Welcome to our dedicated page for Liquidia Corporation news (Ticker: LQDA), a resource for investors and traders seeking the latest updates and insights on Liquidia Corporation stock.
Overview
Liquidia Corporation (LQDA) is a United States-based biopharmaceutical company dedicated to transforming therapy development for pulmonary hypertension and other rare cardiopulmonary diseases. Utilizing its proprietary PRINT® Technology, the company engineers precise, uniform drug particles to optimize drug delivery and improve treatment efficacy. This innovative approach addresses critical gaps in current therapeutic options, ensuring products are manufactured under scalable, cGMP-compliant processes.
Core Technology and Business Model
At its core, Liquidia harnesses the power of PRINT® Technology to overcome common challenges in drug delivery. By producing highly controlled and uniform particles, the company enhances deposition in the lungs, which is vital for conditions such as pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Liquidia’s model includes both the advancement of its own pipeline and strategic licensing of its technology to globally recognized pharmaceutical partners.
Product Portfolio and Clinical Focus
Liquidia’s primary product candidate, YUTREPIA™ (treprostinil) inhalation powder, exemplifies its application of precision particle engineering for the treatment of PAH and PH-ILD. The company is also developing additional candidates and formulations, including a sustained-release liposomal version designed for twice-daily administration, further diversifying its clinical offerings. This broad clinical focus reinforces Liquidia’s commitment to addressing unmet patient needs.
Market Position and Competitive Landscape
Positioned in a competitive biopharmaceutical landscape, Liquidia distinguishes itself through its unique technological platform and rigorous adherence to quality standards. Its scalable PRINT® process, combined with robust clinical research and strategic partnerships, offers a scientifically sound alternative in a market with significant unmet needs. Industry-specific terms such as "drug particle engineering", "inhaled therapeutics", and "cGMP compliance" attest to the company’s technical expertise and operational rigor.
Operational Excellence and Regulatory Focus
Liquidia’s operations are streamlined across its specialized subsidiaries, ensuring efficient research, development, and commercialization processes. The company maintains a strict focus on quality by aligning its manufacturing practices with the highest regulatory standards, hence building a foundation of trust and reliability in its product offerings. This diligence in quality control and regulatory adherence solidifies its reputation within the oncology and pulmonary care communities.
Industry Collaboration and Strategic Partnerships
Liquidia actively collaborates with major pharmaceutical entities, both to license its PRINT® platform and to accelerate the commercialization of its products. These partnerships allow for a mutual exchange of expertise and resources, further enhancing its market reach and ensuring that advanced therapies are delivered efficiently. Such strategic alliances are critical for fostering innovation and establishing a competitive advantage in the complex healthcare landscape.
Commitment to Innovation and Quality
With a commitment to continuous innovation, Liquidia leverages extensive clinical studies and state-of-the-art manufacturing processes to bring safer and more effective treatment options to patients. Emphasizing precision in every phase of development, the company sets itself apart by ensuring that its therapies are optimally designed to tackle the challenges of pulmonary hypertension and related ailments.
Liquidia Corporation (NASDAQ: LQDA) appointed Dr. Roger Jeffs as CEO, effective January 3, 2022. He succeeds Damian deGoa, who will remain on the board until January 31, 2022. Dr. Jeffs, who has extensive experience in drug development, aims to optimize the upcoming launch of YUTREPIA™ (treprostinil) inhalation powder, which recently received tentative FDA approval. The company focuses on pulmonary arterial hypertension and plans to leverage its PRINT® Technology for future developments. This leadership change comes as Liquidia prepares for potential profitability with YUTREPIA's launch.
Liquidia Corporation (LQDA) announced a partial judgment in its favor regarding U.S. Patent No. 9,604,901 in ongoing litigation with United Therapeutics Corporation (UTC) under the Hatch-Waxman Act. The court's decision acknowledged Liquidia’s non-infringement of the patent, while UTC retains appellate rights. This ruling allows the ongoing regulatory stay of YUTREPIA™ (treprostinil) inhalation powder approval by the FDA to continue under U.S. Patent No. 9,593,066. The trial is scheduled for March 28-30, 2022.
