{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-065159","form_type":"8-K","ticker":"PVLA","cik":"0001583648","company_name":"PALVELLA THERAPEUTICS, INC.","filed_at":"2026-02-24T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.534913+00:00","generated_at":"2026-05-16T00:48:11.917776+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Palvella Phase 3 SELVA study of QTORIN rapamycin meets primary endpoint with p<0.001; NDA planned H2 2026","bullets":["Primary endpoint achieved: mean +2.13 improvement on mLM-IGA (p<0.001); all secondary endpoints met (p<0.001).","86% of completers rated 'Much Improved' or better; 95% improved at least 1 point.","Well-tolerated: no drug-related SAEs; systemic rapamycin levels <2 ng/mL at all timepoints.","NDA submission to FDA planned H2 2026; potential approval H1 2027 for first approved therapy for microcystic LMs.","98% of eligible participants chose to continue in extension period."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-065159","json":"https://secwatch.observer/filing/0001193125-26-065159.json","markdown":"https://secwatch.observer/filing/0001193125-26-065159.md","text":"https://secwatch.observer/filing/0001193125-26-065159.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1583648/000119312526065159/0001193125-26-065159-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1583648/000119312526065159/pvla-20260224.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T00:48:11.917776+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"}