---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-104929"
form_type: "8-K"
ticker: "LQDA"
cik: "0001819576"
company_name: "Liquidia Corp"
filed_at: "2026-09-03T12:00:31+00:00"
generated_at: "2026-09-03T12:05:15.461520+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA grants Fast Track to Liquidia's YUTREPIA for SSc-Raynaud's phenomenon

## Summary
- FDA granted Fast Track designation to YUTREPIA (treprostinil) inhalation powder for systemic sclerosis-associated Raynaud's phenomenon (SSc-RP).
- No therapy is currently FDA-approved for SSc-RP; condition affects up to 90% of systemic sclerosis patients.
- Liquidia plans to initiate RE-WARM, a Phase 2a dose-finding study of YUTREPIA in SSc-RP, in Q4 2026.
- Company estimates U.S. addressable population of ~30,000 moderate-to-severe SSc-RP patients.
- Fast Track enables more frequent FDA interactions and potential rolling review and Priority Review eligibility.

## SEC filing metadata
- accession: 0001104659-26-104929
- form_type: 8-K
- ticker: LQDA
- cik: 0001819576
- company_name: Liquidia Corp
- filed_at: 2026-09-03T12:00:31+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1819576/000110465926104929/0001104659-26-104929-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1819576/000110465926104929/tm2624724d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-104929
- JSON: https://secwatch.observer/filing/0001104659-26-104929.json
- Plain text: https://secwatch.observer/filing/0001104659-26-104929.txt

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