Liquidia (LQDA) Down on FDA Delaying Full Approval for Yutrepia

Core Points - Liquidia Corporation (LQDA) shares fell nearly 31% after the FDA delayed full approval for its Yutrepia inhalation powder for lung disorders [1] - The FDA granted tentative approval for Yutrepia for pulmonary hypertension associated with interstitial lung disease (PH-ILD) and previously for pulmonary arterial hypertension (PAH) in 2021 [1][2] - Final approval for Yutrepia may be delayed until after the three-year regulatory exclusivity for United Therapeutics' Tyvaso Dry Powder Inhaler (DPI) expires on May 23, 2025 [2] - Liquidia plans to challenge the three-year exclusivity to expedite patient access to Yutrepia [3] - Liquidia's stock has decreased 18.6% year-to-date, compared to a 1.7% decline in the industry [3] - Ongoing patent litigation exists between Liquidia and United Therapeutics regarding Yutrepia [4] - The tentative approval is based on data from the phase III INSPIRE study, which indicated Yutrepia is safe and well-tolerated [5] Industry Context - United Therapeutics' stock rose 8.6% following the FDA's announcement regarding Yutrepia [2] - Liquidia currently holds a Zacks Rank 3 (Hold), while Arcturus Therapeutics and Fulcrum Therapeutics have better rankings of 1 (Strong Buy) [6] - Arcturus Therapeutics has seen improvements in loss per share estimates for 2024 and 2025, despite a year-to-date stock decline of 32.1% [7] - Fulcrum Therapeutics has improved loss per share estimates for 2024 and 2025, with a year-to-date stock increase of 38.4% [8]