MannKind - United Therapeutics' Formulated Treprostinil Under FDA Review For Pulmonary Hypertension - MannKind (NASDAQ:MNKD), United Therapeutics (NASDAQ:UTHR)

MannKind Corporation MNKD and United Therapeutics Corporation 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.