{"schema_version":"secwatch.filing_event.v1","accession":"0001564590-22-020824","form_type":"8-K","ticker":"TXMD","cik":"0000025743","company_name":"TherapeuticsMD, Inc.","filed_at":"2022-05-20T23:59:59+00:00","discovered_at":"2026-05-14T18:04:03.097842+00:00","generated_at":"2026-06-25T08:50:45.490257+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA approves TherapeuticsMD's ANNOVERA sNDA, boosting supply by ~7,000 rings","bullets":["FDA approved sNDA for ANNOVERA with revised in vitro release testing specification to allow normal manufacturing variability.","Company expects ~7,000 additional rings to enter supply chain in Q2/Q3 2022, reducing batch rejections.","CEO Hugh O'Dowd says approval enables scaling production to meet increasing customer demand for procedure-free birth control."],"urls":{"canonical":"https://secwatch.observer/filing/0001564590-22-020824","json":"https://secwatch.observer/filing/0001564590-22-020824.json","markdown":"https://secwatch.observer/filing/0001564590-22-020824.md","text":"https://secwatch.observer/filing/0001564590-22-020824.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/25743/000156459022020824/0001564590-22-020824-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/25743/000156459022020824/txmd-8k_20220520.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-25T08:50:45.490257+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"}