other material
confidence high
sentiment positive
materiality 0.85
Judge lifts YUTREPIA injunction; Tyvaso PH-ILD exclusivity expires March 31
Liquidia Corp
- March 28: Judge Andrews set aside August 2022 injunction; FDA can now approve YUTREPIA NDA.
- March 29: Judge Bates denied United Therapeutics' motion for TRO/preliminary injunction against FDA approval.
- March 31: Regulatory exclusivity for Tyvaso in PH-ILD expired; FDA can act on YUTREPIA amended NDA.
- United Therapeutics filed appeal and new lawsuits, but none currently block YUTREPIA launch.
- Liquidia commercial team ready to launch for PAH and PH-ILD upon FDA final approval.