{"filing":{"accession_number":"0001193125-26-405954","cik":"0001341235","ticker":"ALDX","company_name":"Aldeyra Therapeutics, Inc.","form":"8-K","filing_date":"2026-09-29","report_date":"2026-09-29","primary_document":"aldx-20260929.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1341235/000119312526405954/aldx-20260929.htm"},"events":[{"id":35579,"run_id":32778,"accession_number":"0001193125-26-405954","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"Aldeyra disclosed its intent to submit a Formal Dispute Resolution Request (FDRR) to the FDA's Office of New Drugs to appeal a Complete Response Letter denying approval of reproxalap for dry eye disease, along with an extension of projected operational cash runway into 2029. This represents a material strategic and regulatory development as the FDRR is a significant pathway to challenge the FDA's rejection of the company's lead product candidate.","company_name":"Aldeyra Therapeutics, Inc.","ticker":"ALDX","filing_date":"2026-09-29","form":"8-K","submitted_at":null,"items":[{"id":39672,"accession_number":"0001193125-26-405954","item_number":"7.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Aldeyra disclosed its intent to submit a Formal Dispute Resolution Request (FDRR) to the FDA's Office of New Drugs appealing a Complete Response Letter that denied approval of reproxalap for dry eye disease, along with an extension of operational cash runway into 2029. This is a material regulatory and strategic development—the FDRR represents a significant pathway to challenge the FDA's rejection and is central to the company's near-term prospects. While the disclosure involves regulatory interaction, it is fundamentally an operational/strategic decision to pursue dispute resolution rather than a discrete regulatory event like a delisting or going-concern issue. The cash runway extension is also operationally significant but secondary to the FDRR announcement.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-29T11:02:42.063605+00:00","company_name":"","ticker":null,"filing_date":""},{"id":39673,"accession_number":"0001193125-26-405954","item_number":"8.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Aldeyra disclosed its intent to submit a Formal Dispute Resolution Request (FDRR) to the FDA challenging a Complete Response Letter that denied approval of reproxalap for dry eye disease, along with an extension of projected operational cash runway into 2029. This is a material regulatory and strategic development—the company is appealing an FDA rejection of its lead product candidate through an established but uncertain dispute process. While the filing involves regulatory interaction, the core disclosure centers on the company's strategic decision to pursue the FDRR appeal and its cash position, making this an operational/strategic milestone rather than a specific financial, governance, or legal event type.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-29T11:02:42.063605+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":39672,"accession_number":"0001193125-26-405954","item_number":"7.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Aldeyra disclosed its intent to submit a Formal Dispute Resolution Request (FDRR) to the FDA's Office of New Drugs appealing a Complete Response Letter that denied approval of reproxalap for dry eye disease, along with an extension of operational cash runway into 2029. This is a material regulatory and strategic development—the FDRR represents a significant pathway to challenge the FDA's rejection and is central to the company's near-term prospects. While the disclosure involves regulatory interaction, it is fundamentally an operational/strategic decision to pursue dispute resolution rather than a discrete regulatory event like a delisting or going-concern issue. The cash runway extension is also operationally significant but secondary to the FDRR announcement.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-29T11:02:42.063605+00:00","company_name":"Aldeyra Therapeutics, Inc.","ticker":"ALDX","filing_date":"2026-09-29"},{"id":39673,"accession_number":"0001193125-26-405954","item_number":"8.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Aldeyra disclosed its intent to submit a Formal Dispute Resolution Request (FDRR) to the FDA challenging a Complete Response Letter that denied approval of reproxalap for dry eye disease, along with an extension of projected operational cash runway into 2029. This is a material regulatory and strategic development—the company is appealing an FDA rejection of its lead product candidate through an established but uncertain dispute process. While the filing involves regulatory interaction, the core disclosure centers on the company's strategic decision to pursue the FDRR appeal and its cash position, making this an operational/strategic milestone rather than a specific financial, governance, or legal event type.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-29T11:02:42.063605+00:00","company_name":"Aldeyra Therapeutics, Inc.","ticker":"ALDX","filing_date":"2026-09-29"}]}