Liquidia Corporation, a pharmaceutical company specializing in the development of products based on its proprietary PRINT technology, is contending with a new legal challenge. United Therapeutics (NASDAQ:UTHR) Corporation has filed cross-claims against the U.S. Food and Drug Administration (FDA), reasserting its challenge to the FDA's acceptance of Liquidia's New Drug Application (NDA) for YUTREPIA (treprostinil) inhalation powder.
This development, disclosed in a Form 8-K filed with the SEC on Monday, September 16, 2024, follows United Therapeutics' voluntary dismissal of a previous complaint against the FDA regarding the same matter on August 20, 2024.
United Therapeutics' new cross-claims were filed in the U.S. District Court of the District of Columbia as part of an ongoing lawsuit initiated by Liquidia on August 21, 2024. The lawsuit by Liquidia challenged the FDA's decision to grant a 3-year new clinical investigation exclusivity to Tyvaso DPI, a competing product.
Liquidia, headquartered in Morrisville, North Carolina, has expressed its intention to vigorously defend its position and its ability to launch YUTREPIA. The outcome of this legal battle could have significant implications for both companies and the pharmaceutical market for treatments in their respective therapeutic area.
The financial implications of the lawsuit and the potential market impact of YUTREPIA's approval or delay remain to be seen. Liquidia Corporation is listed on The Nasdaq Stock Market LLC under the ticker symbol NASDAQ:LQDA.
In other recent news, United Therapeutics faced a legal setback in a case brought by Liquidia Corporation. The United States District Court for the District of New Jersey ruled in favor of Liquidia, regarding the launch of a generic version of Treprostinil Injection. The court found United Therapeutics' interference resulted in losses exceeding $137 million. The damages awarded are not yet final and may be subject to appeal.
In other developments, Liquidia secured approximately $100 million for cardiopulmonary drug development. This funding will support the development of YUTREPIA™ (treprostinil) inhalation powder and other clinical trials.
Furthermore, Liquidia has initiated legal proceedings against the FDA over the agency's grant of a 3-year new clinical investigation exclusivity to United Therapeutics' drug Tyvaso DPI®. This has delayed the approval of Liquidia's own treatment, YUTREPIA™.
Amid these developments, analyst firms such as H.C. Wainwright, BofA Securities, Jefferies, and BTIG have adjusted their stock price targets for Liquidia, while Goldman Sachs retained a Neutral rating for United Therapeutics.
Lastly, Liquidia reported a decrease in revenue to $3.7 million in Q2 2024, down from $4.8 million in the previous year's quarter, but maintains a cash reserve of $133 million.
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