{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-061539","form_type":"8-K","ticker":"FNCHQ","cik":"0001733257","company_name":"Finch Therapeutics Group, Inc.","filed_at":"2022-03-01T23:59:59+00:00","discovered_at":"2026-05-14T18:04:07.982717+00:00","generated_at":"2026-06-27T03:06:38.976682+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Finch Therapeutics pauses Phase 3 PRISM4 trial; FDA clinical hold on CP101; dosing occurred while hold in effect","bullets":["FDA clinical hold letter Feb 24, 2022 requesting additional info on SARS-CoV-2 donor screening protocols.","Company paused enrollment in PRISM4 Phase 3 trial of CP101 for recurrent C. difficile infection.","Company informed FDA that participants were dosed while clinical hold was in effect; conducting a review of the matter.","FDA letter did not reference any adverse clinical outcomes in Finch's trials.","Company evaluating impact on timing of expected topline data readout from PRISM4."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-061539","json":"https://secwatch.observer/filing/0001193125-22-061539.json","markdown":"https://secwatch.observer/filing/0001193125-22-061539.md","text":"https://secwatch.observer/filing/0001193125-22-061539.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1733257/000119312522061539/0001193125-22-061539-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1733257/000119312522061539/d292195d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-27T03:06:38.976682+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"}