{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-23-045362","form_type":"8-K","ticker":"PCSA","cik":"0001533743","company_name":"Processa Pharmaceuticals, Inc.","filed_at":"2023-12-19T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.407474+00:00","generated_at":"2026-06-07T10:32:17.246263+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Processa Pharma: Phase 1b interim data show NGC-Cap improved safety with 10x higher 5-FU exposure than capecitabine","bullets":["NGC-Cap doses: 75-225 mg twice daily vs capecitabine's 1600-2500 mg twice daily; 5-FU exposure up to 10x greater.","Anabolite side effect profile similar to capecitabine; FBAL-related side effects (hand-foot syndrome) almost absent; FBAL exposure ~1% of capecitabine.","FDA acknowledges NGC-Cap as a New Chemical Entity based on altered metabolism and distribution of 5-FU.","Fireside chat scheduled Dec 20 at 4:30 PM ET to discuss data and corporate strategy; results require further studies."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-23-045362","json":"https://secwatch.observer/filing/0001493152-23-045362.json","markdown":"https://secwatch.observer/filing/0001493152-23-045362.md","text":"https://secwatch.observer/filing/0001493152-23-045362.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1533743/000149315223045362/0001493152-23-045362-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1533743/000149315223045362/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T10:32:17.246263+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"}