Liquidia files suit challenging FDA decision

North Carolina, USA-based biopharma firm Liquidia Corporation (Nasdaq: ALQDA) announced Thursday that it has filed litigation in the US District Court of the District of Columbia (Case No. 1:24-cv-02428) that challenges the recent decision by the US Food and Drug Administration (FDA) to grant three-year new clinical investigation (NCI) exclusivity to Tyvaso (treprostinil) DPI.9.6.

Liquidia’s shares – which have slumped more than 31% in the last four days - closed down a further 3.5% to $9.63 following the announcement.

The FDA granted tentative approval of Yutrepia(treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) patients on August 16, 2024. As a result of the FDA’s award of NCI exclusivity to United Therapeutics’ (Nasdaq: UTHR) Tyvaso DPI, the final approval of Yutrepia (treprostinil) inhalation powder is currently delayed until after the expiration of the exclusivity on May 23, 2025.