{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-21-016373","form_type":"8-K","ticker":"TGTX","cik":"0001001316","company_name":"TG THERAPEUTICS, INC.","filed_at":"2021-11-30T23:59:59+00:00","discovered_at":"2026-05-14T18:04:10.976790+00:00","generated_at":"2026-06-28T04:44:07.878022+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA to hold ODAC meeting for TG Therapeutics' U2 BLA; PDUFA date likely extended","bullets":["FDA notified TG Therapeutics it will host an ODAC meeting for the U2 BLA/sNDA for CLL/SLL.","ODAC meeting targeted for March or April 2022; March 25, 2022 PDUFA date unlikely to be met.","Early overall survival analysis showed HR 1.23 favoring control; excluding COVID deaths HR 1.04 (not significant).","Company affirms belief in UKONIQ's differentiated safety profile and that data support approval.","Conference call scheduled for November 30, 2021 at 8:30 AM ET to discuss regulatory updates."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-21-016373","json":"https://secwatch.observer/filing/0001558370-21-016373.json","markdown":"https://secwatch.observer/filing/0001558370-21-016373.md","text":"https://secwatch.observer/filing/0001558370-21-016373.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1001316/000155837021016373/0001558370-21-016373-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1001316/000155837021016373/tgtx-20211130x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-28T04:44:07.878022+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"}