---
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"
generated_at: "2026-10-28T11:35:19.344817+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Palvella's QTORIN rapamycin NDA with Priority Review; PDUFA date Feb 28, 2027

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-435113
- JSON: https://secwatch.observer/filing/0001193125-26-435113.json
- Plain text: https://secwatch.observer/filing/0001193125-26-435113.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.