{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-283679","form_type":"8-K","ticker":"ALDX","cik":"0001341235","company_name":"Aldeyra Therapeutics, Inc.","filed_at":"2023-11-28T23:59:59+00:00","discovered_at":"2026-05-14T18:03:28.705493+00:00","generated_at":"2026-06-07T20:53:44.589808+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":"FDA issues Complete Response Letter for reproxalap NDA in dry eye disease; additional trial required","bullets":["FDA CRL states NDA did not demonstrate efficacy on ocular symptoms; requires at least one additional adequate and well-controlled study.","No safety or manufacturing issues identified.","Aldeyra submitted SPA for chamber crossover trial on Nov 16; expects FDA feedback in Dec 2023.","Proposed trial cost <$2M, top-line results expected H1 2024; potential NDA resubmission in H1 2024.","Cash runway extended to late 2025, with $143M cash as of Sep 30, 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-283679","json":"https://secwatch.observer/filing/0001193125-23-283679.json","markdown":"https://secwatch.observer/filing/0001193125-23-283679.md","text":"https://secwatch.observer/filing/0001193125-23-283679.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1341235/000119312523283679/0001193125-23-283679-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1341235/000119312523283679/d723036d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T20:53:44.589808+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"}