Liquidia Corporation announced that its product, YUTREPIA® (treprostinil) inhalation powder, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA). This designation is for the potential treatment of Raynaud’s phenomenon associated with systemic sclerosis (SSc-RP), a condition with no currently approved therapies in the U.S.

Key Details

  • Regulatory Milestone: On September 3, 2026, the FDA granted Fast Track Designation to YUTREPIA for treating SSc-RP, a program designed to expedite the development and review of drugs for serious conditions with unmet medical needs.
  • Clinical Trial Plans: The company plans to initiate a Phase 2a dose-finding study, named RE-WARM, in Q4 2026. The study is expected to begin in October 2026 with a targeted primary completion date of February 2027.
  • Market Opportunity: Liquidia estimates the addressable U.S. patient population for moderate to severe SSc-RP is approximately 30,000 patients.