Why Is Pulmonary Hypertension-Focused Liquidia Stock Soaring Today?

Liquidia Corp LQDA stock jumped after a win in a patent dispute with United Therapeutics Corporation UTHR revolving around U.S. Patent 10,716,793 (the ’793 patent).

"We have considered United Therapeutics (UTC's) remaining arguments and find them unpersuasive," the three judge panel wrote in its decision. "For the reasons provided above, we affirm the Board's unpatentability determination."

United Therapeutics owns the ’793 patent, which is directed to treating pulmonary hypertension (PAH) and PAH-associated with interstitial lung disease by inhaling treprostinil, which United Therapeutics markets as Tyvaso.

In November 2021, the FDA issued a tentative approval of Yutrepia (treprostinil) inhalation powder, but it cannot yet be marketed, pending resolution of Hatch-Waxman litigation commenced by United Therapeutics in June 2020. 

In its Q3 earnings release, Liquidia said that the FDA accepted the amendment to the New Drug Application (NDA) for Yutrepia to add the indication of pulmonary hypertension associated with interstitial lung disease (PH-ILD) to the label and has set a Prescription Drug User Fee Act (PDUFA) goal date of January 24, 2024. 

Final approval of the PH-ILD indication cannot occur until the new clinical investigation exclusivity granted to Tyvaso expires on March 31, 2024. 

Price Action: LQDA shares are up 42.80% at $11.26, and UTHR stock is down 4.39% at $221.75 on the last check Wednesday.