{"schema_version":"secwatch.filing_event.v1","accession":"0001157523-22-001777","form_type":"8-K","ticker":"ALDX","cik":"0001341235","company_name":"Aldeyra Therapeutics, Inc.","filed_at":"2022-12-21T23:59:59+00:00","discovered_at":"2026-05-14T18:03:50.274948+00:00","generated_at":"2026-06-21T00:43:52.725586+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Aldeyra submits NDA to FDA for ADX-2191 for primary vitreoretinal lymphoma","bullets":["NDA submitted for ADX-2191 (methotrexate) for primary vitreoretinal lymphoma, a rare cancer with no FDA-approved therapy.","Supported by published literature and Phase 3 GUARD trial safety data; no serious adverse events observed; punctate keratitis most common AE.","ADX-2191 has FDA Orphan Drug Designation; Priority Review requested for 6-month review target.","Type C meeting for ADX-2191 in PVR planned H1 2023; Phase 2 results in retinitis pigmentosa expected H1 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0001157523-22-001777","json":"https://secwatch.observer/filing/0001157523-22-001777.json","markdown":"https://secwatch.observer/filing/0001157523-22-001777.md","text":"https://secwatch.observer/filing/0001157523-22-001777.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1341235/000115752322001777/0001157523-22-001777-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1341235/000115752322001777/a53110252.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-21T00:43:52.725586+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"}