MannKind Corp. (MNKD) said the U.S. Food and Drug Administration's review of its new drug application for its inhaled-insulin product for diabetics will require four additional weeks.
The biopharmaceutical company, which has no products on the market currently, had been expecting FDA approval of Afrezza by Wednesday.
MannKind has been hoping to succeed where larger drug makers have failed. In the mid-2000s, several companies were seeking to bring an inhaled formulation of insulin to market as an alternative to injections.
The FDA initially had sought more information from MannKind in March about how the available data support the clinical utility of Afrezza in the marketplace, though the company at the time still planned a 2011 launch of the product. The FDA accepted its resubmission in July.
The company also was dealt a setback in November when a former senior manager accused the drug developer of unlawful practices in its conduct of clinical trials, an accusation the company denies.
Shares closed Monday at $7.97 and were inactive premarket. The stock is still down 9% this year, though it has recovered some of its losses since the FDA's action in March.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481; Tess.Stynes@dowjones.com