Valencia biotech MannKind Corp. said Monday the U.S. Food and Drug Administration accepted and is now reviewing its application for the inhaled insulin drug Afresa.
Having the regulator accept the application on the company? first try is considered a significant milestone. Competitor Pfizer Inc. pulled a similar drug off the market for safety reasons, and other companies later dropped their own development programs.
The company is seeking approval for Afresa's use in Type 1 or Type 2 diabetics to control high blood sugar levels, which tend to spike after eating. MannKind contends its proprietary Technosphere technology enables fast-acting insulin to be absorbed more easily and safely, and hopes to use the technology with other drugs.
MannKind? shares have more than doubled in recent weeks, and they hit a 52-week high of $7.50 on May 11. The company said during a conference call that it was in advance-stage talks with "major" pharmaceutical companies to help bring the drug to market if approved, which could come later his year. Shares had sunk below $2 last year on concerns about the viability of the sector.
Shares closed up nearly 8 percent to $6.39 on the Nasdaq.
For reprint and licensing requests for this article, CLICK HERE.
Stories You May Also Be Interested In
- Inhaled-Insulin Developer Now Waiting to Exhale
- MannKind Files for Inhaled Insulin Approval
- FDA Delays Decision on MannKind Drug
- MannKind Says Study Upholds Product's Safety
- MannKind Shares Jump on Partnership Talks
- MannKind to Buy Pfizer Insulin Factory
- MannKind Narrows Loss in Quarter
- MannKind Narrows Loss