Shares of MannKind Corp. (MNKD) jumped 12 percent to $6.95 in Tuesday trading, the most intraday since June 24, after the co. founded by billionaire inventor Alfred Mann said the U.S. Food and Drug Administration [FDA] accepted the resubmission of the co.’s inhaled insulin product Affreza, classifying it as a class 2 response, which means the treatment will be reviewed within six months.
The Valencia, Calif., drug developer, which filed for FDA marketing approval in March 2009, said it expects a decision by Dec. 29.
“We have worked diligently since March to prepare our resubmission and we are confident that we have addressed the requests that were outlined by the FDA,” said Alfred Mann, MannKind Chairman and CEO. “We will continue to work closely with the FDA during this final stage of the review process. We firmly believe AFREZZA has the potential to address a poorly-met need in diabetes therapy. Our primary goal is to make this novel therapeutic option available to patients as soon as possible.”
MNKD shares were up 10.14 percent at $6.84 in late-morning trade Tuesday on Nasdaq.