{"schema_version":"secwatch.filing_event.v1","accession":"0001157523-22-001698","form_type":"8-K","ticker":"ALDX","cik":"0001341235","company_name":"Aldeyra Therapeutics, Inc.","filed_at":"2022-12-01T23:59:59+00:00","discovered_at":"2026-05-14T18:03:50.274680+00:00","generated_at":"2026-06-21T10:44:53.727625+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Aldeyra announces positive FDA pre-NDA meeting for ADX-2191; NDA submission expected by end of 2022","bullets":["Pre-NDA meeting with FDA concluded positively; NDA for ADX-2191 in primary vitreoretinal lymphoma planned as soon as end of 2022.","Company intends to request Priority Review, which would shorten FDA review to 6 months.","ADX-2191 has Orphan Drug Designation; Phase 3 GUARD Trial showed no serious adverse events and was well tolerated.","Most common adverse event was punctate keratitis, less frequent than previously reported with compounded methotrexate.","Type C meeting for proliferative vitreoretinopathy and Phase 2 retinitis pigmentosa results expected in first half of 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0001157523-22-001698","json":"https://secwatch.observer/filing/0001157523-22-001698.json","markdown":"https://secwatch.observer/filing/0001157523-22-001698.md","text":"https://secwatch.observer/filing/0001157523-22-001698.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1341235/000115752322001698/0001157523-22-001698-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1341235/000115752322001698/a52993162.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-21T10:44:53.727625+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"}