Liquidia Corporation (NASDAQ: LQDA) has announced that its Chief Financial Officer, Michael Kaseta, will speak at the Jefferies 2021 Virtual London Healthcare Conference from November 16-19, 2021. The insightful fireside chat will be available on-demand from 8:00 a.m. GMT on November 18, 2021, for registered participants. Investors can access the webcast on Liquidia's website, which will remain archived for 30 days post-event. Liquidia focuses on the development of innovative therapies for pulmonary hypertension, including YUTREPIA™, an inhalation powder treatment.
Liquidia Corporation (NASDAQ: LQDA) announced the FDA granted tentative approval for YUTREPIA™ (treprostinil) inhalation powder, intended for treating pulmonary arterial hypertension (PAH). This approval, which confirms YUTREPIA's compliance with safety, quality, and efficacy standards, is a pivotal step toward market introduction. However, final approval awaits the resolution of ongoing litigation with United Therapeutics, impacting the commercial launch timeline, potentially slated for October 2022. YUTREPIA aims to provide a user-friendly alternative to existing therapies, targeting a significant market with sales exceeding $480 million.
Liquidia Corporation (LQDA) reported Q3 2021 financial results, highlighting a rise in Treprostinil Injection adoption among patients and payers, which doubled the patient count since May 2021. Revenue for Q3 was $3.2 million, compared to zero in Q3 2020, driven by a promotion agreement with Sandoz. However, revenue was impacted by a reduction in profit split percentage. The net loss decreased to $7.3 million, or $0.14 per share, from $15.0 million in Q3 2020. The FDA completed pre-approval inspections for LIQ861, with a decision expected by November 7, 2021.
Liquidia Corporation (NASDAQ: LQDA) achieved a favorable ruling from the U.S. Patent Trial and Appeal Board (PTAB) in its patent dispute with United Therapeutics Corporation. The PTAB deemed seven of the nine claims of U.S. Patent No. 9,604,901 unpatentable, leaving only narrower claims 6 and 7. This decision does not resolve ongoing litigation under the Hatch-Waxman Act regarding LIQ861, an investigational treatment for pulmonary arterial hypertension. Liquidia aims to commercialize LIQ861 following resolution of the litigation.
Liquidia Corporation (NASDAQ: LQDA) announced that CEO Damian deGoa will present at the H.C. Wainwright 23rd Annual Global Investment Conference, scheduled for September 13-15, 2021. The presentation will be virtual and available on-demand in the Investors section of Liquidia's website starting at 7:00 a.m. ET on September 13, 2021. It will remain accessible for 30 days post-conference. Liquidia focuses on the development of products for pulmonary hypertension using its PRINT® Technology.
Liquidia Corporation (NASDAQ: LQDA) announced that the FDA has completed a Pre-Approval Inspection (PAI) of its Morrisville, NC facility for the New Drug Application (NDA) of LIQ861 (treprostinil) inhalation powder. The inspection, which lasted five days and concluded on August 13, resulted in no Form 483 observations, marking a positive milestone for the company. The NDA, resubmitted on June 2, includes necessary clarifications and is under FDA review, with a PDUFA goal date set for November 7, 2021. The inspection supports Liquidia's proprietary PRINT® technology for enhanced drug delivery.
Liquidia Corporation (NASDAQ: LQDA) announced that the U.S. Patent Trial and Appeal Board (PTAB) has initiated inter partes review (IPR) of United Therapeutics' U.S. Patent No. 10,716,793. The PTAB indicated a reasonable likelihood of Liquidia succeeding in demonstrating the patent's unpatentability. This development could advance Liquidia's efforts to introduce LIQ861, an inhaled dry powder formulation of treprostinil, to treat pulmonary arterial hypertension (PAH). The FDA is reviewing the LIQ861 New Drug Application with a goal date set for November 7, 2021.
Liquidia Corporation (NASDAQ: LQDA) announced significant developments in its recent press release. It launched subcutaneous delivery of Treprostinil Injection, effectively doubling the market potential for this treatment. The company has also resubmitted its New Drug Application (NDA) for LIQ861, which received FDA acceptance for review, with a PDUFA goal date set for November 7, 2021. Financially, Liquidia has improved its balance sheet, reducing annual spending and increasing cash resources to $67.9 million as of June 30, 2021, while reporting revenue of $3.4 million in Q2 2021.
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