{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-232717","form_type":"8-K","ticker":"PVLA","cik":"0001583648","company_name":"PALVELLA THERAPEUTICS, INC.","filed_at":"2026-05-20T20:35:15+00:00","discovered_at":"2026-05-20T20:36:00.253842+00:00","generated_at":"2026-05-20T20:36:52.256361+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 Phase 3 SELVA: 100% of children responded; NDA filing on track for H2 2026","bullets":["Phase 3 SELVA: 100% of 13 children (6-11 yrs) rated 'Much Improved' or better on mLM-IGA at Week 24 (mean +2.46, p<0.001).","87% (20/23) with baseline leaking/bleeding showed 'Much Improved' or better on leaking/bleeding scale at Week 24 (mean +2.48).","Blinded review: pre-treatment stability, then 48% max improvement after 24 weeks (mean mLM-MCSS from 9.9 to 6.6).","Phase 2 TOIVA: stat sig improvements in cVM-MCSS Height (mean -1.50) and Appearance (mean -1.43) at Week 24 (p<0.001).","NDA submission for microcystic LMs planned H2 2026; Phase 3 for cutaneous VMs starts H2 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-232717","json":"https://secwatch.observer/filing/0001193125-26-232717.json","markdown":"https://secwatch.observer/filing/0001193125-26-232717.md","text":"https://secwatch.observer/filing/0001193125-26-232717.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1583648/000119312526232717/0001193125-26-232717-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1583648/000119312526232717/pvla-20260520.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-20T20:36:52.256361+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"}