{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-403424","form_type":"8-K","ticker":"FDMT","cik":"0001650648","company_name":"4D Molecular Therapeutics, Inc.","filed_at":"2026-09-28T12:05:05+00:00","discovered_at":"2026-09-28T12:10:36.588644+00:00","generated_at":"2026-10-12T13:31:00.298562+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"4D Molecular enrolls first patients in 4SIGHT Phase 3 DME trial; 4D-150 shows +10.8-letter BCVA gain at 2 years","bullets":["First patients enrolled across multiple sites in 4SIGHT, a global Phase 3 trial of intravitreal 4D-150 in treatment-naive DME (N=514) vs aflibercept 2 mg Q8W.","Primary endpoint: non-inferiority in mean BCVA change from baseline at Week 52; key secondary endpoints are injection burden reduction and >=2-step ETDRS-DRSS improvement.","4D-150 has FDA Regenerative Medicine Advanced Therapy designation; company says FDA and EMA alignment supports BLA/MAA filing on the single 4SIGHT trial plus SPECTRA/PRISM data.","SPECTRA 2-year data (cutoff March 12, 2026): Phase 3 dose (3E10 vg/eye, n=9) gave +10.8 letter mean BCVA gain and -176 um CST reduction; no intraocular inflammation or ocular SAEs (N=22).","61% treatment burden reduction vs on-label aflibercept Q8W (5.2 vs 13.0 projected injections); 75% estimated under 4SIGHT criteria (3.2 injections); 2 of 9 patients injection-free."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-403424","json":"https://secwatch.observer/filing/0001193125-26-403424.json","markdown":"https://secwatch.observer/filing/0001193125-26-403424.md","text":"https://secwatch.observer/filing/0001193125-26-403424.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1650648/000119312526403424/0001193125-26-403424-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1650648/000119312526403424/d147828d8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T13:31:00.298562+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"}