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Can a Potential Label Expansion of Yutrepia Boost LQDA's Portfolio?
Liquidia Corporation LQDA recently 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 (SSc-RP).
Lead drug Yutrepia is an inhaled dry-powder formulation of treprostinil developed using Liquidia’s proprietary PRINT technology. The technology delivers the drug deeper into the lungs through an easy-to-use inhaler while enabling higher doses than other inhaled treprostinil therapies.
The FDA approved Yutrepia in May 2025 for the treatment of PAH and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
Liquidia is seeking to broaden Yutrepia’s growth opportunity. The company plans to evaluate the therapy in pulmonary hypertension associated with chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis (PPF) and SSc-RP. Successful expansion into these additional indications could provide Yutrepia with new avenues for long-term growth.
The FDA’s Fast Track designation is intended to facilitate the development and expedite the review of drugs targeting serious conditions with unmet medical needs. For LiquidiaLQDA--, the designation enables more frequent interactions with the FDA during development, allows for the potential rolling review of a new drug application, and, if applicable criteria are met, may support eligibility for priority review and/or accelerated approval.
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. The study is expected to be conducted at up to 30 U.S. sites and will assess Yutrepia’s safety and pharmacodynamics, while also evaluating its potential to reduce the frequency, severity and impact of RP attacks. RE-WARM is expected to begin in October 2026, with primary completion targeted for February 2027.
Systemic sclerosis (SSc) is a rare, chronic autoimmune disease characterized by widespread vascular damage and fibrosis of the skin and internal organs, with the highest mortality among systemic rheumatic diseases. Raynaud’s phenomenon, affecting up to 90% of SSc patients, causes recurrent episodes of pain, numbness and color changes in the fingers and toes and can lead to digital ulcers and, in severe cases, amputation.
Since its commercial launch in June 2025, Yutrepia has quickly emerged as Liquidia’s key growth driver, generating approximately $300.3 million in sales in the first half of 2026. Adoption has also been strong, with about 5,900 unique prescriptions since launch and more than 5,000 patients initiated on Yutrepia.
However, sustaining this growth could prove challenging. A potential label expansion of the drug in additional indications could boost its sales.
LQDA Faces Competition in PAH Market
Yutrepia competes in the PAH market against several approved inhaled prostacyclin therapies, while additional pipeline candidates could intensify competition in the coming years.
Liquidia’s primary competitor is United Therapeutics’ UTHR Tyvaso (treprostinil), an established inhaled therapy approved for PAH in 2009 and PH-ILD in 2021. UTHR also markets Tyvaso DPI, a dry-powder formulation approved for both indications in 2022, which has seen strong demand.
UTHR is further strengthening its PAH franchise with potential catalysts including ralinepag tablets for PAH and nebulized Tyvaso for IPF. Planned filings for ralinepag DPI and treprostinil SMI could provide additional growth opportunities.
Insmed INSM is also advancing several clinical-stage programs in respiratory diseases, including TPIP and INS1148.
TPIP is an inhaled dry powder formulation of the treprostinil prodrug treprostinil palmitil, which may offer a differentiated product profile for PH-ILD, PAH, PPF and IPF. The company has made encouraging progress with the program. INSM is currently enrolling patients in the PALM-ILD trial, a phase III study of TPIP in patients with PH-ILD. It is also actively enrolling patients in the PALM-PAH trial, a phase III study of TPIP in those with PAH.
Last month, the company reported positive 12-month data from the ongoing open-label extension study of TPIP in patients with PAH.
The company also plans to initiate a phase III study of TPIP in patients with PPF in the second half of 2026, followed by a phase III study in IPF in the first half of 2027.
Insmed is advancing INS1148 in a phase II program initially focused on PPF and IPF. The company is also exploring additional diseases where inhibiting the inflammatory functions of Stem Cell Factor 248 (SCF248) could provide therapeutic benefits.
LQDA’s Share Price Performance, Valuation, Estimates and Zacks Rank
Shares of LQDALQDA-- have surged 100.4% year to date compared with the industry’s growth of 7.4%.
Image Source: Zacks Investment Research
Going by the price/sales ratio, LQDA shares currently trade at 6.22X forward sales, higher than the industry’s average of 1.89X but lower than its mean of 14.68X.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for 2026 earnings per share (EPS) has moved south to $2.57 from $3.02, and that for 2027 EPS has declined to $4.38 from $4.92 in the past 60 days.
Image Source: Zacks Investment Research
LQDA currently has a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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