{"filing":{"accession_number":"0001104659-26-107273","cik":"0001727196","ticker":"SRRK","company_name":"Scholar Rock Holding Corp","form":"8-K","filing_date":"2026-09-14","report_date":"2026-09-11","primary_document":"tm2625362d1_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1727196/000110465926107273/tm2625362d1_8k.htm"},"events":[{"id":33139,"run_id":30464,"accession_number":"0001104659-26-107273","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"Scholar Rock announced FDA approval of ISEMBYLD (apitegromab-mstn) for treating spinal muscular atrophy in adults and children 2+ years old receiving SMN2-targeted therapy. This represents a major regulatory and commercial milestone—the first muscle-targeted treatment for SMA—with immediate U.S. commercial launch underway.","company_name":"Scholar Rock Holding Corp","ticker":"SRRK","filing_date":"2026-09-14","form":"8-K","submitted_at":null,"items":[{"id":36500,"accession_number":"0001104659-26-107273","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Scholar Rock announced FDA approval of ISEMBYLD (apitegromab-mstn) for treating spinal muscular atrophy, marking a major regulatory and commercial milestone. While this is a significant operational and strategic event for the biopharmaceutical company—involving product approval, commercial launch, and market access—it does not fit neatly into the predefined event categories. The disclosure centers on a regulatory approval and product launch milestone rather than earnings, M\u0026A, executive changes, or financial obligations. This is material to investors as it represents a transformative regulatory achievement and the beginning of commercial operations for the company's lead product.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-14T12:03:06.843969+00:00","company_name":"","ticker":null,"filing_date":""},{"id":36501,"accession_number":"0001104659-26-107273","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Scholar Rock announced FDA approval of ISEMBYLD (apitegromab-mstn) for treating spinal muscular atrophy in adults and children 2+ years old receiving SMN2-targeted therapy. This is a major regulatory and commercial milestone—the first muscle-targeted treatment for SMA—with immediate U.S. commercial launch underway. While this is a transformative product approval and business event, it does not fit neatly into the predefined financial, governance, or legal categories; it is fundamentally an operational/strategic milestone reflecting successful drug development and regulatory clearance, making operational_other the most appropriate classification.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-14T12:03:06.843969+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":36500,"accession_number":"0001104659-26-107273","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Scholar Rock announced FDA approval of ISEMBYLD (apitegromab-mstn) for treating spinal muscular atrophy, marking a major regulatory and commercial milestone. While this is a significant operational and strategic event for the biopharmaceutical company—involving product approval, commercial launch, and market access—it does not fit neatly into the predefined event categories. The disclosure centers on a regulatory approval and product launch milestone rather than earnings, M\u0026A, executive changes, or financial obligations. This is material to investors as it represents a transformative regulatory achievement and the beginning of commercial operations for the company's lead product.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-14T12:03:06.843969+00:00","company_name":"Scholar Rock Holding Corp","ticker":"SRRK","filing_date":"2026-09-14"},{"id":36501,"accession_number":"0001104659-26-107273","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Scholar Rock announced FDA approval of ISEMBYLD (apitegromab-mstn) for treating spinal muscular atrophy in adults and children 2+ years old receiving SMN2-targeted therapy. This is a major regulatory and commercial milestone—the first muscle-targeted treatment for SMA—with immediate U.S. commercial launch underway. While this is a transformative product approval and business event, it does not fit neatly into the predefined financial, governance, or legal categories; it is fundamentally an operational/strategic milestone reflecting successful drug development and regulatory clearance, making operational_other the most appropriate classification.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-14T12:03:06.843969+00:00","company_name":"Scholar Rock Holding Corp","ticker":"SRRK","filing_date":"2026-09-14"}]}