The FDA was scheduled to issue a decision on Mannkind's inhaled insulin, Afrezza, on December 29. However it subsequently has stated that it needs another four weeks to finalize the evaluation process and issue a decision. The decision could be released at anytime.
There is much speculation as to why the delay happened. It is my belief that Afrezza will be approved and the delay is due to determining the final label for Afrezza and establishing the guidelines for any post approval REMS programs that the FDA may require.
Approval should move the share price to the $15.00-$20.00 range. A subsequent big pharma partnership could add another $10.00 to the share price.
Almost 35% of the float is shorted: 20,000,000 shares
Mannkind’s current market cap is just over one billion dollars.
In addition to Afrezza, Mannkind also has a very promising cancer vaccine in trials.
Al Mann, the billionaire CEO of Mannkind, has a proven track record of success. He has personally invested over a billion dollars of his personal fortune in Mannkind. Within recent months he purchased another 1,400,000 shares of stock in the company and currently owns almost 45% of the company.
Mannkind may be one stock that you might want to buy at the market open on January 3. It’s quite likely that the share price will reach the $10.00 range prior to the announcement of the FDA’s decision.