litigation
confidence high
sentiment positive
materiality 0.80
Liquidia wins dismissal of UTHR cross-claim over YUTREPIA PH-ILD label; FDA approval path cleared
Liquidia Corp
- District Court dismissed UTHR's cross-claim without prejudice for lack of standing and ripeness.
- FDA can grant final YUTREPIA approval after regulatory exclusivity expires on May 23, 2025.
- PDUFA goal date for YUTREPIA NDA remains May 24, 2025.
- UTHR retains the right to appeal the court's ruling.
- CEO cites court decision as validating FDA's acceptance of PH-ILD indication in NDA.