{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-24-029514","form_type":"8-K","ticker":"PCSA","cik":"0001533743","company_name":"Processa Pharmaceuticals, Inc.","filed_at":"2024-07-30T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.420572+00:00","generated_at":"2026-05-31T15:16:32.365710+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"FDA clears IND for Processa's NGC-Cap Phase 2 trial in breast cancer","bullets":["FDA cleared IND for NGC-Cap Phase 2 trial in advanced/metastatic breast cancer.","Phase 2 trial enrollment expected to begin in Q3 2024.","Initial data from the Phase 2 trial expected mid-2025.","Phase 1b showed NGC-Cap provides 5-10x more 5-FU exposure and better safety than capecitabine alone.","Trial is global, open-label, adaptive design with 60-90 patients; compares two doses of NGC-Cap to capecitabine."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-24-029514","json":"https://secwatch.observer/filing/0001493152-24-029514.json","markdown":"https://secwatch.observer/filing/0001493152-24-029514.md","text":"https://secwatch.observer/filing/0001493152-24-029514.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1533743/000149315224029514/0001493152-24-029514-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1533743/000149315224029514/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T15:16:32.365710+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"}