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The path to approval for MannKind's (Nasdaq: MNKD ) key drug, Afrezza, is starting to take shape.
Shares jumped as much as 33% this morning, after the company announced that the Food and Drug Administration has confirmed two clinical studies to evaluate the efficacy and safety of the inhaled insulin treatment. The drugmaker met with the FDA on Wednesday, and clearly the meeting was a success. MannKind COO Hakan Edstrom added that the company was also "encouraged to proceed promptly with the initiation of both clinical trials."
This announcement is critical to the company, since it's a step closer to finally getting a drug on the market. The company has been burning cash, as it has no revenue and its coffers have been dwindling. But even if Afrezza finds its way to the market, it will face a host of established competitors, like Eli Lilly’s (NYSE: LLY ) Humalog. Furthermore, Pfizer (NYSE: PFE ) once took a shot at an inhaled insulin drug, Exubera, but promptly abandoned it because of weak sales. If Afrezza scores the FDA's blessings, shareholders can only hope that it won't suffer the same fate. MannKind has a lot more riding on Afrezza than Pfizer did with Exubera.
This stock is still a little too much of a long shot for my tastes, although the odds did get a little better with this confirmation. I'm no stranger to risk, but in this case I still think there's a little too much uncertainty. MannKind may end up hitting the jackpot with Afrezza, but I'm not planning on attending the celebration.