The stock of MannKind Corp. jumped on Wednesday following news that the Food and Drug Administration would no longer require the company to adhere to a special plan to communicate the risks and benefits of its inhalable insulin Afrezza.
MannKind previously was required to publish communications materials – including fact sheets handed out at scientific presentations as well as a dedicated website – detailing the risks Afrezza posed to patients with lung diseases. The mandate was part of a Risk Evaluation and Mitigation Strategy, or REMS, a plan that the FDA requires some drug companies to create in the process of the drug approval process.
No longer having to adhere to a REMS frees up MannKind sales representatives to espouse the benefits of Afrezza to physicians rather than having to spend time warning them about the risks, noted Seeking Alpha blogger Spencer Osborne. Additionally, the development improves the perceived risk-benefit profile of the company’s proprietary Techosphere drug delivery platform, which MannKind can sell to other pharmaceutical firms.
Shares of MannKind (MKND) rose 7 cents, or 4 percent, on Wednesday to close at $1.80 on the Nasdaq.