Shares of MannKind Corp. ( MNKD ) hit a 52-week high of $11.11 during the trading session on Jun 5. MannKind subsequently closed the trading session at $10.04.
With more than 93% of year-to-date return, this biopharma stock looks attractive, as the U.S. Food and Drug Administration's (FDA) target date of Jul 15 on its lead candidate, Afrezza, draws nearer. The average volume of shares traded over the last three months stands at approximately 10,550 K.
This Zacks Rank #3 (Hold) stock has been flying high ever since it received a positive opinion from the FDA's Endocrinologic and Metabolic Drugs Advisory Committee on Apr 1 regarding the approval of Afrezza to improve glycemic control in adults with type I and type II diabetes. Shares have soared almost 150% since then.
While the panel unanimously recommended (14-0) the approval of Afrezza in the U.S to improve glycemic control in adults with type II diabetes, it voted 13-1 in favour of Afrezza to improve glycemic control in adults with type I diabetes. MannKind is finally hoping to see Afrezza in the market after being through a number of regulatory setbacks. The FDA had previously issued two complete response letters for the diabetes candidate.
However, the FDA had stated in its briefing document prior to the panel vote that although the candidate demonstrated statistically superior HbA1c reduction compared to placebo, it failed to demonstrate a higher HbA1c reduction compared to Novo Nordisk 's ( NVO ) NovoLog in type I diabetes patients. Moreover, the FDA was concerned with the observed safety findings on Afrezza including pulmonary safety, lung cancer risk and disease specific safety issues.
We expect investor focus to remain on the approval of Afrezza. Marketing approval of Afrezza will come as a huge boost for the company.
Other Stocks to Consider
Some better-ranked stocks in the same sector include Gilead Sciences Inc. ( GILD ) and Alexion Pharmaceuticals, Inc. ( ALXN ). While Gilead holds a Zacks Rank #1 (Strong Buy), Alexion carries a Zacks Rank #2 (Buy).
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.