{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-092681","form_type":"8-K","ticker":"PVLA","cik":"0001583648","company_name":"PALVELLA THERAPEUTICS, INC.","filed_at":"2025-09-24T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.417189+00:00","generated_at":"2026-05-17T05:46:20.810441+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Palvella expands QTORIN rapamycin program into angiokeratomas, plans Phase 2 in H2 2026","bullets":["No FDA-approved therapies exist for clinically significant angiokeratomas, which affect >50,000 diagnosed U.S. patients.","Phase 2 trial of QTORIN rapamycin for angiokeratomas planned to start H2 2026; FDA meeting expected H1 2026.","Ongoing Phase 3 SELVA study for microcystic lymphatic malformations: top-line results Q1 2026; TOIVA Phase 2 results mid-Dec 2025.","Angiokeratomas recently classified as isolated lymphatic malformation by ISSVA in 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-092681","json":"https://secwatch.observer/filing/0001104659-25-092681.json","markdown":"https://secwatch.observer/filing/0001104659-25-092681.md","text":"https://secwatch.observer/filing/0001104659-25-092681.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1583648/000110465925092681/0001104659-25-092681-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1583648/000110465925092681/tm2526823d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T05:46:20.810441+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"}