MannKind Corp MNKD is trading significantly lower Monday morning after the company announced the FDA issued a complete response to United Therapeutics regarding the New Drug Application for Tyvaso DPI.
The FDA declined to approve the New Drug Application, citing a deficiency related to an open inspection issue at a third-party analytical testing center for treprostinil drug substance, the active ingredient of Tyvaso DPI.
Tyvaso DPI is intended for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
“We continue to build pre-launch inventory of Tyvaso DPI and look forward to supporting United Therapeutics’ efforts in securing approval of Tyvaso DPI in the coming months,” said Michael Castagna, CEO of MannKind.
MannKind is a biopharmaceutical company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension.
MNKD Price Action: MannKind has traded as high as $6.25 and as low as $1.87 over a 52-week period.
The stock was down 16.50% at $4.25 at time of publication.
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