{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-25-011478","form_type":"8-K","ticker":"MGTX","cik":"0001735438","company_name":"MeiraGTx Holdings plc","filed_at":"2025-08-14T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.836736+00:00","generated_at":"2026-05-17T13:18:13.377819+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"MeiraGTx Q2 net loss narrows to $38.8M; FDA alignment on RIX pivotal study, RMAT for Parkinson's","bullets":["Net loss $38.8M ($0.48/sh) vs $48.6M ($0.76/sh) in Q2 2024; cash $32.2M at June 30, 2025.","FDA aligns on AAV-hAQP1 Phase 2 AQUAx2 as potentially pivotal for BLA in radiation-induced xerostomia; enrollment target Q4 2025, data late 2026.","FDA grants RMAT designation for AAV-GAD in Parkinson's; clean GCP inspection; Phase 3 study planned in 2025.","Received $23M of $200M from Hologen collaboration; forming JV Hologen Neuro AI with up to $230M funding for AAV-GAD development.","Preparing MAA in UK and BLA in US for AAV-AIPL1 in LCA4; Lancet publication shows all 11 treated children now able to see."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-25-011478","json":"https://secwatch.observer/filing/0001558370-25-011478.json","markdown":"https://secwatch.observer/filing/0001558370-25-011478.md","text":"https://secwatch.observer/filing/0001558370-25-011478.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1735438/000155837025011478/0001558370-25-011478-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1735438/000155837025011478/mgtx-20250814x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T13:18:13.377819+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"}