07:37 AM EDT, 08/19/2024 (MT Newswires) -- Liquidia ( LQDA ) said Monday it has received tentative US Food and Drug Administration approval for its drug Yutrepia for the treatment of adults with pulmonary arterial hypertension and pulmonary hypertension associated with lung disease.

The inhalation powder, also known as treprostinil, has met quality, safety, and efficacy requirements but awaits the 2025 expiration of the exclusivity period for United Therapeutics's (UTHR) Tyvaso DPI before gaining final approval, the company said.

The tentative approval of Yutrepia is based on findings from a phase 3 clinical trial, the company said.

Liquidia ( LQDA ) shares were down by nearly 38% in premarket trading, while United Therapeutics was up by more than 7%.

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