Why Liquidia Corporation Shares Are Moving Lower Monday

Liquidia Corporation LQDA stock moved lower by more than 33% on Monday after the company announced that the Food and Drug Administration (FDA) granted tentative approval of YUTREPIA.

The Detail: YUTREPIA (treprostinil) inhalation powder received tentative approval for use in treating adults with pulmonary arterial hypertension and pulmonary hypertension related to interstitial lung disease.

YUTREPIA could gain final approval from the FDA once Tyvaso DPI’s regulatory exclusivity expires in May 2025.

“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,” said Roger Jeffs, CEO of Liquidia.

“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 provisional approval of YUTREPIA is founded on results from the Phase 3 INSPIRE trial, which assessed patients who were either new to treprostinil or transitioning from nebulized treprostinil to YUTREPIA. The findings indicated that YUTREPIA was safe and well-tolerated, irrespective of the patient’s prior exposure to treprostinil.

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LQDA Price Action: At the time of publication, Liquidia stock is trading at $10.13, according to data from Benzinga Pro.

Image: Unsplash/ Volodymyr Hryshchenko