{"filing":{"accession_number":"0001104659-26-106190","cik":"0001768946","ticker":null,"company_name":"Biophytis SA","form":"6-K","filing_date":"2026-09-09","report_date":"2026-09-09","primary_document":"tm2625095d1_6k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1768946/000110465926106190/tm2625095d1_6k.htm"},"events":[{"id":32286,"run_id":29663,"accession_number":"0001104659-26-106190","anchor_item_number":"EX-99.1","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"summary":"Biophytis announced a protocol amendment to its Phase 2 OBA clinical study, expanding the evaluation of BIO101 to assess its potential to limit weight regain (\"rebound effect\") following semaglutide discontinuation. The amendment has been submitted to ANVISA (Brazil) with planned submissions to the FDA and EMA. This represents a material expansion of the clinical development scope for the company's lead drug candidate in obesity, a key indication under its licensing agreement with Blanver (worth up to €108 million). The amendment is operational and strategic in nature—affecting the clinical trial design and regulatory pathway—rather than a discrete event type like M\u0026A, litigation, or financial reporting.","company_name":"Biophytis SA","ticker":null,"filing_date":"2026-09-09","form":"6-K","submitted_at":null,"items":[{"id":35431,"accession_number":"0001104659-26-106190","item_number":"EX-99.1","item_title":"tm2625095d1_ex99-1.htm","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"Biophytis announced a protocol amendment to its Phase 2 OBA clinical study, expanding the evaluation of BIO101 to assess its potential to limit weight regain (\"rebound effect\") following semaglutide discontinuation. The amendment has been submitted to ANVISA (Brazil) with planned submissions to the FDA and EMA. This represents a material expansion of the clinical development scope for the company's lead drug candidate in obesity, a key indication under its licensing agreement with Blanver (worth up to €108 million). The amendment is operational and strategic in nature—affecting the clinical trial design and regulatory pathway—rather than a discrete event type like M\u0026A, litigation, or financial reporting.","classifier_version":"claude-haiku-4-5-20251001+prompt-6be895f9","taxonomy_version":"v1.3","classified_at":"2026-09-09T14:48:54.540870+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":35431,"accession_number":"0001104659-26-106190","item_number":"EX-99.1","item_title":"tm2625095d1_ex99-1.htm","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"Biophytis announced a protocol amendment to its Phase 2 OBA clinical study, expanding the evaluation of BIO101 to assess its potential to limit weight regain (\"rebound effect\") following semaglutide discontinuation. The amendment has been submitted to ANVISA (Brazil) with planned submissions to the FDA and EMA. This represents a material expansion of the clinical development scope for the company's lead drug candidate in obesity, a key indication under its licensing agreement with Blanver (worth up to €108 million). The amendment is operational and strategic in nature—affecting the clinical trial design and regulatory pathway—rather than a discrete event type like M\u0026A, litigation, or financial reporting.","classifier_version":"claude-haiku-4-5-20251001+prompt-6be895f9","taxonomy_version":"v1.3","classified_at":"2026-09-09T14:48:54.540870+00:00","company_name":"Biophytis SA","ticker":null,"filing_date":"2026-09-09"}]}
