FDA Grants Fast Track to Liquidia's Yutrepia for Scleroderma-Linked Raynaud's

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Liquidia Corporation announced that the FDA has granted Fast Track designation to Yutrepia (treprostinil) inhalation powder for the treatment of Raynaud's phenomenon associated with systemic sclerosis, or SSc-RP. Yutrepia, an inhaled dry-powder formulation of treprostinil developed with Liquidia's proprietary PRINT technology, was approved by the FDA in May 2025 for PAH and pulmonary hypertension associated with interstitial lung disease. Liquidia plans to initiate RE-WARM, a phase IIa, randomized, open-label, dose-finding study of Yutrepia in approximately 75 adults with SSc experiencing symptomatic Raynaud's phenomenon attacks, at up to 30 U.S. sites, with the study expected to begin in October 2026 and primary completion targeted for February 2027. Since its commercial launch in June 2025, Yutrepia has generated approximately $300.3 million in sales in the first half of 2026, with about 5,900 unique prescriptions and more than 5,000 patients initiated. The company also plans to evaluate the therapy in pulmonary hypertension associated with chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, while competing in the PAH market against United Therapeutics' Tyvaso and Tyvaso DPI and Insmed's clinical-stage TPIP and INS1148 programs.

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FDA granted Fast Track designation to Liquidia's Yutrepia for Raynaud's phenomenon associated with systemic sclerosis.

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