{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-435113","form_type":"8-K","ticker":"PVLA","cik":"0001583648","company_name":"PALVELLA THERAPEUTICS, INC.","filed_at":"2026-10-28T11:30:13+00:00","discovered_at":"2026-10-28T11:35:00.249977+00:00","generated_at":"2026-10-28T11:35:19.344817+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA accepts Palvella's QTORIN rapamycin NDA with Priority Review; PDUFA date Feb 28, 2027","bullets":["FDA accepted for filing and granted Priority Review to the NDA for QTORIN 3.9% rapamycin anhydrous gel in microcystic lymphatic malformations.","PDUFA target action date set for February 28, 2027; if approved, would be the first FDA-approved therapy for microcystic LMs (>30,000 diagnosed in U.S.).","Phase 3 SELVA met all six prespecified endpoints (all p<0.001); 95% of participants aged 6+ completing evaluation improved on the mLM-IGA primary endpoint.","No drug-related serious adverse events in SELVA; systemic rapamycin concentrations below 2 ng/mL at all measured timepoints.","Palvella is preparing a standalone U.S. commercial launch in the first half of 2027; also advancing QTORIN rapamycin in venous malformations and angiokeratomas."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-435113","json":"https://secwatch.observer/filing/0001193125-26-435113.json","markdown":"https://secwatch.observer/filing/0001193125-26-435113.md","text":"https://secwatch.observer/filing/0001193125-26-435113.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1583648/000119312526435113/0001193125-26-435113-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1583648/000119312526435113/pvla-20261028.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-28T11:35:19.344817+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"}