YUTREPIA™ (treprostinil) Inhalation Powder
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Liquidia Corporation Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-11-03 11:30
Core Insights - Liquidia Corporation reported its financial results for Q3 2025, highlighting the successful launch of YUTREPIA and its potential in treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [1][2] Financial Performance - The company recorded a net loss of $3.5 million in Q3 2025, a significant improvement from a net loss of $31.0 million in the same quarter of the previous year [3][11] - Operating income for the quarter was $1.7 million, with a positive non-GAAP adjusted EBITDA of $10.1 million [3][27] - Cash and cash equivalents stood at $157.5 million as of September 30, 2025, down from $176.5 million at the end of 2024 [3] Revenue Breakdown - Net product sales for YUTREPIA reached $51.7 million for the three months ended September 30, 2025, marking the first full quarter of sales following its FDA approval [4][9] - Service revenue was $2.7 million, a decrease from $4.4 million in Q3 2024, primarily due to lower sales volumes [5] Cost Analysis - Cost of product sales was $2.3 million for Q3 2025, with no costs recorded in 2024 [6] - Research and development expenses decreased to $9.3 million, down 21% from $11.9 million in the prior year, mainly due to a shift in focus towards commercialization [8] - Selling, general, and administrative expenses increased to $40.1 million, a 98% rise from $20.2 million in Q3 2024, driven by higher personnel and commercial expenses [9][10] Prescription and Market Engagement - As of October 30, 2025, over 2,000 unique prescriptions for YUTREPIA have been received, with shipments to more than 1,500 patients supported by over 600 prescribers nationwide [2][9] Product Information - YUTREPIA is an inhaled dry-powder formulation of treprostinil, designed for the treatment of PAH and PH-ILD, utilizing Liquidia's proprietary PRINT technology [13][18] - The company is also developing L606, an investigational sustained-release formulation of treprostinil, which is currently in clinical evaluation [14][18]
Liquidia to Present Clinical Data from ASCENT Trial at the CHEST 2025 Annual Meeting
Globenewswire· 2025-09-29 12:30
Core Insights - Liquidia Corporation will present two oral presentations at the CHEST 2025 annual meeting focusing on new data from the ASCENT trial related to LIQ861 DPI treprostinil in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) [1][2] Group 1: Presentation Details - The first presentation titled "Changes in Cardiac Effort in Pulmonary Hypertension-Interstitial Lung Disease: Insights from ASCENT" will be held on October 21, 2025, at 10:20 a.m. CT, presented by Dr. Dan Lachant [3] - The second presentation titled "Safety and Exploratory Efficacy Data of LIQ861 DPI Treprostinil in PH-ILD: ASCENT to Week 16" will also take place on October 21, 2025, at 1:52 p.m. CT, presented by Dr. Nicholas Kolaitis [3] Group 2: ASCENT Study Overview - The ASCENT study is an open-label, prospective, multicenter trial evaluating the safety and tolerability of LIQ861 in subjects with WHO Group 1 and 3 pulmonary hypertension, specifically focusing on a cohort of 54 subjects with PH-ILD [4] - The primary objective of the study is to assess the safety and tolerability of LIQ861, while exploratory objectives include evaluating its effects on exercise capacity, functional class, biomarkers, and imaging assessments [4] Group 3: Product Information - YUTREPIA™ is an inhaled dry-powder formulation of treprostinil designed for the treatment of pulmonary arterial hypertension (PAH) and PH-ILD, aimed at improving exercise ability [5] - The product utilizes Liquidia's PRINT technology, which allows for the creation of drug particles that are precise and uniform, enhancing deposition in the lungs [5] Group 4: Company Overview - Liquidia Corporation focuses on developing innovative therapies for rare cardiopulmonary diseases, with a current emphasis on pulmonary hypertension and applications of its proprietary PRINT technology [6] - The company has developed YUTREPIA™ as its first approved product and is also working on L606, an investigational sustained-release formulation of treprostinil [6]
Liquidia Announces Poster Presentations at the Pulmonary Hypertension Professional Association (PHPN) Symposium
Globenewswire· 2025-09-11 12:30
Core Insights - Liquidia Corporation will present four posters at the Pulmonary Hypertension Professional Association (PHPN) Symposium from September 18 to 20, 2025, in Seattle, focusing on innovative therapies for rare cardiopulmonary diseases [1][2]. Group 1: Presentation Details - The live thematic poster session will showcase new safety and exploratory efficacy data for LIQ861 (YUTREPIA™) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) from the ASCENT study [2]. - Three previously published posters will also be presented, covering YUTREPIA's effects on cardiac effort, quality of life, and patient device usage [2][4]. Group 2: Poster Abstracts - The first poster will discuss initial safety and exploratory efficacy data on LIQ861 in PH-ILD patients [4]. - The second poster will provide insights into changes in cardiac effort in PH-ILD patients from the ASCENT trial [4]. - The third poster will focus on quality of life in pulmonary arterial hypertension (PAH) patients receiving LIQ861 in the INSPIRE study [4]. - The fourth poster will address the robustness of LIQ861 in patient misuse scenarios [5]. Group 3: Product Information - YUTREPIA is an inhaled dry-powder formulation of treprostinil, designed for the treatment of PAH and PH-ILD, aimed at improving exercise ability [5]. - The product utilizes Liquidia's PRINT technology, which allows for precise and uniform drug particle development for enhanced lung deposition [5][6]. - Liquidia is also developing L606, a sustained-release formulation of treprostinil, and markets generic Treprostinil Injection for PAH treatment [6].
U.S. FDA Approves Liquidia's YUTREPIA™ (treprostinil) Inhalation Powder for Patients with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
GlobeNewswire News Room· 2025-05-23 18:28
Core Viewpoint - Liquidia Corporation has received FDA approval for YUTREPIA™ (treprostinil) inhalation powder, a new treatment option for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) aimed at improving exercise ability [1][4] Company Overview - Liquidia Corporation is a biopharmaceutical company focused on developing innovative therapies for rare cardiopulmonary diseases, utilizing its proprietary PRINT™ technology to create drug formulations [10] Product Details - YUTREPIA is the first and only prostacyclin dry-powder formulation designed for deep-lung delivery using a low-effort inhalation device, enhancing patient experience [1][7] - The approval of YUTREPIA is based on the Phase 3 INSPIRE trial, which demonstrated its safety and tolerability for patients naïve to treprostinil and those transitioning from nebulized forms [2][7] Market Impact - The introduction of YUTREPIA provides a new treatment option for over 105,000 patients in the U.S. suffering from PAH and PH-ILD, addressing a significant unmet medical need [2][5] - The product is expected to improve the quality of life for patients, as highlighted by industry leaders and patient advocacy groups [2][6] Legal Considerations - United Therapeutics Corporation has filed a complaint against Liquidia alleging patent infringement related to YUTREPIA, which may impact its commercialization [2][10] Upcoming Events - Liquidia plans to host a live webcast on May 27, 2025, to provide updates on the commercial launch preparations for YUTREPIA [3][4]