$LQDA (LIQUIDIA) — 8-K: FDA grants Fast Track to YUTREPIA for systemic sclerosis Raynaud’s

The FDA granted Fast Track designation to YUTREPIA (treprostinil) inhalation powder for Raynaud’s phenomenon associated with systemic sclerosis (SSc-RP). No therapy is currently approved in the U.S. for SSc-RP, which affects up to 90% of systemic sclerosis patients. Liquidia estimates the addressable U.S. population with moderate to severe symptoms at approximately 30,000 patients. Liquidia plans to initiate the Phase 2a RE-WARM dose-finding study in approximately 75 adults in October 2026.

The FDA granted Fast Track designation to YUTREPIA (treprostinil) inhalation powder for Raynaud’s phenomenon associated with systemic sclerosis (SSc-RP). No therapy is currently approved in the U.S. for SSc-RP, which affects up to 90% of systemic sclerosis patients. Liquidia estimates the addressable U.S. population with moderate to severe symptoms at approximately 30,000 patients. Liquidia plans to initiate the Phase 2a RE-WARM dose-finding study in approximately 75 adults in October 2026.