MORRISVILLE, N.C., June 23, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, today announced the receipt of an additional $50.0 million under its sixth amendment to its financing agreement (HCR Agreement) with Healthcare Royalty (HCRx) upon the U.S. District Court for the Middle District of North Carolina denying United Therapeutics Corporation’s request for a preliminary injunction and t ...

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]

Group 1 - The U.S. FDA approved Liquidia Corporation's LQDA Yutrepia (treprostinil) inhalation powder for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability [1] - In August 2024, the FDA issued tentative approval of Yutrepia for the PAH and PH-ILD indications [1] - Following the announcement, Liquidia shares fell 5.2% to trade at $14.80 [1] Group 2 - Wells Fargo analyst Tiago Fauth maintained an Overweight rating on Liquidia and raised the price target from $20 to $23 [6] - HC Wainwright & Co. analyst Andrew Fein maintained a Buy rating and raised the price target from $29 to $35 [6] - Needham analyst Serge Belanger reiterated a Buy rating and maintained a $25 price target [6]

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 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]

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].

Company Overview - Liquidia Technologies, Inc. (LQDA) shares increased by 13.2% to close at $15.83, with notable trading volume compared to typical sessions, following a 1.1% loss over the past four weeks [1][2] Recent Developments - The U.S. District Court for the District of Columbia dismissed a cross-claim by United Therapeutics challenging Liquidia's amendment to its new drug application for Yutrepia, which now includes treatment for pulmonary hypertension associated with interstitial lung disease (PH-ILD) [2] Financial Expectations - Liquidia is expected to report a quarterly loss of $0.42 per share, reflecting a year-over-year increase of 22.2%, with revenues projected at $3.31 million, up 11.4% from the previous year [3] - The consensus EPS estimate for Liquidia has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Liquidia Technologies operates within the Zacks Medical - Biomedical and Genetics industry, where CRISPR Therapeutics AG (CRSP) also competes, having closed 1.4% higher at $38.25 and showing a 15.5% return over the past month [4]

Core Viewpoint - Liquidia Corporation has received a favorable ruling from the U.S. District Court, which dismissed United Therapeutics' cross-claim against its New Drug Application (NDA) for YUTREPIA, allowing the company to proceed with its plans for the drug's approval [1][2]. Group 1: Legal Developments - The U.S. District Court dismissed United Therapeutics' cross-claim regarding Liquidia's amendment to its NDA for YUTREPIA, determining that the claim was unripe and lacked standing [1][2]. - United Therapeutics retains the right to appeal the court's decision [2]. Group 2: Product Development and Approval Timeline - The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for the YUTREPIA NDA on May 24, 2025, following the expiration of regulatory exclusivity on May 23, 2025 [3][6]. - Liquidia aims for YUTREPIA to become the preferred treatment for patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [2][4]. Group 3: Company Overview - Liquidia Corporation focuses on developing innovative therapies for rare cardiopulmonary diseases, with a particular emphasis on pulmonary hypertension [4]. - The company is also working on L606, a sustained-release formulation of treprostinil, and markets a generic version of Treprostinil Injection for PAH treatment [4].

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]

Liquidia Corporation (NASDAQ:LQDA) Q4 2024 Earnings Conference Call March 19, 2025 8:30 AM ET Company Participants Jason Adair - Chief Business Officer Roger Jeffs - CEO Michael Kaseta - COO and CFO Rajeev Saggar - Chief Medical Officer Scott Moomaw - Chief Commercial Officer Rusty Schundler - General Counsel Conference Call Participants Julian Harrison - BTIG Serge Belanger - Needham Ryan Deschner - Raymond James Greg Harrison - Scotiabank Cory Jubinville - LifeSci Capital Operator Good morning. And welcom ...