MannKind Corporation (NASDAQ:MNKD) Files NDA Target Drug Called Afrezza


Dallas, Texas 10/17/2013 (Financialstrend) – The development stage biotech and drug manufacturing firm MannKind Corporation (NASDAQ:MNKD) has filed an update with SEC listing out details of the reworked new drug application it has filed with U.S. Food and Drug Administration. The NDA is for target drug called Afrezza. The application has been appended with all data collected from the trial of its “inhalable insulin” treatment procedure. The program has been code named AFFINITY and involves administering Afrezza drug in a inhalable form to people undergoing treatment for high blood sugar levels.

The $1.53 billion bio tech company has sought FDA approval to market “AFREZZA (insulin human [rDNA origin])” in the form of an inhalable powder. This mode of treatment with AFREZZA is expected to help patients suffering from type1 or type2 diabetes to control glycemic level in their blood. The drug firm has submitted what it calls positive results that it was able to generate from two Phase 3 trials. In the first phase 3 trial, 171 patients with type 1 diabetes were administered this inhalable drug while in  the second phase 3 trial, 175 patients suffering from type 2 diabetes were made to undergo this test.

On the back of this announcement, stock shot up by 4.47% in a single day during trading yesterday. At close of business on October 16, the share price was $5.37 which represents a 195% increase over its 52 week low pricing. While the share price picked up, the volume of shares that got transacted almost halved in comparison to its daily trading average.

Investors in the stock would be hoping that post the announcement the strong rally would continue to levels which will meet the PT of 7.46 per share that analysts have forecasted. The stock has seen its value go up by 13.29% in the past week’s trading