regulatory
confidence high
sentiment positive
materiality 0.75
Liquidia's YUTREPIA NDA resubmission accepted; PDUFA date May 24, 2025
Liquidia Corp
- FDA accepted Liquidia's NDA resubmission for YUTREPIA (treprostinil) inhalation powder.
- Resubmission is a complete, Class 1 response to the August 16, 2024 action letter.
- FDA granted tentative approval for PAH and PH-ILD; final approval decision by May 24, 2025.
- Company preparing for launch of YUTREPIA pending final FDA approval.