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 of Liquidia Corporation
Liquidia Corporation (NASDAQ: LQDA) is a cutting-edge biopharmaceutical company headquartered in Morrisville, North Carolina, specializing in the development and commercialization of innovative therapies for rare cardiopulmonary diseases. With a strong focus on addressing unmet medical needs, the company leverages its proprietary PRINT® (Particle Replication in Non-Wetting Templates) technology to precisely engineer drug particles, enabling enhanced drug delivery, efficacy, and safety. Liquidia operates through its two wholly owned subsidiaries, Liquidia Technologies, Inc. and Liquidia PAH, LLC.
Core Business Areas
Liquidia’s primary focus lies in the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), both of which are chronic and life-threatening conditions with limited treatment options. The company’s flagship product, YUTREPIA™ (treprostinil) inhalation powder, is an investigational, inhaled dry-powder formulation designed to offer a more convenient and effective alternative to existing therapies. YUTREPIA, developed using PRINT® technology, has received tentative FDA approval for the treatment of PAH and PH-ILD, pending final regulatory clearance.
In addition to YUTREPIA, Liquidia is advancing L606, an investigational liposomal formulation of treprostinil for nebulization, aimed at providing sustained drug release and reducing dosing frequency. The company also markets a generic version of Treprostinil Injection, a fully substitutable alternative to branded therapies, in partnership with Sandoz, Inc.
Proprietary Technology
Liquidia’s PRINT® technology is a transformative platform that enables the precise production of uniform drug particles with controlled size, shape, and composition. This scalability and versatility allow the technology to be applied across various therapeutic areas and routes of administration. By enhancing drug deposition in targeted areas, such as the lungs, PRINT® technology improves treatment efficacy while minimizing side effects.
Market Position and Competitive Landscape
The pulmonary hypertension market is characterized by significant unmet needs, offering Liquidia a unique opportunity to establish itself as a key player. However, the company operates in a highly competitive environment alongside established players like United Therapeutics. Liquidia differentiates itself through its innovative technology and patient-centric approach, which aims to simplify treatment regimens and improve quality of life for patients.
Regulatory and Legal Context
Liquidia has faced and continues to navigate complex regulatory and legal challenges. The company has been involved in multiple patent litigations with United Therapeutics, particularly concerning the commercialization of YUTREPIA. Despite these challenges, Liquidia has successfully defended its intellectual property and regulatory submissions, achieving critical milestones such as the U.S. Supreme Court’s rejection of United Therapeutics’ patent claims. The company remains committed to bringing its innovative therapies to market as quickly as possible.
Commitment to Innovation and Patient Care
Liquidia’s mission is to transform the lives of patients with rare cardiopulmonary diseases by delivering therapies that address critical gaps in care. Through its robust product pipeline, proprietary technology, and dedication to overcoming regulatory hurdles, the company is poised to make a lasting impact in the biopharmaceutical industry.
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.
Liquidia Corporation (NASDAQ: LQDA) will report its second quarter 2021 financial results on August 10, 2021. A conference call and webcast are scheduled for 8:30 a.m. EDT, where the company will discuss financial outcomes and provide a corporate update. Interested parties can access the call via telephone or the webcast available on Liquidia's website. The company focuses on developing treatments for pulmonary hypertension through its PRINT® Technology, with ongoing projects like LIQ861 and Treprostinil Injection.
On June 7, 2021, United Therapeutics Corporation (Nasdaq: UTHR) announced it is pursuing trade secret misappropriation claims against Liquidia Technologies, Inc. (Nasdaq: LQDA) and a former employee. The lawsuit stems from evidence suggesting the employee took confidential documents to Liquidia during the development of LIQ861, a product competing with United Therapeutics' Tyvaso. The FDA's approval of LIQ861 is on hold pending the outcome of the litigation, which is scheduled for trial in March 2022. United Therapeutics seeks monetary and injunctive relief due to these allegations.
Liquidia Corporation (NASDAQ: LQDA) announced on June 2, 2021, that the FDA accepted its New Drug Application (NDA) resubmission for LIQ861, an inhalation powder for treating pulmonary arterial hypertension (PAH). The resubmission is a complete, class 2 response to a prior FDA action letter from November 24, 2020. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of November 7, 2021, for potential approval. However, final approval may be subject to ongoing legal issues with United Therapeutics and a regulatory stay that ends in October 2022.
Liquidia Corporation (NASDAQ: LQDA) announced that CEO Damian deGoa will present at the Jefferies Virtual Healthcare Conference on June 2, 2021, from 2:30 to 2:55 p.m. EDT. The session aims to provide an overview and update on the company's business strategies and developments. Investors and interested parties can access the live webcast through the Liquidia website, and an archived version will be available for 90 days post-event. Liquidia is focused on developing treatments for pulmonary hypertension using its proprietary PRINT® Technology.
Liquidia Corporation announced the availability of Sandoz Treprostinil Injection, a generic version of Remodulin®, for both subcutaneous and intravenous administration to treat pulmonary arterial hypertension (PAH). This is the first fully-substitutable generic option, providing lower-cost treatment alternatives. The RG 3ml Medication Cartridge has been cleared by the FDA, allowing for the SC administration of the medication, previously restricted. Liquidia aims to maintain high support levels while offering competitive pricing for patients.
Liquidia Corporation (NASDAQ: LQDA) announced a significant market expansion for Treprostinil Injection due to the introduction of subcutaneous delivery, nearly doubling its addressable market. The company also resubmitted its NDA for LIQ861 (treprostinil) Inhalation Powder to the FDA, aiming for a six-month review. Financially, they improved their position with a private placement raising $21.7 million and new credit facilities. First-quarter revenue stood at $3.1 million compared to none last year, and a net loss of $9.2 million was reported.
Liquidia Corporation (NASDAQ: LQDA) has resubmitted its New Drug Application (NDA) for LIQ861, targeting pulmonary arterial hypertension (PAH). The FDA issued a Complete Response Letter (CRL) in November 2020, citing incompleteness. Following a Type A meeting in January, the new NDA now includes additional chemistry and manufacturing details, but no new clinical data was required. The FDA plans to classify this resubmission as a Class 2, which entails a six-month review cycle. Liquidia is ready for required on-site inspections delayed by COVID-19.
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