MORRISVILLE, N.C. - Liquidia Corporation (NASDAQ: LQDA) has announced significant legal advancements that may pave the way for the launch of its drug candidate YUTREPIA™ (treprostinil) inhalation powder, intended for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). On Monday, the company reported that a U.S. District Court judge had lifted an injunction that previously blocked the Food and Drug Administration (FDA) from giving the drug final approval.
The injunction, originally put in place in August 2022 as part of the Original Hatch-Waxman Litigation, was removed by Judge Andrews on March 28. This development followed a denied motion by United Therapeutics (NASDAQ:UTHR) for a temporary restraining order and preliminary injunction against the FDA, which was seeking to prevent approval of Liquidia's New Drug Application (NDA) for YUTREPIA.
United Therapeutics has filed an appeal against the decision to lift the injunction and has initiated separate litigation to secure new injunctions to prevent the launch of YUTREPIA for treating PH-ILD. However, these legal challenges are not expected to hinder the drug's launch unless United Therapeutics succeeds in obtaining the relief it seeks.
YUTREPIA has already received tentative FDA approval for PAH in November 2021, and Liquidia amended its NDA in July 2023 to include the PH-ILD indication. With the expiration of Tyvaso®'s regulatory exclusivity for treating PH-ILD on March 31, 2024, the FDA is now in a position to finalize its decision on YUTREPIA's amended NDA for both indications.
Dr. Roger Jeffs, CEO of Liquidia, expressed optimism about the potential of YUTREPIA, highlighting its convenient delivery system and broad dosing range as key differentiators that could position it as a preferred prostacyclin therapy.
YUTREPIA utilizes Liquidia's proprietary PRINT® technology to create uniform drug particles designed for enhanced lung deposition following oral inhalation. The drug has been evaluated in clinical studies for PAH and is currently under investigation in the ASCENT trial to assess its safety and tolerability in patients with PH-ILD.
Liquidia Corporation specializes in developing products for pulmonary hypertension and leverages its PRINT® Technology across its product pipeline. The company's focus extends to other applications of this technology, with the aim of improving patient outcomes in various therapeutic areas.
This news is based on a press release statement from Liquidia Corporation.
InvestingPro Insights
As Liquidia Corporation (NASDAQ: LQDA) makes headway in the legal landscape, potentially clearing a path for YUTREPIA™, its financials and market performance offer additional context for investors monitoring the company's progress. According to InvestingPro data, Liquidia boasts a market capitalization of $1.12 billion, reflecting investor confidence amidst recent developments. While the company's price-to-earnings (P/E) ratio stands at -12.19, indicating that it is not currently profitable, the PEG ratio of 0.18 suggests that analysts expect significant earnings growth in the future relative to the share price.
The company's strong revenue growth of 9.75% in the last twelve months as of Q4 2023 is a positive signal for investors looking at its sales trajectory. However, it's important to note that Liquidia is trading at a high Price / Book multiple of 23.71, which could imply that its assets are being valued quite optimistically by the market. This optimism may be partly justified by the company's impressive gross profit margin of 83.49% in the same period, showcasing its ability to retain a significant portion of its revenue as profit after accounting for the cost of goods sold.
From an investment perspective, two particular InvestingPro Tips stand out: analysts anticipate sales growth in the current year and the company's liquid assets exceed short-term obligations. These insights suggest that despite the lack of profitability in the past twelve months, Liquidia has the financial resilience to meet its immediate financial obligations and is expected to grow its sales. Additionally, the company has demonstrated a strong return over the last year, with a 113.46% price total return, which could be indicative of positive market sentiment.
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