Liquidia’s stock $LQDA plummeted nearly 30% on Monday following the company’s announcement that while the FDA had granted a tentative approval for its treprostinil inhalation powder, it won’t get final approval until its competitor drug’s regulatory exclusivity is over in 2025.
The FDA handed down a tentative approval to Liquidia’s drug, Yutrepia, to treat adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The tentative approval means the drug met all the safety and efficacy requirements but can’t enter the market until United Therapeutics’ competing drug Tyvaso loses its regulatory exclusivity on May 23, 2025.
The FDA tentatively approved Yutrepia to treat PAH in 2021. Then last year, Liquidia amended its NDA to add the indication to treat PH-ILD as well as PAH.
Liquidia CEO Roger Jeffs said in a statement that “we are disappointed and disagree with the FDA’s decision to simultaneously grant regulatory exclusivity to United Therapeutics for Tyvaso DPI that encompasses chronic use of essentially any dry-powder formulation of treprostinil in the approved indications for a three-year period for its new dosage form approved on May 23, 2022.”
Jeffs added that the company plans to “take quick action to challenge the FDA’s broad grant of regulatory exclusivity.”
TD Cowen analysts wrote in a Monday note that they don’t expect a full approval for Yutrepia ahead of next May, given that FDA has likely given considerable thought to the application.
The analysts also called Liquidia’s announcement a relief for United investors — Tyvaso brought in $398.2 million in the second quarter of 2024 for United, which represents 25% growth from the same time last year. For the full year 2023, Tyvaso revenues were $1.2 billion, a 41% increase from 2022.
Liquidia and United have been locked in various court battles in the last several years over Yutrepia’s looming approval and patents.
In April, a federal judge in Delaware removed a 2022 injunction that was part of a patent lawsuit brought by United — the decision finally allowed the FDA to approve Liquidia’s NDA for Yutrepia. United also tried unsuccessfully to sue the FDA in order to stop the agency from approving Yutrepia in PH-ILD.