{"schema_version":"secwatch.filing_event.v1","accession":"0001157523-23-001018","form_type":"8-K","ticker":"ALDX","cik":"0001341235","company_name":"Aldeyra Therapeutics, Inc.","filed_at":"2023-06-21T23:59:59+00:00","discovered_at":"2026-05-14T18:03:38.506693+00:00","generated_at":"2026-06-13T19:50:15.894900+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA issues Complete Response Letter for Aldeyra's ADX-2191 NDA for PVRL","bullets":["FDA cited lack of substantial evidence due to no adequate well-controlled studies in literature-based NDA.","No safety or manufacturing issues identified in the Complete Response Letter.","Aldeyra plans Expanded Access Program discussions with FDA due to methotrexate shortage and no approved PVRL therapy.","ADX-2191 also under development for proliferative vitreoretinopathy and retinitis pigmentosa.","Top-line Phase 2 results in retinitis pigmentosa expected to be announced June 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0001157523-23-001018","json":"https://secwatch.observer/filing/0001157523-23-001018.json","markdown":"https://secwatch.observer/filing/0001157523-23-001018.md","text":"https://secwatch.observer/filing/0001157523-23-001018.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1341235/000115752323001018/0001157523-23-001018-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1341235/000115752323001018/a53427165.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T19:50:15.894900+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"}