{"filing":{"accession_number":"0001398733-26-000035","cik":"0001398733","ticker":"AQST","company_name":"Aquestive Therapeutics, Inc.","form":"8-K","filing_date":"2026-08-10","report_date":"2026-08-10","primary_document":"aqst-20260810.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1398733/000139873326000035/aqst-20260810.htm"},"events":[{"id":26340,"run_id":23931,"accession_number":"0001398733-26-000035","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"Aquestive disclosed positive topline results from human factors validation and pharmacokinetic studies for its investigational drug Anaphylm, directly addressing FDA concerns from a Complete Response Letter and supporting a planned NDA resubmission to the FDA in Q3 2026. These study results represent a material clinical and regulatory milestone for the company's lead product candidate and are critical to its path toward regulatory approval.","company_name":"Aquestive Therapeutics, Inc.","ticker":"AQST","filing_date":"2026-08-10","form":"8-K","submitted_at":null,"items":[{"id":27429,"accession_number":"0001398733-26-000035","item_number":"7.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Aquestive disclosed positive topline results from human factors and pharmacokinetic studies for its investigational drug Anaphylm, supporting a planned NDA resubmission to the FDA in Q3 2026. This is a material operational/clinical milestone for a pharmaceutical company's lead product candidate, demonstrating progress toward regulatory approval and commercial viability. While the Item 7.01 disclosure itself is a Regulation FD investor presentation, the substantive event disclosed—successful study results addressing FDA concerns from a Complete Response Letter—is material to investors' assessment of the company's prospects and pipeline advancement.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-10T11:07:02.857196+00:00","company_name":"","ticker":null,"filing_date":""},{"id":27430,"accession_number":"0001398733-26-000035","item_number":"8.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Aquestive announced positive topline results from human factors validation and pharmacokinetic studies for its investigational drug Anaphylm™, conducted to support a planned NDA resubmission to the FDA in Q3 2026. This is a material operational/regulatory milestone for a clinical-stage pharmaceutical company—the study results directly address FDA concerns from a Complete Response Letter and are critical to the company's path toward regulatory approval of a lead product candidate. While not a traditional earnings release, M\u0026A activity, or governance event, this disclosure of significant clinical study results supporting a major regulatory filing represents a material operational development that would affect a reasonable investor's assessment of the company's prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-10T11:07:02.857196+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":27429,"accession_number":"0001398733-26-000035","item_number":"7.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Aquestive disclosed positive topline results from human factors and pharmacokinetic studies for its investigational drug Anaphylm, supporting a planned NDA resubmission to the FDA in Q3 2026. This is a material operational/clinical milestone for a pharmaceutical company's lead product candidate, demonstrating progress toward regulatory approval and commercial viability. While the Item 7.01 disclosure itself is a Regulation FD investor presentation, the substantive event disclosed—successful study results addressing FDA concerns from a Complete Response Letter—is material to investors' assessment of the company's prospects and pipeline advancement.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-10T11:07:02.857196+00:00","company_name":"Aquestive Therapeutics, Inc.","ticker":"AQST","filing_date":"2026-08-10"},{"id":27430,"accession_number":"0001398733-26-000035","item_number":"8.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Aquestive announced positive topline results from human factors validation and pharmacokinetic studies for its investigational drug Anaphylm™, conducted to support a planned NDA resubmission to the FDA in Q3 2026. This is a material operational/regulatory milestone for a clinical-stage pharmaceutical company—the study results directly address FDA concerns from a Complete Response Letter and are critical to the company's path toward regulatory approval of a lead product candidate. While not a traditional earnings release, M\u0026A activity, or governance event, this disclosure of significant clinical study results supporting a major regulatory filing represents a material operational development that would affect a reasonable investor's assessment of the company's prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-10T11:07:02.857196+00:00","company_name":"Aquestive Therapeutics, Inc.","ticker":"AQST","filing_date":"2026-08-10"}]}