{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-040675","form_type":"8-K","ticker":"IRD","cik":"0001228627","company_name":"Opus Genetics, Inc.","filed_at":"2025-11-06T23:59:59+00:00","discovered_at":"2026-05-14T18:02:38.984631+00:00","generated_at":"2026-05-16T23:23:14.069266+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Opus Genetics raises $23M in direct offering and secures FDA guidance for LCA5 gene therapy trial","bullets":["$23M registered direct offering led by Perceptive Advisors and Balyasny Asset Management; closes Nov 7, 2025.","Offering: 3.83M shares at $2.09/sh and pre-funded warrants for 7.18M shares at $2.0899.","FDA RMAT meeting provides guidance on registration strategy; Phase 3 design adaptive, as few as 8 participants.","Phase 1/2 data: all 6 late-stage participants achieved clinically meaningful vision improvements.","First participant enrolled in run-in; dosing H2 2026, topline ~1 year later; cash runway into H2 2027."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-040675","json":"https://secwatch.observer/filing/0001140361-25-040675.json","markdown":"https://secwatch.observer/filing/0001140361-25-040675.md","text":"https://secwatch.observer/filing/0001140361-25-040675.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1228627/000114036125040675/0001140361-25-040675-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1228627/000114036125040675/ny20058362x4_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T23:23:14.069266+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"}