{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-225317","form_type":"8-K","ticker":"PVLA","cik":"0001583648","company_name":"PALVELLA THERAPEUTICS, INC.","filed_at":"2026-05-15T11:30:16+00:00","discovered_at":"2026-05-15T11:35:00.312863+00:00","generated_at":"2026-05-15T11:35:25.409851+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Palvella reports Phase 2 TOIVA data: 100% bleed improvement, p=0.003","bullets":["100% of patients with bleeding at baseline showed statistically significant improvement on cVM-IGA Bleeding at Week 12 (mean +2.5, p=0.003).","All bleeding patients reported 'satisfied' or 'very satisfied' with QTORIN rapamycin on Treatment Satisfaction Questionnaire at Week 12.","Baseline patient interviews show QoL burden includes pain, physical limitations, emotional distress from lesion visibility.","QTORIN rapamycin could become first FDA-approved therapy for cutaneous venous malformations, targeting >75,000 U.S. patients.","Data presented at 83rd SID Annual Meeting in Chicago on May 15, 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-225317","json":"https://secwatch.observer/filing/0001193125-26-225317.json","markdown":"https://secwatch.observer/filing/0001193125-26-225317.md","text":"https://secwatch.observer/filing/0001193125-26-225317.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1583648/000119312526225317/0001193125-26-225317-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1583648/000119312526225317/pvla-20260515.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T11:35:25.409851+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"}