{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-22-005537","form_type":"8-K","ticker":"TGTX","cik":"0001001316","company_name":"TG THERAPEUTICS, INC.","filed_at":"2022-04-18T23:59:59+00:00","discovered_at":"2026-05-14T18:03:59.211087+00:00","generated_at":"2026-06-26T06:45:54.714699+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 withdraws BLA/sNDA for U2 in CLL/SLL; pulls UKONIQ from sale","bullets":["Voluntarily withdrew BLA/sNDA for U2 (ublituximab + umbralisib) for CLL/SLL based on updated OS data imbalance favoring control arm.","Withdrew UKONIQ (umbralisib) from sale for accelerated-approved MZL and FL indications; FDA expected to withdraw approval.","UNITY-CLL Phase 3 met primary PFS endpoint but updated OS showed increasing imbalance; ODAC meeting canceled.","Company to focus on ublituximab BLA for relapsing MS (PDUFA Sept 28, 2022); conference call April 18 at 8:30 AM ET."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-22-005537","json":"https://secwatch.observer/filing/0001558370-22-005537.json","markdown":"https://secwatch.observer/filing/0001558370-22-005537.md","text":"https://secwatch.observer/filing/0001558370-22-005537.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1001316/000155837022005537/0001558370-22-005537-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1001316/000155837022005537/tgtx-20220415x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-26T06:45:54.714699+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"}