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

Liquidia Corp

FDA granted Fast Track designation to YUTREPIA (treprostinil) inhalation powder for systemic sclerosis-associated Raynaud's phenomenon (SSc-RP).
No therapy is currently FDA-approved for SSc-RP; condition affects up to 90% of systemic sclerosis patients.
Liquidia plans to initiate RE-WARM, a Phase 2a dose-finding study of YUTREPIA in SSc-RP, in Q4 2026.
Company estimates U.S. addressable population of ~30,000 moderate-to-severe SSc-RP patients.
Fast Track enables more frequent FDA interactions and potential rolling review and Priority Review eligibility.

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