Liquidia Corporation (NASDAQ:LQDA) delivered news on Thursday that the FDA has prolonged the review period pertaining to its proposal for expanding the indication of its drug-device combination, Yutrepia, in the United States.

In response to the company’s amendment to the New Drug Application (NDA) for the drug, the regulatory agency conceded that it would not be able to meet the previously announced January 24, 2024, target action date.

The FDA has verified the ongoing review process and has not made requests for additional data, yet it has refrained from disclosing a new Prescription Drug User Fee Act (PDUFA) goal date.

Yutrepia, which is an inhaled dry powder formulation of treprostinil, attained tentative FDA approval in 2021 for treating pulmonary arterial hypertension (PAH).

Liquidia (LQDA) filed submissions in 2023 to expand the NDA, seeking to introduce a new indication known as pulmonary hypertension associated with interstitial lung disease (PH-ILD).

The FDA’s decision unfolds amid an ongoing patent dispute linked to Yutrepia between LQDA and United Therapeutics (UTHR), the latter of which distributes its version of the treatment under the name Tyvaso.