Why MannKind (MNKD) Has Not Received FDA Approval For Its Product?

In the first half of the last 30 days, the price dropped 6% from $ 4.51 to $ 4.23. Over the next fortnight, the worth rallied and by October 14, the stock was worth $5.4, showing a 27.6% gain over that period. At the time of writing, the cost was $ 5.09. MannKind is a biopharmaceutical company that develops, manufactures, and supplies drugs for the treatment of lung diseases, namely endocrine and orphan sicknesses.

The company is partnering with United Therapeutics to develop Treprostinil (Tyvaso DPI) to combat pulmonary arterial hypertension. According to the company, the FDA didn’t approve this product, which came about as a result of the cooperation of the aforementioned companies. They received a complete response letter, which said of the flaw and, accordingly, the reason for which it was disapproved. The problem was related to the open issue of verification at a third-party analytical center for testing the drug substance treprostinil, the main ingredient in Tyvaso DPI.