{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-454423","form_type":"8-K","ticker":"SRRK","cik":"0001727196","company_name":"Scholar Rock Holding Corp","filed_at":"2026-11-10T12:10:18+00:00","discovered_at":"2026-11-10T12:15:00.236227+00:00","generated_at":"2026-11-10T12:15:05.014098+00:00","sec_items":["1.01","2.02","7.01","9.01"],"event_type":"m_and_a","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Scholar Rock to sell PRV to BioNTech for $205M; Q3 EPS loss $0.81, first ISEMBYLD revenue $0.6M","bullets":["Definitive PRV asset purchase agreement signed Nov 9, 2026 with BioNTech US Inc.; $205M in cash payable at closing, subject to HSR waiting-period expiration.","Q3 2026 net loss $107.2M ($0.81 per share) vs $102.2M ($0.90 per share) a year earlier; net product revenue of $0.6M from ISEMBYLD after Sept 11 FDA approval.","Cash, cash equivalents and marketable securities of $413.6M at Sept 30, 2026; R&D $54.1M, SG&A $52.5M, stock-based compensation $17.9M.","EMA validated the apitegromab MAA resubmission in October 2026, with CHMP opinion expected H1 2027; Japanese JNDA accepted under priority review (~9-month cycle).","SRK-439 Phase 1 topline data expected by year-end 2026; FSHD FORGE Phase 2 enrolling ~60 patients; FDA granted Fast Track and Orphan Drug designations in September 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-454423","json":"https://secwatch.observer/filing/0001193125-26-454423.json","markdown":"https://secwatch.observer/filing/0001193125-26-454423.md","text":"https://secwatch.observer/filing/0001193125-26-454423.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1727196/000119312526454423/0001193125-26-454423-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1727196/000119312526454423/srrk-20261110.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-11-10T12:15:05.014098+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}