The shares of Liquidia Corporation (NASDAQ: LQDA) are currently experiencing an upward trend, witnessing an increase of 8.37% to $15.98 as of the most recent observation during the pre-market session today. Liquidia’s stock concluded the prior session with a decline of 2.12%, settling at $14.75. The present surge in LQDA’s stock price follows a notable regulatory approval advancement.
According to Liquidia (LQDA), on March 28, Judge Andrews of the U.S. District Court for the District of Delaware revoked the injunction that was granted in August 2022 in the case that United Therapeutics (UTHR) had brought.
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As a result, Liquidia’s New Drug Application (NDA) for YUTREPIA (treprostinil) inhalation powder is no longer subject to FDA restrictions and can be approved in its entirety. The latest decision by Judge Andrews has given Liquidia clear permission to seek final clearance for YUTREPIA.
Liquidia has sent the judge’s instruction to the FDA and is looking forward to hearing back from them soon. Its commercial team stands fully prepared to introduce YUTREPIA for both pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) should the FDA grant final approval.
Liquidia is confident that upon launch, the user-friendly administration and broad dosing range of YUTREPIA are poised to propel the therapy towards Liquidia’s objective of establishing it as the first-choice prostacyclin. YUTREPIA received tentative approval from the FDA for the treatment of PAH in November 2021. Liquidia subsequently amended its NDA in July 2023 to include the indication for treating PH-ILD.
The expiration of the new clinical investigation exclusivity granted to Tyvaso to treat PH-ILD on March 31, 2024, now enables the FDA to take conclusive action on YUTREPIA’s amended NDA, seeking approval for both indications. United Therapeutics has lodged a notice of appeal regarding Judge Andrews’ decision to revoke the injunction.
Furthermore, United Therapeutics has initiated two separate litigations in an attempt to secure new injunctions preventing the launch of YUTREPIA for PH-ILD treatment. For both of these measures, UTHR must demonstrate, among other criteria, a substantial likelihood of success on the merits and establish irreparable harm if the injunctions are not granted. None of these appeals or actions will obstruct Liquidia’s launch of YUTREPIA unless UTHR achieves the relief it seeks.
