Liquidia Corporation Wins Favorable Ruling Against United Therapeutics

Liquidia Corporation (NASDAQ: LQDA) recently announced a favorable ruling from the U.S. District Court for the District of Delaware. The court denied United Therapeutics' (UTHR) motion for a preliminary injunction to block the launch of Yutrepia™ (treprostinil) inhalation powder to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD). This ruling reinforces a clear path for the U.S. Food and Drug Administration (FDA) to issue a final decision on the amended New Drug Application (NDA) for Yutrepia.

The lawsuit filed by UTHR in September 2023 alleged that Yutrepia would infringe U.S. Patent No. 11,826,327 ('327 patent). The recent ruling maintains the status quo, allowing the FDA to grant final approval to Yutrepia. However, the lawsuit is set to continue to trial, scheduled for June 2025.

Earlier legal rulings from multiple bodies found that Yutrepia does not infringe any valid claim of the patents previously asserted by UTHR. This includes a decision by the Patent Trial and Appeal Board, affirmed by the U.S. Court of Appeals for the Federal Circuit, that all claims of U.S. Patent No. 10,716,793 ('793 patent) were unpatentable.

Yutrepia, an investigational, inhaled dry powder formulation of treprostinil, received tentative FDA approval for the pulmonary arterial hypertension (PAH) indication in November 2021. It was designed using Liquidia's Print® technology, which enables the development of precise and uniform drug particles engineered for enhanced deposition in the lung following oral inhalation.

Liquidia is intensifying its commercial preparations for Yutrepia while awaiting final FDA action. The company is also conducting clinical studies, including the ASCENT trial, to evaluate the safety and tolerability of dry powder inhaled treprostinil in patients with PH-ILD.

Liquidia Corporation, a biopharmaceutical company, is focused on the development and commercialization of products in pulmonary hypertension and other applications of its Print® technology. The company operates through its two wholly-owned subsidiaries, Liquidia Technologies, Inc. and Liquidia PAH, LLC.

The recent ruling represents a significant development for Liquidia Corporation as it continues its efforts to bring Yutrepia to market for the treatment of both PAH and PH-ILD, pending final FDA approval. Following these announcements, the company's shares moved 12.8%, and are now trading at a price of $14.52. For the full picture, make sure to review Liquidia's 8-K report.

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