YUTREPIA (treprostinil) inhalation powder - (RE-WARM)

September 3, 2026: Liquidia Corporation (NASDAQ: LQDA) said the FDA granted Fast Track designation to YUTREPIA (treprostinil) inhalation powder for Raynaud’s phenomenon associated with systemic sclerosis (SSc-RP). The company said no FDA-approved therapy currently exists for SSc-RP in the U.S.

Liquidia plans to start RE-WARM (NCT07748000), a Phase 2a randomized, open-label, dose-finding study, in October 2026. The trial will enroll about 75 adults with systemic sclerosis and symptomatic Raynaud’s attacks at up to 30 U.S. sites. The study is designed to assess safety and pharmacodynamics and to explore whether YUTREPIA reduces the number, severity, and impact of attacks. Primary completion is targeted for February 2027.

The release notes SSc-RP affects up to 90% of SSc patients, with digital ischemic ulcers occurring in an estimated 40% to 60% of patients. Liquidia estimates about 30,000 U.S. patients with moderate to severe symptoms are addressable. YUTREPIA is approved for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, but not for SSc-RP; the company stated Fast Track does not guarantee FDA approval for this use.