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United Therapeutics (NASDAQ:UTHR) attempt for a preliminary injunction to stop the Food & Drug Administration from approving Liquidia’s (NASDAQ:LQDA) Yutrepia lung-disease drug was denied by a judge.
U.S. District Judge John D. Bates denied United Therapeutics (UTHR) request for a preliminary injunction and a temporary restraining order at a court hearing on Friday, according to a court filing.
United Therapeutics (UTHR) markets its version of treprostinil as Tyvaso, and the FDA granted tentative approval for a generic to Liquidia (LQDA) in 2021, allowing for its potential market entry as Yutrepia for PH-ILD as early as March. Yutrepia, like its more established competitor, Tyvaso, treats high blood pressure in the lungs.
With the preliminary injunction denied, the FDA can approve the PH-ILD indication after the regulatory exclusivity granted to Tyvaso (nebulized) expires on March 31.
On Thursday US District Judge Richard G. Andrews granted Liquidia’s (LQDA) motion for post-judgment relief, according to a court order. United Therapeutics (UTHR) motion for leave to file a two-page sur-reply was dismissed as moot. The court victory sent Liquidia (LQDA) shares up 5% in after-hours trading on Thursday.
“We believe Liquidia remains ready to launch Yutrepia,” BofA analyst Greg Harrison wrote in a March 13 note. “With a strong DPI market opportunity, we currently model $686M peak sales for Yutrepia in PAH and a launch in 2024. We continue to look for an FDA decision towards a full approval in PH-ILD to add the indication to our model.”