{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-22-000487","form_type":"8-K","ticker":"TGTX","cik":"0001001316","company_name":"TG THERAPEUTICS, INC.","filed_at":"2022-01-27T23:59:59+00:00","discovered_at":"2026-05-14T18:04:04.972535+00:00","generated_at":"2026-06-27T14:35:52.290537+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":"TG Therapeutics: updated UNITY-CLL OS data improves but FDA imposes partial clinical hold on U2 studies","bullets":["Updated OS hazard ratio improved vs preliminary 1.23; still not statistically significant (Sep 2021 cutoff).","FDA placed partial clinical hold on select U2 studies; no new enrollment, existing patients continue after reconsent.","Partial hold based on same data as ODAC meeting scheduled for March/April 2022; no update expected before ODAC.","Company nearing FDA submission of updated OS analysis; interim OS results may change as more events occur."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-22-000487","json":"https://secwatch.observer/filing/0001558370-22-000487.json","markdown":"https://secwatch.observer/filing/0001558370-22-000487.md","text":"https://secwatch.observer/filing/0001558370-22-000487.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1001316/000155837022000487/0001558370-22-000487-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1001316/000155837022000487/tgtx-20220127x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-27T14:35:52.290537+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"}