---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-090676"
form_type: "8-K"
ticker: "LQDA"
cik: "0001819576"
company_name: "Liquidia Corp"
filed_at: "2024-08-19T23:59:59+00:00"
generated_at: "2026-05-31T08:42:32.926188+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA grants tentative approval for Liquidia's YUTREPIA but final approval delayed to May 2025 due to exclusivity

## Summary
- FDA granted tentative approval of YUTREPIA (treprostinil) inhalation powder for PAH and PH-ILD on Aug 19, 2024.
- Final approval delayed until after expiration of Tyvaso DPI's three-year new dosage form exclusivity on May 23, 2025.
- Liquidia plans to challenge FDA's broad grant of regulatory exclusivity to United Therapeutics for Tyvaso DPI.
- Tentative approval confirms YUTREPIA meets FDA standards for quality, safety, and efficacy but cannot be marketed yet.

## SEC filing metadata
- accession: 0001104659-24-090676
- form_type: 8-K
- ticker: LQDA
- cik: 0001819576
- company_name: Liquidia Corp
- filed_at: 2024-08-19T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- 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/1819576/000110465924090676/0001104659-24-090676-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1819576/000110465924090676/tm2421912d2_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-090676
- JSON: https://secwatch.observer/filing/0001104659-24-090676.json
- Plain text: https://secwatch.observer/filing/0001104659-24-090676.txt

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