MannKind (NASDAQ:MNKD) stock is taking a beating on Monday after releasing an update to investors concerning news from the U.S. Food and Drug Administration (FDA).
That update has to do with the company’s New Drug Application (NDA) for Tyvaso DPI for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
According to the company, the FDA’s complete response to the filing has it withholding approval for the drug. The issue with the filing has to do with “a third-party analytical testing center for treprostinil drug substance.” This is the active ingredient in Tyvaso DPI.
MannKind makes sure to point out that the complete response isn’t connected directly to it. That means it doesn’t affect any of the operations at its facility or the device connected to the drug.
Michael Castagna, PharmD, CEO of MannKind, said the following about today’s news hammering MNKD stock.
“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.”
MNKD stock is under heavy trading as a result of today’s news. That has some 11 million shares of the stock changing hands as of this writing. To put that in perspective, the company’s daily average trading volume comes in at about 2.6 million shares.
That heavy trading and the FDA news also have MNKD stock falling 17.8% as of Monday morning. However, MNKD stock is still up 30% since the start of the year.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
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