{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-25-054949","form_type":"8-K","ticker":"ALDX","cik":"0001341235","company_name":"Aldeyra Therapeutics, Inc.","filed_at":"2025-06-17T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.022807+00:00","generated_at":"2026-05-19T04:25:47.287999+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Aldeyra resubmits reproxalap NDA for dry eye disease after CRL, Phase 3 trial met primary endpoint","bullets":["Resubmitted NDA to FDA for topical ocular reproxalap to treat signs and symptoms of dry eye disease.","Earlier CRL in April 2025 cited potential methodological issues; new Phase 3 dry eye chamber trial achieved primary endpoint (P=0.002).","No notable baseline differences across treatment arms; mild transient instillation site discomfort was most common AE.","PDUFA goal: FDA acceptance decision within 30 days, review completion within 6 months of submission."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-25-054949","json":"https://secwatch.observer/filing/0001213900-25-054949.json","markdown":"https://secwatch.observer/filing/0001213900-25-054949.md","text":"https://secwatch.observer/filing/0001213900-25-054949.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1341235/000121390025054949/0001213900-25-054949-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1341235/000121390025054949/ea0245870-8k_aldeyra.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-19T04:25:47.287999+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"}