ElectroCore Inc. said the U.S Food and Drug Administration has asked for additional information regarding the 510(k) submission for expanded approval of its handheld device gammaCore.
The Basking Ridge, N.J.-based company's stock was down 23.5% to $2.57 at market close Sept. 25.
The U.S. regulator has granted electroCore 180 days to comply with the request. The company expects to meet with the FDA in the fourth quarter of 2019 to discuss the request.
ElectroCore's 510(k) submission was based on results from the Premium 1 study. Chief Medical Officer Tony Fiorino said patients will continue to be enrolled in the Premium 2 study to examine the utility of the device in migraine.
GammaCore is already approved by the FDA for the treatment of pain associated with episodic cluster headache, migraine headache and as an additional treatment for the prevention of cluster headache.
