{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-24-007115","form_type":"8-K","ticker":"MTNB","cik":"0001582554","company_name":"Matinas BioPharma Holdings, Inc.","filed_at":"2024-02-20T23:59:59+00:00","discovered_at":"2026-05-14T18:03:24.698689+00:00","generated_at":"2026-06-05T23:05:07.226485+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA agrees on Phase 3 trial design for Matinas' MAT2203 in invasive aspergillosis","bullets":["FDA agreed on design of single Phase 3 ORALTO trial for MAT2203 in invasive aspergillosis; primary endpoint all-cause mortality at day 42.","Trial will enroll ~216 adults with limited treatment options; 2:1 randomization to oral MAT2203 vs continued AmBisome + SOC.","Key secondary endpoint: superiority of MAT2203 over AmBisome for treatment-related toxicities leading to treatment changes.","Enrollment expected to begin H2 2024, complete in ~24 months at ~65 sites across US, Europe, South America, Middle East, Asia Pacific.","CEO says FDA alignment provides certainty to advance partnership discussions; product not yet approved."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-24-007115","json":"https://secwatch.observer/filing/0001493152-24-007115.json","markdown":"https://secwatch.observer/filing/0001493152-24-007115.md","text":"https://secwatch.observer/filing/0001493152-24-007115.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1582554/000149315224007115/0001493152-24-007115-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1582554/000149315224007115/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-05T23:05:07.226485+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"}