Liquidia Corporation (Nasdaq: LQDA) announced that the U.S. Food and Drug Administration has granted Fast Track designation to its drug Yutrepia (treprostinil) inhalation powder for the treatment of Raynaud's phenomenon associated with systemic sclerosis, known as SSc-RP.

Systemic sclerosis is a rare, chronic autoimmune disease, and Raynaud's phenomenon affects up to 90% of SSc patients, causing recurrent vasospastic episodes that produce pain, numbness, and color changes in the fingers and toes. The condition can progress to digital ischemic ulcers in an estimated 40% to 60% of patients and, in recurring cases, digital amputation. No therapy is currently approved in the U.S. specifically to treat SSc-RP. Liquidia estimates the addressable U.S. patient population with moderate to severe symptoms at approximately 30,000.

The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions with unmet medical need. The designation gives Liquidia more frequent interactions with the FDA, potential for rolling review of a New Drug Application, and possible eligibility for Priority Review and Accelerated Approval if relevant criteria are met.

Liquidia plans to initiate RE-WARM, 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 30 sites in the United States. The study is expected to begin in October 2026, with primary completion targeted for February 2027.

Yutrepia is currently approved for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. The drug has not been approved for SSc-RP, and the company noted that Fast Track designation does not guarantee eventual FDA approval for this use.

Chief Medical Officer Dr. Rajeev Saggar said: "Fast Track designation reflects the seriousness of this condition and the need for new options."