{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-453537","form_type":"8-K","ticker":"ALDX","cik":"0001341235","company_name":"Aldeyra Therapeutics, Inc.","filed_at":"2026-11-09T21:02:19+00:00","discovered_at":"2026-11-09T21:03:00.297494+00:00","generated_at":"2026-11-09T21:03:10.588592+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Aldeyra seeks FDA transfer of ADX-2191 PVRL review, withdraws SPA protocol","bullets":["Aldeyra asked FDA's Division of Ophthalmology to submit a jurisdiction request to OND to move the ADX-2191 IND for PVRL to the Division of Hematologic Malignancies 2.","Company notified FDA it withdrew the Special Protocol Assessment protocol for ADX-2191 in PVRL that the Division of Ophthalmology had reviewed and agreed to.","Aldeyra does not expect to initiate the SPA-contemplated trial while the request is pending and expects the PVRL program will need to be redesigned.","Context: FDA issued a Complete Response Letter in June 2023 for the ADX-2191 PVRL NDA, citing lack of substantial evidence of effectiveness.","Company warns a redesign may be larger, longer and costlier, could delay orphan drug exclusivity, shorten cash runway and require raising capital sooner."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-453537","json":"https://secwatch.observer/filing/0001193125-26-453537.json","markdown":"https://secwatch.observer/filing/0001193125-26-453537.md","text":"https://secwatch.observer/filing/0001193125-26-453537.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1341235/000119312526453537/0001193125-26-453537-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1341235/000119312526453537/aldx-20261109.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-11-09T21:03:10.588592+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"}