{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-204389","form_type":"8-K","ticker":"CRBP","cik":"0001595097","company_name":"Corbus Pharmaceuticals Holdings, Inc.","filed_at":"2025-09-16T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.454497+00:00","generated_at":"2026-05-17T06:30:00.960263+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"FDA grants Fast Track designation for Corbus' CRB-701 in recurrent/metastatic HNSCC","bullets":["FDA granted Fast Track for CRB-701 to treat HNSCC after prior platinum and anti-PD(L)-1 therapy.","Second Fast Track designation for CRB-701; first was for cervical cancer in December 2024.","Phase 1/2 dose optimization data to be presented at ESMO 2025 on October 19, 2025.","CRB-701 is a next-generation Nectin-4 targeting ADC with site-specific cleavable linker and MMAE payload (DAR 2).","Ongoing Phase 1/2 trial evaluating safety, PK, and efficacy in advanced solid tumors with high Nectin-4 expression."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-204389","json":"https://secwatch.observer/filing/0001193125-25-204389.json","markdown":"https://secwatch.observer/filing/0001193125-25-204389.md","text":"https://secwatch.observer/filing/0001193125-25-204389.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1595097/000119312525204389/0001193125-25-204389-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1595097/000119312525204389/crbp-20250916.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T06:30:00.960263+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"}