---
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"
generated_at: "2026-05-17T05:46:20.810441+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Palvella expands QTORIN rapamycin program into angiokeratomas, plans Phase 2 in H2 2026

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 7.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-092681
- JSON: https://secwatch.observer/filing/0001104659-25-092681.json
- Plain text: https://secwatch.observer/filing/0001104659-25-092681.txt

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