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

·1 min read
  • 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.

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