MNKD - United Therapeutics MannKind gain as FDA approve lung disease therapy

Commercial-stage biotech, United Therapeutics (NASDAQ:UTHR) and its partner MannKind (MNKD) are trading sharply higher on Monday after the FDA announced the approval of their lung disease therapy Tyvaso DPI. Accordingly, the drug-device combination is authorized to treat the pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease to improve exercise ability, the federal agency said. Early this year, the FDA requested United Therapeutics (UTHR) to provide additional information regarding the pulmonary safety of Tyvaso DPI following a pending Citizen Petition filed against its marketing application. With the approval, the regulator has declined the Citizen Petition.

For further details see:

United Therapeutics, MannKind gain as FDA approve lung disease therapy