{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-25-058035","form_type":"8-K","ticker":"ALDX","cik":"0001341235","company_name":"Aldeyra Therapeutics, Inc.","filed_at":"2025-06-26T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.023068+00:00","generated_at":"2026-05-18T17:40:03.905823+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Aldeyra receives FDA Special Protocol Assessment for ADX-2191 in primary vitreoretinal lymphoma","bullets":["SPA agreement provides FDA alignment on clinical trial design for ADX-2191 (methotrexate injection) to treat PVRL, a rare and fatal cancer with no approved therapy.","Trial will randomize up to 20 patients 1:1 to a single intravitreal injection vs. eight injections; primary endpoint is cancer cell clearance at 30 days.","Trial expected to start H2 2025 and conclude in 2026; positive SPA may support NDA resubmission with one adequate and well-controlled study plus literature.","Prior NDA for ADX-2191 received a Complete Response Letter in June 2023 due to insufficient literature-based efficacy evidence.","ADX-2191 is a novel, vitreous-compatible methotrexate formulation designed for intraocular injection potentially reducing injection volume vs. compounded methotrexate."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-25-058035","json":"https://secwatch.observer/filing/0001213900-25-058035.json","markdown":"https://secwatch.observer/filing/0001213900-25-058035.md","text":"https://secwatch.observer/filing/0001213900-25-058035.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1341235/000121390025058035/0001213900-25-058035-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1341235/000121390025058035/ea0247000-8k_aldeyra.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T17:40:03.905823+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"}