Biopharma · FDA Approvals · Stock
Liquidia Corp is a United States-based biopharmaceutical company focused on the development, manufacturing, and commercialization of products that address unmet patient needs, with the current focus directed towards the treatment of pulmonary hypertension (PH) and pulmonary hypertension associated with interstitial lun…
Assets on file: treprostinil
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Liquidia Settles All Litigation with United Therapeutics, Keeps YUTREPIA on Market for PAH
Liquidia reached a global settlement with United Therapeutics resolving all six pending lawsuits, including patent infringement, trade secret, breach of contract, and antitrust claims. As part of the deal, Liquidia will pay a net $380.7 million in installments during 2026-2027, will not appeal the recent court ruling on the '327 patent, has submitted a label supplement to remove the PH-ILD indication from YUTREPIA, and will cease promotion for PH-ILD while maintaining uninterrupted commercialization for PAH. The settlement provides regulatory and commercial certainty for YUTREPIA in PAH without altering its approved status or ongoing development programs for other indications.
Liquidia (LQDA) District Court rules against YUTREPIA's PH-ILD indication
The District Court ruled that two claims of the '327 patent are valid and infringed, specifically those covering the treatment of PH-ILD patients with inhaled treprostinil. Liquidia intends to supplement its NDA to remove PH-ILD from YUTREPIA's label and is considering all appellate options.
Liquidia: FDA grants Fast Track to YUTREPIA for SSc-RP
FDA granted Fast Track designation to YUTREPIA for SSc-RP, recognizing the unmet need. Liquidia will start the Phase 2a RE-WARM study in Q4 2026 to evaluate safety and pharmacodynamics in ~75 adults.
Liquidia: YUTREPIA (treprostinil) full FDA approval drives Q3 profitability
The document confirms full FDA approval of YUTREPIA was received on May 23, 2025, enabling U.S. commercial launch in June 2025. This marks the first full quarter of product sales, generating $51.7 million in net revenue and achieving operating profitability. The approval covers both PAH and PH-ILD indications to improve exercise ability.
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