MannKind Delay Causing Pain (MNKD)

October 6, 2009 · Filed Under Diabetes, fda 

MannKind Corp. (NASDAQ: MNKD) is very active with downside trading this morning.  There has not been an official news release but the SEC Filings discloses a delay in the marketing partnership of AFRESA, its ultra rapid-acting insulin product candidate.

The company issued an SEC filing this morning stating:

  • We had previously disclosed that we had set a goal of entering a marketing partnership for AFRESA, our ultra rapid-acting insulin product candidate, before the end of 2009, with an internal objective of the end of the third quarter. We made substantial progress toward a definitive agreement with a lead potential partner; however, as the discussions progressed, we came to believe that it would be more productive to complete a partnership after we have received a response from the United States Food and Drug Administration, or FDA, regarding our new drug application for AFRESA. We believe that we and our potential partners will be better able to address appropriate deal terms and structure once the label for AFRESA is clarified. Since we do not expect a response from the FDA before January 2010, we believe that we will not conclude a deal before the end of 2009. We continue to believe that AFRESA represents a significant commercial opportunity.

In the first ten minutes of trading alone, we have seen 1.5 million shares trade hands and the stock is down even worse than at the open.  Shares were down by 16% at $7.60 right after the open, but now shares are down a sharp 25% at $6.78 on about 1.6 million shares. Average volume here is 985,000 or so shares per day and the 52-week trading range is $2.00 to $12.30.

JON C. OGG
OCTOBER 6, 2009

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