MannKind Shares See #PreMarket Spike Following FDA Approval

After the market close on June 27, MannKind MNKD announced that it has received approval from the FDA for AFREZZA, an inhalation powder intended to improve glycemic control in adults with diabetes mellitus.

At last check, shares of MannKind hit a high of $12.50 in Monday's pre-market session after closing at $10 on Friday; shares have since pulled back to around $11.18.

"Approval of AFREZZA is an important milestone for MannKind, as today's FDA action validates the years of clinical research and commitment that powered the development of this unique therapy," said MannKind CEO Alfred Mann.

"We have seen in clinical studies that the combination of rapid action, injection-free delivery and ease of use makes AFREZZA a welcome alternative for many patients who require insulin," said Janet McGill, M.D., Professor of Medicine at Washington University School of Medicine.

Also included in the press release were the drug limitations of use, as well as a list of precautions and warnings