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Liquidia Corporation - LQDA STOCK NEWS

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.

Liquidia Corporation (NASDAQ: LQDA) is a U.S.-based biopharmaceutical company committed to enhancing drug delivery and efficacy through its proprietary PRINT® technology. The company focuses on the development, manufacturing, and commercialization of innovative therapies for pulmonary hypertension (PH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Liquidia’s flagship product, YUTREPIA™, is an investigational inhaled dry powder formulation of treprostinil designed to treat pulmonary arterial hypertension (PAH) and PH-ILD. This product aims to improve exercise ability and quality of life for patients.

Liquidia is actively advancing its product pipeline, which includes L606, an investigational sustained-release formulation of treprostinil administered through a next-generation nebulizer. Currently, L606 is under evaluation in an open-label study and aims to extend drug exposure while minimizing local irritation in the lungs.

In addition to these developments, Liquidia has a valuable collaboration with leading pharmaceutical companies, leveraging its PRINT® technology for broader therapeutic areas. This technology enables precise production of uniform drug particles, enhancing safety and efficacy, and can be applied to various therapeutic areas and routes of administration.

Recent achievements include the promotion of key leadership within the company as they prepare for the potential FDA approval and launch of YUTREPIA. The company has also successfully navigated regulatory and legal challenges, ensuring a clear path for YUTREPIA’s market entry.

Financially, Liquidia has demonstrated robust growth, reporting significant revenue from its partnership with Sandoz for the commercial sale of Treprostinil Injection. The company has also secured substantial funding through strategic agreements, bolstering its cash reserves for continued research and development efforts.

Liquidia remains dedicated to transforming patient care by addressing unmet needs with innovative drug delivery solutions and is poised to make significant strides in the biopharmaceutical industry.

News

FDA Accepts Submission to Add PH-ILD to YUTREPIA™ Label

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Liquidia Corporation's amendment for YUTREPIA's new drug application has been accepted by the FDA for review. If approved, YUTREPIA would be indicated for the treatment of both pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA has set a PDUFA goal date of January 24, 2024. The addition of the PH-ILD indication does not require new clinical studies. However, the launch of YUTREPIA is subject to ongoing litigation with United Therapeutics and final FDA approval. The FDA may not grant final approval for the PH-ILD indication until after the expiration of new clinical investigation exclusivity granted to Tyvaso on March 31, 2024.
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United Therapeutics Corporation Files Lawsuit Alleging Infringement of Tyvaso Patent Already Found to Be Invalid by U.S. Patent Office

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Liquidia Corporation faces patent infringement action by United Therapeutics Corporation under the Hatch-Waxman Act in response to Liquidia's amendment to its NDA for YUTREPIA. The '793 patent, previously ruled invalid by the PTAB, is asserted in the litigation, triggering a regulatory stay on FDA's final approval of YUTREPIA. The appeal of the PTAB decision is expected to be completed in Q4 2023 or H1 2024.
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Liquidia Corporation Reports Second Quarter 2023 Financial Results and Provides Corporate Update

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Liquidia Corporation reports financial results for Q2 2023, including advancements in their mission to become the leading inhaled treprostinil provider for pulmonary hypertension patients. The company also provides updates on ongoing litigation, an amendment to add PH-ILD indication to their drug application for YUTREPIA, and a partnership to develop L606. Financially, the company's cash totaled $88.2 million as of June 30, 2023, and revenue increased to $4.8 million compared to the same period last year.
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Liquidia Corporation to Report Second Quarter 2023 Financial Results on August 10, 2023

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Liquidia Submits Amendment to Add PH-ILD Indication to Tentatively Approved NDA for YUTREPIA™ (treprostinil) Inhalation Powder

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Liquidia Corporation (LQDA) submits an amendment to the NDA for YUTREPIA to add PH-ILD indication without requiring new clinical data. Recertifies that YUTREPIA does not infringe any valid patents listed in the Orange Book for Tyvaso. Potential launch of YUTREPIA between end of 2023 to mid-2024.
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U.S. Federal Circuit Affirms All District Court Rulings in Patent Litigation

