Investigation Overview
An investigation on behalf of investors of MannKind Corporation (NASDAQ:MNKD) over possible violations of Federal Securities Laws by MannKind Corp and others was announced.
The investigation by a law firm concerns a lawsuit filed by MannKind's former senior director for regulatory affairs John Arditi. The former Senior Director of Regulatory Affairs accuses MannKind Corporation of covering up potential fraud in clinical trials for a new diabetes treatment. In his lawsuit the former employee claims MannKind Corporation withheld from regulators information about potential scientific misconduct at clinical trial sites in Russia and Bulgaria and that he was fired by MannKind Corporation after discovering possible fraud in studies for the drug, Afrezza. He alleges violation of the New Jersey Conscientious Employee Protection Act, wrongful discharge, breach of contract, breach of the implied covenant of good faith and fair dealing, and intentional infliction of emotional distress.
MannKind Corporation reported over the four past years a Net Loss of $230.55million in 2006, $292.19million in 2007, $303.04million in 2008, and $220.10million in 2009. During the first three quarters in 2010 MannKind Corporation reported a Net Loss of $40.60million, $37.36million, and $42.54million or a combined 9month Total Net Loss of $120.50million
Shares of MannKind Corporation traded during 2006 as high as $21.25 per share. During 2007 MNKD shares fell to $8 at the end of 2007 and dropped in 2008 to almost $2 per share. During 2009 MNKD shares were able to regain value and traded in Fall 2009 at over $10 per share. During the first months in 2010 MNKD shares were able to hold the Fall 2009 price level. But in March MNKD shares fell from $10 to under $7 in response to the receival of a letter from the FDA regarding the New Drug Application (NDA) for AFREZZA(TM) (insulin human [rDNA origin]) Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes mellitus for the control of hyperglycemia.
Then on April 23, 2010 MannKind Corporation announced that a study shows AFREZZA(R) controls blood Sugar Levels in Type 1 Diabetes, Results in Weight Loss, Less Hypoglycemia Than Usual Care. Shares of MannKind Corporation continued to loose value and traded as low as under $5 per share in May 2010. Then on June 10,2010 MannKind Corporation said that AFREZZA Demonstrates Non-Inferiority Compared to Standard Therapy in Controlling Blood Sugar Levels in Type 1 Diabetes Patients. Shares of MannKind Corporation started to begin to regain value und reached in the end of July again over $7 per share. MNKD shares continued to hold value until the beginning of August before they lost again and traded in the end of August at $5.55 per share. During September and October MNKD shares were able to surpass almost $7, but MNKD shares dropped from over $6.20 Nov. 3rd to as low as $5.20 on Nov. 4th after the news about the lawsuit former Senior Director of Regulatory Affairs was made public.
The U.S. Food and Drug Administration was set to rule on the biotech MannKinds diabetes treatment by December 29 and during December 2010 shares of MannKind Corporation (NASDAQ:MNKD) rose from $6.28 to over $8 per share. But then on December 28, MannKind Corporation announced that it was informed on December 27, 2010 by the FDA that the agency will not be able to complete the review of the New Drug Application for AFREZZA(R) (insulin human [rDNA origin]) Inhalation Powder by the action date of December 29, 2010. On January 19, 2011 MannKind Corporation (Nasdaq: MNKD) announced that it has received a complete response letter from the FDA regarding the New Drug Application for AFREZZA(R) (insulin human [rDNA origin]) Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyperglycemia. MannKind Corp said that a complete response letter is issued by the FDA's Center for Drug Evaluation and Research when the review of a file is completed but questions remain that preclude the approval of the NDA in its current form.
Shares of MannKind Corp., which traded on January 18, 2011 as high as almost $10 fell within 10 days to $5.05 per share on January 28, 2011.