Benzinga | Jun 16, 2021 07:26AM EDT

MannKind - United Therapeutics' Formulated Treprostinil Under FDA Review For Pulmonary Hypertension

* MannKind Corporation (NASDAQ:MNKD) and United Therapeutics Corporation (NASDAQ:UTHR) have announced that the FDA has accepted for review the marketing application of Tyvaso DPI (inhaled treprostinil).

* Under priority review status, the application seeks approval to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

* The agency's review will complete in October and indicated that they had not identified any potential review issues at this time.

* Tyvaso DPI is a next-generation dry powder formulation of Tyvaso. If approved, Tyvaso DPI is expected to provide a more convenient method of administration as compared with traditional nebulized Tyvaso therapy.

* Price Action: MNKD shares are up 11% at $4.55 during the premarket session on the last check Wednesday, while UTHR closed at $178.45 on Tuesday.