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No April Fool's Joke: MannKind's Critical Vote

Shares of MannKind (NASDAQ: MNKD  ) took more than a 5% haircut on Friday as briefing documents came out for its upcoming FDA advisory committee meeting on Tuesday. The documents are a mixed bag, which should make for a very interesting debate in Tuesday's meeting. The drug, an inhaled form of insulin called Afrezza, had efficacy that looked good for type 2 diabetes, but wasn't as convincing on type 1. There are also potential safety concerns, including an imbalance of lung cancer cases in the drug's cohort which could be associated with inhaled insulin as a drug class. A similar small imbalance, dogged a predecessor product, Pfizer's (NYSE: PFE  ) Exhubera.

There is a great deal of investor optimism around the sales potential of Afrezza, as an alternative to needles. Investors see Novo Nordisk's (NYSE: NVO  ) Novalog and Eli Lilly's (NYSE: LLY  ) Humalog's roughly $1.5 billion each in U.S. sales last year and think it can capture a significant portion, possibly as much as a quarter of that market. However, MannKind's high valuation and significant downside risk if Afrezza is rejected, makes this a stock even serious biotech investors with a Mount Everest-high risk tolerance should probably watch from sidelines. 

In this video, Motley Fool health-care analyst David Williamson looks at MannKind today, ahead of the advisory committee's meeting. The vote could greatly affect the outcome of an FDA decision. David discusses the potential for the drug on the market, and how MannKind would be affected by an FDA rejection.

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  • Report this Comment On March 31, 2014, at 3:23 PM, Imcynical wrote:

    "I am am curious to find out from the FDA how a patient is expected to inhale insulin through a stuffy noise. "

    Not sure about through their "noise", but as most inhalers work through the mouth, I'm guessing that is it!

  • Report this Comment On March 31, 2014, at 7:55 PM, dealmastergee wrote:


    You don't inhaled it through your nose ...

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David Williamson

The Motley Fool's Healthcare Analyst, I specialize in Pharma, Biotech, and how the ACA (Obamacare) is changing the business of healthcare in America. Follow me on Twitter for breaking stock news, policy thoughts, and misc musings...

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9/1/2015 3:59 PM
MNKD $3.71 Down -0.08 +0.00%
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