{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-109511","form_type":"8-K","ticker":"ALDX","cik":"0001341235","company_name":"Aldeyra Therapeutics, Inc.","filed_at":"2026-03-17T23:59:59+00:00","discovered_at":"2026-05-14T18:02:34.884942+00:00","generated_at":"2026-05-15T10:16:45.870813+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA issues second Complete Response Letter for Aldeyra's reproxalap NDA; efficacy concerns cited","bullets":["CRL states 'lack of substantial evidence' and 'failed to demonstrate efficacy' for dry eye disease signs and symptoms.","No safety or manufacturing concerns identified; FDA did not recommend additional trials or confirmatory evidence.","Aldeyra intends to request Type A meeting within 30 days to determine next steps for approval.","Cash and marketable securities of $70M as of Dec 31, 2025 expected to fund operations into 2028."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-109511","json":"https://secwatch.observer/filing/0001193125-26-109511.json","markdown":"https://secwatch.observer/filing/0001193125-26-109511.md","text":"https://secwatch.observer/filing/0001193125-26-109511.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1341235/000119312526109511/0001193125-26-109511-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1341235/000119312526109511/aldx-20260317.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T10:16:45.870813+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"}