Core Insights - Liquidia Corporation has announced the first commercial shipment of YUTREPIA™ (treprostinil) inhalation powder, following FDA approval on May 23, 2025, for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [1][6] - The company has moved quickly to promote YUTREPIA, with its sales force actively engaging in the market just over a week after FDA approval [2] - A recent court ruling denied United Therapeutics' request for a preliminary injunction against Liquidia, allowing for the full commercial launch of YUTREPIA [2] Company Overview - Liquidia Corporation is a biopharmaceutical company focused on developing innovative therapies for rare cardiopulmonary diseases, particularly in pulmonary hypertension [9] - The company utilizes its proprietary PRINT technology to create drug formulations, including YUTREPIA, which is designed for enhanced lung deposition [5][9] - Liquidia is also developing L606, a sustained-release formulation of treprostinil, and markets generic Treprostinil Injection for PAH treatment [9] Product Information - YUTREPIA is an inhaled dry-powder formulation of treprostinil, delivered through a user-friendly device, aimed at providing a new therapeutic option for patients with PAH and PH-ILD [5][6] - The product was previously known as LIQ861 during investigational studies and has undergone clinical trials to establish its safety and efficacy [5] Disease Context - PAH is a rare, chronic disease affecting approximately 45,000 patients in the U.S., with no current cure, making symptom management and quality of life improvement critical [3] - PH-ILD encompasses a range of pulmonary diseases affecting over 60,000 patients in the U.S., with associated poor survival rates [4]

MORRISVILLE, N.C., May 28, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) announced today that the company's Chief Executive Officer Dr. Roger Jeffs, Chief Financial Officer and Chief Operating Officer Michael Kaseta, and Chief Business Officer Jason Adair will be providing an update on the company's business during a fireside chat at the 2025 Jefferies Global Healthcare Conference on Wednesday June 4, 2025, beginning at 11:05 a.m. ET, in New York City. Access to a webcast will be available to ...

Core Viewpoint - Liquidia Corporation is focused on the potential commercialization of YUTREPIA, an inhalation powder for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), with an FDA decision expected by May 24, 2025 [2][3][8]. Corporate Updates - The FDA accepted Liquidia's New Drug Application (NDA) resubmission for YUTREPIA, setting a PDUFA goal date of May 24, 2025, coinciding with the expiration of regulatory exclusivity for Tyvaso DPI [3][8]. - A U.S. District Court dismissed a cross-claim from United Therapeutics challenging the NDA amendment for YUTREPIA, allowing Liquidia to proceed without legal hindrance [4][8]. - Liquidia completed enrollment of Cohort A in the ASCENT study, with over 50 patients, showing promising results in dosing and tolerability [5][8]. Financial Position - Liquidia entered into a sixth amendment with HealthCare Royalty, allowing for up to an additional $100 million in financing to support the development of YUTREPIA and other clinical trials [6][8]. - As of March 31, 2025, cash and cash equivalents were $169.8 million, a decrease from $176.5 million at the end of 2024 [7][8]. - Revenue for Q1 2025 was $3.1 million, a slight increase from $3.0 million in Q1 2024, primarily from a promotion agreement with Sandoz [9][8]. Expenses and Losses - Research and development expenses decreased by 31% to $7.0 million in Q1 2025, down from $10.1 million in Q1 2024, due to a shift in focus towards commercialization [11][8]. - General and administrative expenses rose by 48% to $30.1 million in Q1 2025, attributed to increased personnel costs and legal fees [12][8]. - The net loss for Q1 2025 was $38.4 million, or $0.45 per share, compared to a net loss of $30.1 million, or $0.40 per share, in Q1 2024 [14][8].

Core Points - Liquidia Corporation will report its first quarter 2025 financial results on May 8, 2025, and will host a webcast at 8:30 a.m. Eastern Time to discuss these results and provide a corporate update [1][2] Company Overview - Liquidia Corporation is a biopharmaceutical company focused on developing innovative therapies for patients with rare cardiopulmonary diseases [3] - The company's primary focus includes the development and commercialization of products for pulmonary hypertension, utilizing its proprietary PRINT Technology [3] - Liquidia's lead candidate is YUTREPIA™ (treprostinil) inhalation powder, aimed at treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [3] - The company is also developing L606, a sustained-release formulation of treprostinil, and markets generic Treprostinil Injection for PAH treatment [3]