{"schema_version":"secwatch.filing_event.v1","accession":"0001753926-25-000211","form_type":"8-K","ticker":"LIPO","cik":"0001347242","company_name":"LIPELLA PHARMACEUTICALS INC.","filed_at":"2025-02-11T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.405174+00:00","generated_at":"2026-05-26T23:17:36.955610+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Lipella reports positive Phase 2a results for LP-310 in oral lichen planus; FDA okays expanded access","bullets":["FDA approved Expanded Access Program for LP-310 (oral rinse for OLP) on Feb 6, 2025.","Phase 2a topline: statistically significant improvements in pain (NRS), IGA, REU, and OLPSSM at weeks 1, 4, 6.","No product-related SAEs, no dropouts; tacrolimus blood levels undetectable or minimal in all patients.","Trial advancing to 0.5 mg dose cohort; recruitment to conclude first half 2025.","Company plans Phase 2b IND submission and Breakthrough Therapy request in second half 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001753926-25-000211","json":"https://secwatch.observer/filing/0001753926-25-000211.json","markdown":"https://secwatch.observer/filing/0001753926-25-000211.md","text":"https://secwatch.observer/filing/0001753926-25-000211.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1347242/000175392625000211/0001753926-25-000211-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1347242/000175392625000211/g084697_8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-26T23:17:36.955610+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"}