{"filing":{"accession_number":"0001654954-26-007798","cik":"0001131399","ticker":"GLAXF","company_name":"GSK plc","form":"6-K","filing_date":"2026-08-24","report_date":"2026-08-24","primary_document":"a7607r.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1131399/000165495426007798/a7607r.htm"},"events":[{"id":29029,"run_id":26561,"accession_number":"0001654954-26-007798","anchor_item_number":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"summary":"GSK announced that the US FDA has accepted for priority review a supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) for locally advanced rectal cancer, with a PDUFA action date of February 2027. The announcement discloses positive interim data from the AZUR-1 trial showing sustained clinical complete responses and the potential for dostarlimab to eliminate the need for chemotherapy, radiation, and surgery for some patients. This is a material regulatory milestone and product development event that would affect a reasonable investor's assessment of GSK's pipeline and commercial prospects, but it does not fit neatly into the specific event categories (it is not an earnings release, M\u0026A activity, executive change, or other named event type); accordingly, it is classified as an operational/strategic business milestone.","company_name":"GSK plc","ticker":"GLAXF","filing_date":"2026-08-24","form":"6-K","submitted_at":null,"items":null}],"classifications":[{"id":31168,"accession_number":"0001654954-26-007798","item_number":null,"item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"GSK announced that the US FDA has accepted for priority review a supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) for locally advanced rectal cancer, with a PDUFA action date of February 2027. The announcement discloses positive interim data from the AZUR-1 trial showing sustained clinical complete responses and the potential for dostarlimab to eliminate the need for chemotherapy, radiation, and surgery for some patients. This is a material regulatory milestone and product development event that would affect a reasonable investor's assessment of GSK's pipeline and commercial prospects, but it does not fit neatly into the specific event categories (it is not an earnings release, M\u0026A activity, executive change, or other named event type); accordingly, it is classified as an operational/strategic business milestone.","classifier_version":"claude-haiku-4-5-20251001+prompt-6be895f9","taxonomy_version":"v1.3","classified_at":"2026-08-24T10:21:49.121211+00:00","company_name":"GSK plc","ticker":"GLAXF","filing_date":"2026-08-24"}]}