U.S. Markets closed
  • S&P Futures

    4,403.75
    -11.25 (-0.25%)
     
  • Dow Futures

    34,741.00
    -257.00 (-0.73%)
     
  • Nasdaq Futures

    15,089.50
    +43.25 (+0.29%)
     
  • Russell 2000 Futures

    2,196.90
    -22.50 (-1.01%)
     
  • Crude Oil

    68.47
    -2.09 (-2.96%)
     
  • Gold

    1,813.60
    -0.50 (-0.03%)
     
  • Silver

    25.47
    -0.11 (-0.44%)
     
  • EUR/USD

    1.1844
    -0.0024 (-0.2013%)
     
  • 10-Yr Bond

    1.2170
    +0.0330 (+2.79%)
     
  • Vix

    17.94
    -0.10 (-0.55%)
     
  • GBP/USD

    1.3900
    -0.0015 (-0.1070%)
     
  • USD/JPY

    109.4750
    +0.4250 (+0.3897%)
     
  • BTC-USD

    40,238.55
    +920.45 (+2.34%)
     
  • CMC Crypto 200

    996.98
    +21.08 (+2.16%)
     
  • FTSE 100

    7,123.86
    +18.14 (+0.26%)
     
  • Nikkei 225

    27,584.08
    -57.75 (-0.21%)
     

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

  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
·1 min read
In this article:
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
  • 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.

See more from Benzinga

© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.