MannKind Corporation suffered a blow this morning, with the market not reacting kindly to the FDA’s declination of their New Drug Application (NDA) for Tyvaso DPI – a new drug for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension in regards to interstitial lung disease.
Following the early morning public release, MannKind stock has seen a sharp 20% sell-off in reaction to the news. The company – specialists in the development and commercialization of inhalable therapeutic products for those suffering from endocrine and orphan lung diseases – has recorded noticeable gains over the last year, only to be hit hard with this morning’s NDA denial.
Unfortunately for Mannkind and its stakeholders, the NDA was declined by the FDA based on a ‘deficiency’ relating to an open inspection problem at one of the third-party analytical testing centers – more specifically, for treprostinil drug substance, the active ingredient in the anticipated drug Tyvaso DPI.
Michael Castagna, CEO of MannKind Corporation remains optimistic:
“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”
Although the FDA issued a firm blow to MannKind stock, the company still looks to stay on its upwards trend. With work in place to ensure Tyvaso DPI is approved in the near future, this could prove as a mere pinprick in the company’s overall growth model.
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