MannKind Corp. (NASDAQ: MNKD) is a stock that has been on a wild ride for many years. The company’s inhalable insulin has been held up from being approved for years as well. That seems to be coming to a head now, but investors have to understand just how big this game is. It can be a homerun, but it can also be a crusher if the FDA goes against it.
After a huge gain on Thursday, shares tanked on Friday. MannKind announced that AFREZZA’s review date is tentatively scheduled for April 1, 2014. If you have followed this story for as long as we have, you might find the same irony that the date is set for April Fool’s Day. The company’s press release said that the target date for FDA’s AFREZZA review is actually April 15, 2014.
We would point out that the date and details are subject to FDA conformation via a Federal register notice. MannKind had resubmitted its new drug application back on October 13, 2013 to assist in helping adults with Type-1 or Type-2 diabetes.
Be advised that MannKind will be making a presentation to investors at the JPMorgan 2014 Healthcare Conference on Wednesday, January 15, 2014. The company has maintained for years that AFREZZA is approvable. MannKind has also had close to $900 million in operating losses from expenses and R&D in the last five years or so, with total losses being far higher than that since its inception.
Options trading was elevated on Thursday, and the same thing is true for Friday. This implied volatility is enough to make or break careers.
Based upon the new data, options traders are now moving their bets out to May 2014 because there are not yet active April contracts. A volatility bet at the $6 strike prices for both the put and call combined would be the equivalent of close to $4.25 per share. For that to pay off, investors would have to see the stock fall to under $1.75 or rise above $10.25 by May 17. We won’t bother telling you expensive the options are if you go out later in 2014 or into 2015 (or 2016).
Shares were down 13% at $6.16 on almost 18 million shares with about 90 minutes of trading left on Friday. Thursday’s gain was over 18% to a close of $7.08 on over 24 million shares.