Why Is Liquidia Stock Falling In Pre-market?

(RTTNews) - Liquidia (LQDA) announced the FDA has granted tentative approval of YUTREPIA inhalation powder to treat adults with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. The company noted that the tentative approval indicates that YUTREPIA has met all regulatory standards but must await the expiration of regulatory exclusivity of a competing product before final approval can be granted. The final approval of YUTREPIA for PAH and PH-ILD may occur after expiration of 3-year regulatory exclusivity for Tyvaso DPI on May 23, 2025.

Roger Jeffs, CEO, said: "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. 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."

Shares of Liquidia are down 22% in pre-market trade on Monday.

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