{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-26-065408","form_type":"8-K","ticker":"VIR","cik":"0001706431","company_name":"Vir Biotechnology, Inc.","filed_at":"2026-10-08T12:38:38+00:00","discovered_at":"2026-10-08T12:40:00.299088+00:00","generated_at":"2026-10-12T15:36:14.710801+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Vir Biotechnology's VIR-5500 wins FDA Fast Track in late-line mCRPC; Phase 3 set for 2027","bullets":["FDA granted Fast Track designation to VIR-5500, a PSMA-targeted PRO-XTEN dual-masked T-cell engager, for late-line metastatic castration-resistant prostate cancer (mCRPC).","VIR-5500 is co-developed with Astellas Pharma Inc. under a global strategic collaboration; pivotal Phase 3 development is anticipated to begin in 2027.","Phase 1 study spans six dose-expansion cohorts: monotherapy in taxane-naive, radioligand therapy-naive and radioligand-exposed mCRPC.","Combination cohorts test VIR-5500 with enzalutamide or docetaxel in early-line mCRPC, and with darolutamide in metastatic hormone-sensitive prostate cancer (mHSPC).","Earlier 2026 Phase 1 data showed VIR-5500 was generally well tolerated with promising anti-tumor activity in mCRPC patients, per CEO Marianne De Backer."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-26-065408","json":"https://secwatch.observer/filing/0001628280-26-065408.json","markdown":"https://secwatch.observer/filing/0001628280-26-065408.md","text":"https://secwatch.observer/filing/0001628280-26-065408.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1706431/000162828026065408/0001628280-26-065408-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1706431/000162828026065408/vir-20261008.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T15:36:14.710801+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"}