By Ben Glickman


Shares of Supernus Pharmaceuticals dropped Monday after regulators determined the company's new drug application was not ready for approval.

The stock was down 6.9% to $31.23 in afternoon trading. Shares are still up about 8% since the start of the year.

The Rockville, Md.-based biopharmaceutical company said that it had received a complete response letter from the U.S. Food and Drug Administration about its application for a device to help treat "off" episodes in Parkinson's disease.

The FDA said in its letter that two areas require additional review: the company's product quality and the master file for the infusion device.

Supernus said it recently submitted additional product quality data which has not yet been reviewed. The company said it would discuss the steps for resubmitting its new drug application with the device manufacturer.

Off periods can occur in people with Parkinson's disease when there is a spike in symptoms in between taking doses of treatment medications. The company's device specifically is meant to continuously treat motor fluctuations associated with these episodes.

Supernus said there were no clinical safety or efficacy issues identified as a requirement for approval.


Write to Ben Glickman at ben.glickman@wsj.com

(END) Dow Jones Newswires

04-08-24 1404ET