Liquidia Corporation’s stock, trading under the ticker symbol LQDA, took a significant hit on Monday, plummeting by over 33%. This downturn followed the announcement that the Food and Drug Administration (FDA) had granted tentative approval to their drug YUTREPIA. YUTREPIA, a treprostinil inhalation powder, received this provisional approval for treating adults with pulmonary arterial hypertension and pulmonary hypertension related to interstitial lung disease. However, there’s a catch. The FDA simultaneously granted regulatory exclusivity to United Therapeutics for Tyvaso DPI, encompassing chronic use of any dry-powder formulation of treprostinil. This exclusivity period, lasting three years, effectively delays YUTREPIA’s full market entry until May 2025 when Tyvaso DPI’s exclusivity expires.
Liquidia’s CEO, Roger Jeffs, expressed disappointment and disagreement with the FDA’s decision. He stated, “We plan to take quick action to challenge the FDA’s broad grant of regulatory exclusivity and defend the ability for patients to have access to YUTREPIA with the least delay possible.”
The tentative approval of YUTREPIA is based on results from the Phase 3 INSPIRE trial. This trial evaluated the efficacy and safety of YUTREPIA in patients who were either new to treprostinil or transitioning from nebulized treprostinil to YUTREPIA. The study’s findings concluded that YUTREPIA was both safe and well-tolerated, regardless of the patient’s prior exposure to treprostinil.
The current stock price of Liquidia is $10.13, according to data from Benzinga Pro. The company’s plans to challenge the FDA’s decision will likely be closely watched by investors as the future of YUTREPIA hangs in the balance.
