Publish date:

Cardiome Slips on FDA Delay

The regulatory agency requests a panel and more clinical data for arrhythmia drug Vernakalant.

Shares of

Cardiome Pharma


slid early Thursday as investors weighed a regulatory delay for the life sciences company's arrhythmia drug Vernakalant, which involved a request for a panel and more clinical data.

TheStreet Recommends

Cardiome and its partner Astellas said Monday that the Food and Drug Administration requested a panel review -- set for Dec. 11-12 -- to be conducted by the Cardiovascular and Renal Drugs Advisory Committee, delaying by three months its decision on the drug.

In conjunction with the request, the agency asked for additional information, including final safety and efficacy data from the ACT 2 clinical trial, which was ongoing at the time of original submission of the new-drug application.

The new decision date for the drug is Jan. 19, pushed back from the prior Oct. 18 target date.

Shares fell 46 cents, or 5%, to $8.86 in recent trading Thursday.