FDA grants fast track status to Liquidia's Yutrepia for rare condition

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FDA Grants Fast Track Designation to YUTREPIA® for the Treatment of Raynaud's Phenomenon Associated with Systemic Sclerosis

September 3, 2026 7:30 AM EDT

Fast Track designation underscores the significant unmet need for patients with systemic sclerosis-associated Raynaud's phenomenon (SSc-RP), a debilitating manifestation affecting up to 90% of SSc patientsNo therapy is currently approved in the U.S. to treat SSc-RP and management options are limited and often inadequate for patients with more severe diseaseLiquidia plans to initiate RE-WARM, a Phase 2a dose-finding study of YUTREPIA in SSc-RP, in the fourth quarter of 2026

MORRISVILLE, N.C., Sept. 03, 2026 (GLOBE NEWSWIRE) -- Liquidia Corporation (Nasdaq:... More