---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-006477"
form_type: "8-K"
ticker: "LQDA"
cik: "0001819576"
company_name: "Liquidia Corp"
filed_at: "2024-01-25T23:59:59+00:00"
generated_at: "2026-06-06T18:28:06.338999+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA delays YUTREPIA PDUFA date; PH-ILD amendment process ongoing

## Summary
- FDA unable to issue action letter by Jan. 24, 2024 PDUFA date; no new goal date set.
- No additional clinical data requested; FDA confirming process to add PH-ILD indication.
- Federal Circuit upheld PTAB invalidity of '793 patent; '327 patent not subject to 30-month stay.
- Company expects final approval after Tyvaso regulatory exclusivity expires March 31, 2024.
- YUTREPIA already has tentative approval for PAH; quality, safety, efficacy standards met.

## SEC filing metadata
- accession: 0001104659-24-006477
- form_type: 8-K
- ticker: LQDA
- cik: 0001819576
- company_name: Liquidia Corp
- filed_at: 2024-01-25T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1819576/000110465924006477/0001104659-24-006477-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1819576/000110465924006477/tm244104d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-006477
- JSON: https://secwatch.observer/filing/0001104659-24-006477.json
- Plain text: https://secwatch.observer/filing/0001104659-24-006477.txt

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