{"schema_version":"secwatch.filing_event.v1","accession":"0001023024-25-000072","form_type":"8-K","ticker":"ANIP","cik":"0001023024","company_name":"ANI PHARMACEUTICALS INC","filed_at":"2025-07-23T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.145083+00:00","generated_at":"2026-05-18T03:04:27.633966+00:00","sec_items":["2.02","7.01","8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"ANI Pharma posts preliminary Q2 ILUVIEN/YUTIQ revenue of $22.3M; NEW DAY trial misses primary endpoint","bullets":["Preliminary combined ILUVIEN/YUTIQ net revenues for Q2 2025: $22.3M.","NEW DAY trial primary endpoint: mean supplemental injections 2.4 (ILUVIEN) vs. 2.5 (aflibercept); p=0.756, not significant.","Secondary endpoint met: mean time to first supplemental injection 185.4 vs. 132.8 days (p<0.001).","Post-hoc per-protocol analysis: ILUVIEN arm 1.8 vs. 2.5 supplemental injections (p=0.029); total 2.8 vs. 7.5 injections.","Safety: 41% treatment-related TEAE in ILUVIEN arm (cataract, IOP increase) vs. 3% in aflibercept arm."],"urls":{"canonical":"https://secwatch.observer/filing/0001023024-25-000072","json":"https://secwatch.observer/filing/0001023024-25-000072.json","markdown":"https://secwatch.observer/filing/0001023024-25-000072.md","text":"https://secwatch.observer/filing/0001023024-25-000072.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1023024/000102302425000072/0001023024-25-000072-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1023024/000102302425000072/ani-20250723.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T03:04:27.633966+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"}