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Liquidia Corporation (NASDAQ: LQDA) has received a favorable ruling from the Court of Appeals for the Federal Circuit, affirming all rulings by the United States District Court for the District of Delaware in the litigation filed by United Therapeutics (UTHR). The case focused on the infringement of U.S. Patent No. 10,716,793 ('793 Patent) by Liquidia's YUTREPIA™ (treprostinil) inhalation powder. The ruling does not affect the previous decision by the Patent Trial and Appeal Board (PTAB) that all claims in the '793 patent are unpatentable, which was re-affirmed in February 2023. Liquidia will now seek final regulatory approval for YUTREPIA pending the appeal of the '793 IPR decision by the Federal Circuit.
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Liquidia Corporation and Pharmosa Biopharm Announce Collaboration for Sustained-Release Inhaled Treprostinil Product in North America

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Liquidia Corporation to Present at the 2023 Jefferies Healthcare Conference

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Liquidia Announces Poster Presentation at the 2023 American Thoracic Society International Conference

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Liquidia Corporation Reports First Quarter 2023 Financial Results and Provides Corporate Update

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Liquidia Corporation reported financial results for Q1 2023, with revenue of $4.5 million, a 28.6% increase from Q1 2022. Cash totaled $94.4 million as of March 31, 2023. The company secured access to additional capital with revenue interest financing, with the potential to receive up to $100 million. Liquidia also provided updates on legal appeals related to patent litigation. Net loss for Q1 2023 was $11.7 million, compared to $15.9 million in Q1 2022.
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FAQ

What is the current stock price of Liquidia Corporation (LQDA)?

The current stock price of Liquidia Corporation (LQDA) is $11.1 as of December 20, 2024.

What is the market cap of Liquidia Corporation (LQDA)?

The market cap of Liquidia Corporation (LQDA) is approximately 912.4M.

What is Liquidia Corporation's primary focus?

Liquidia Corporation focuses on developing, manufacturing, and commercializing innovative therapies for pulmonary hypertension and pulmonary hypertension associated with interstitial lung disease using its proprietary PRINT® technology.

What is YUTREPIA?

YUTREPIA is an investigational inhaled dry powder formulation of treprostinil designed to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

What is PRINT® technology?

PRINT® technology is Liquidia's proprietary particle engineering platform that enables the precise production of uniform drug particles, enhancing safety and efficacy and applicable to various therapeutic areas and routes of administration.

What products are in Liquidia’s pipeline?

In addition to YUTREPIA, Liquidia is developing L606, an investigational sustained-release formulation of treprostinil administered through a next-generation nebulizer.

How does Liquidia generate revenue?

Liquidia generates revenue primarily from the sale of Treprostinil Injection through a partnership with Sandoz, as well as through strategic collaborations leveraging its PRINT® technology.

What recent leadership changes have occurred at Liquidia?

Recent leadership changes include the promotion of Michael Kaseta to Chief Operating Officer in addition to his role as Chief Financial Officer, and Michael Hunter to Senior Vice President of Manufacturing Operations.

What is the current status of YUTREPIA’s FDA approval?

YUTREPIA has received tentative approval from the FDA for the treatment of PAH, and Liquidia has filed an amendment to include PH-ILD. The FDA is expected to take final action on the amended NDA.

What are the financial highlights for Liquidia?

Liquidia reported significant revenue growth from its partnership with Sandoz, increased research and development expenses focused on YUTREPIA and L606, and strengthened cash reserves through strategic funding agreements.

What legal challenges has Liquidia faced?

Liquidia has navigated patent litigation and regulatory challenges, recently overcoming an injunction that had prevented FDA approval of YUTREPIA, and is actively defending against ongoing patent infringement claims.

How can I learn more about Liquidia Corporation?

For more information, visit Liquidia's official website at www.liquidia.com.

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Liquidia Corporation

Nasdaq:LQDA

LQDA Rankings

#2617 Ranked by Market Cap
N/A Ranked by Dividends

LQDA Stock Data

912.38M
60.46M
19.49%
54.31%
12.25%
Biotechnology
Pharmaceutical Preparations
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United States of America
MORRISVILLE