FDA grants Fast Track designation to Liquidia's YUTREPIA for SSc-related Raynaud's phenomenon

Liquidia Corporation said on September 3, 2026 that the FDA has granted Fast Track designation to YUTREPIA (treprostinil) inhalation powder for the treatment of Raynaud's phenomenon associated with systemic sclerosis (SSc-RP).¹ The company noted that the potential use of YUTREPIA in SSc-RP is currently under clinical development, and its safety and efficacy for this indication have not been evaluated by any regulatory authority.¹

According to the release, SSc-RP affects up to 90% of SSc patients, with attacks that are more frequent, prolonged and severe than primary Raynaud's, often progressing to digital ischemic ulcers in an estimated 40% to 60% of patients and, in recurrent cases, digital amputation.¹ Liquidia estimates that the addressable population of SSc-RP patients with moderate to severe symptoms is approximately 30,000 patients in the United States.¹

The company plans to launch RE-WARM, described as a Phase 2a, randomized, open-label, dose-finding study of YUTREPIA in approximately 75 adults with SSc experiencing symptomatic Raynaud's phenomenon attacks, at up to approximately 30 sites in the United States.¹ The release states the study is designed to characterize the safety and pharmacodynamics of YUTREPIA in this population, and also explores whether treatment reduces the number, severity and impact of RP attacks.¹ Liquidia said the study is expected to begin in October 2026, with primary completion targeted for February 2027.¹

YUTREPIA is currently approved for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).¹ Liquidia cautioned that YUTREPIA is not approved for the treatment of Raynaud's phenomenon associated with systemic sclerosis, and there is no guarantee that the FDA will ultimately approve YUTREPIA for this use, even with Fast Track designation.¹