{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-109932","form_type":"8-K","ticker":"ALDX","cik":"0001341235","company_name":"Aldeyra Therapeutics, Inc.","filed_at":"2025-08-19T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.778712+00:00","generated_at":"2026-05-17T11:22:55.746260+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Aldeyra receives FDA Fast Track Designation for ADX-2191 in retinitis pigmentosa","bullets":["FDA granted Fast Track Designation for ADX-2191 (methotrexate intravitreal injection) for retinitis pigmentosa.","No approved therapy exists for most forms of retinitis pigmentosa, which affects over 1 million people worldwide.","Fast Track complements prior Orphan Drug Designation; may allow rolling review or priority/accelerated approval.","Phase 2/3 trial of ADX-2191 in retinitis pigmentosa expected to start in 2025.","Phase 2 results (2023) showed improvements from baseline in retinal sensitivity."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-109932","json":"https://secwatch.observer/filing/0000950170-25-109932.json","markdown":"https://secwatch.observer/filing/0000950170-25-109932.md","text":"https://secwatch.observer/filing/0000950170-25-109932.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1341235/000095017025109932/0000950170-25-109932-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1341235/000095017025109932/aldx-20250819.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T11:22:55.746260+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"}