{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-072424","form_type":"8-K","ticker":"ALDX","cik":"0001341235","company_name":"Aldeyra Therapeutics, Inc.","filed_at":"2025-04-03T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.022004+00:00","generated_at":"2026-05-23T22:22:37.049542+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FDA issues Complete Response Letter for Aldeyra's reproxalap dry eye NDA; additional study required","bullets":["FDA CRL states reproxalap 'failed to demonstrate efficacy' in adequate studies; no safety or manufacturing issues.","Type A meeting expected within ~30 days; top-line data from ongoing chamber and field trials due Q2 2025.","Aldeyra plans NDA resubmission mid-2025 pending positive results and FDA discussions; review period expected 6 months.","Cash, equivalents, and marketable securities $101M as of Dec 31, 2024; 2025 trial costs ~$6M."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-072424","json":"https://secwatch.observer/filing/0001193125-25-072424.json","markdown":"https://secwatch.observer/filing/0001193125-25-072424.md","text":"https://secwatch.observer/filing/0001193125-25-072424.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1341235/000119312525072424/0001193125-25-072424-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1341235/000119312525072424/d946200d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-23T22:22:37.049542+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"}