Legal Victory for Liquidia in Dispute with United Therapeutics

By Tamara Parker • Monday, May 05 10:10 • Permanent Link

Liquidia Corporation (NASDAQ: LQDA) has recently announced a significant development in its legal dispute with United Therapeutics (UTHR) regarding the new drug application (NDA) for Yutrepia™ (treprostinil) inhalation powder. The U.S. District Court for the District of Columbia has dismissed UTHR's cross-claim, challenging Liquidia's amendment to the NDA for Yutrepia, without prejudice. The court ruled that UTHR's claim was unripe and that UTHR had failed to plausibly allege standing.

This development comes as the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for the Yutrepia NDA of May 24, 2025. Liquidia's CEO, Dr. Roger Jeffs, expressed satisfaction with the court's decision, emphasizing the company's focus on the potential final approval of Yutrepia following the expiration of gating regulatory exclusivity on May 23, 2025.

Liquidia's lead candidate, Yutrepia, is an investigational drug for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company remains committed to the development and commercialization of products in pulmonary hypertension and other applications of its proprietary Print® technology.

It's worth noting that UTHR has the right to appeal the court's ruling, and the company is optimistic about the potential final approval of Yutrepia, aiming to become the prostacyclin of first choice for patients with PAH and PH-ILD, as well as the physicians who treat them.

As of now, the focus remains on the upcoming PDUFA goal date, marking a crucial milestone in the regulatory process for Yutrepia. Liquidia's dedication to developing innovative therapies for patients with rare cardiopulmonary disease is evident as it continues to navigate the regulatory landscape and legal challenges in the pursuit of potential treatment options for patients in need. As a result of these announcements, the company's shares have moved 0.7% on the market, and are now trading at a price of $15.94. Check out the company's full 8-K submission here.

The above analysis is intended for educational purposes only and was performed on the basis of publicly available data. It is not to be construed as a recommendation to buy or sell any security. Any buy, sell, or other recommendations mentioned in the article are direct quotations of consensus recommendations from the analysts covering the stock, and do not represent the opinions of Market Inference or its writers. Past performance, accounting data, and inferences about market position and corporate valuation are not reliable indicators of future price movements. Market Inference does not provide financial advice. Investors should conduct their own review and analysis of any company of interest before making an investment decision.