{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-319638","form_type":"8-K","ticker":"ALDX","cik":"0001341235","company_name":"Aldeyra Therapeutics, Inc.","filed_at":"2025-12-16T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.192826+00:00","generated_at":"2026-05-16T13:01:02.182011+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Aldeyra: FDA extends reproxalap PDUFA to March 16, 2026 after requesting failed trial report","bullets":["PDUFA target action date extended three months to March 16, 2026 from original Dec 16, 2025.","FDA requested CSR of dry eye field trial that missed primary endpoint; CSR submitted Dec 12 as major amendment.","FDA shared draft label in early December; Aldeyra responded; labeling and postmarketing plans expected by Feb 16, 2026.","No other specific issues or requests identified by FDA during review.","Field trial top-line results announced May 5, 2025; safety data previously submitted Aug 21, 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-319638","json":"https://secwatch.observer/filing/0001193125-25-319638.json","markdown":"https://secwatch.observer/filing/0001193125-25-319638.md","text":"https://secwatch.observer/filing/0001193125-25-319638.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1341235/000119312525319638/0001193125-25-319638-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1341235/000119312525319638/aldx-20251215.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T13:01:02.182011+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"}