Liquidia Corporation (NASDAQ:LQDA) has received a significant legal win as U.S. District Court Judge Andrews has vacated a previous injunction, opening the door for the Food and Drug Administration (FDA) to potentially grant final approval for its new drug, YUTREPIA™ (treprostinil) inhalation powder.

This development comes after the injunction, placed in August 2022 amidst litigation with United Therapeutics (UTHR), was lifted, marking a crucial step forward for Liquidia in the competitive pharmaceutical landscape.

YUTREPIA, which targets the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), had received tentative FDA approval in November 2021.

The drug's broader application, including the PH-ILD indication, had been pending due to an exclusivity period granted to Tyvaso® that expired on March 31, 2024.

With this expiration, the FDA can now take final action on YUTREPIA’s New Drug Application (NDA) for both medical conditions.

Dr. Roger Jeffs, CEO of Liquidia, expressed optimism about the drug's prospects, highlighting the company's readiness for the drug's market launch and its potential to become a preferred prostacyclin therapy due to its convenience and dosing flexibility.

However, United Therapeutics has not backed down, filing a notice of appeal against the decision to lift the injunction and pursuing additional legal avenues to prevent YUTREPIA's launch, specifically for treating PH-ILD.

These efforts include a lawsuit against the FDA to block Liquidia’s amended NDA and a separate action alleging patent infringement.

Despite these challenges, a recent ruling denied United Therapeutics' motion for a temporary restraining order and preliminary injunction against the FDA's approval process, setting a status conference to reassess UTHR’s claims after the FDA's decision on YUTREPIA.