Cd LS mean change -0.17 on ANB033 vs -0.66 on placebo (placebo-adjusted +0.49, p=0.009); IEL density -1.20 vs +18.83 (-20.03, p<0.001).","Cohort 1 enrolled 32 patients (17 ANB033, 15 placebo) with a 14-day gluten challenge of 6g daily, about two slices of bread.","Symptoms suppressed throughout the challenge; 6% of ANB033 patients took rescue GI meds vs 47% on placebo; CDSD benefit significant from day 1.","Safety: no SAEs, no severe AEs, no discontinuations on ANB033; moderate AEs 16.7% vs 75.0% placebo; nausea 5.6% vs 43.8%; injection site erythema 27.8%.","Next: Cohort 2 mucosal healing topline Q1 2027, EoE cohort of 50 patients Q3 2027, late-stage celiac trial in 2027; FDA Fast Track already granted."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-419761","json":"https://secwatch.observer/filing/0001193125-26-419761.json","markdown":"https://secwatch.observer/filing/0001193125-26-419761.md","text":"https://secwatch.observer/filing/0001193125-26-419761.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/2091349/000119312526419761/0001193125-26-419761-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/2091349/000119312526419761/trax-20261012.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-13T12:35:05.723177+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"}