{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-023004","form_type":"8-K","ticker":"FDMT","cik":"0001650648","company_name":"4D Molecular Therapeutics, Inc.","filed_at":"2023-02-03T23:59:59+00:00","discovered_at":"2026-05-14T18:03:46.004380+00:00","generated_at":"2026-06-20T01:08:43.853244+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA clears IND for 4D-150 DME trial; places clinical hold on 4D-310 Fabry program after aHUS cases","bullets":["FDA cleared IND for 4D-150 in diabetic macular edema; Phase 2 SPECTRA trial enrollment expected Q3 2023.","Initial 4D-150 wet AMD data showed >95% reduction in annualized anti-VEGF injections; Phase 2 PRISM enrolling.","4D-310 Fabry program placed on clinical hold by FDA after 3 atypical hemolytic uremic syndrome cases; no new enrollment.","Improvements in cardiac endpoints observed in 3 of 6 4D-310 patients at 12 months; FDA allows long-term follow-up."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-023004","json":"https://secwatch.observer/filing/0001193125-23-023004.json","markdown":"https://secwatch.observer/filing/0001193125-23-023004.md","text":"https://secwatch.observer/filing/0001193125-23-023004.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1650648/000119312523023004/0001193125-23-023004-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1650648/000119312523023004/d435190d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-20T01:08:43.853244+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"}