Gastroparesis, also called delayed gastric emptying, is a disorder that slows or stops the movement of food from the stomach to the small intestine.
After the closing-bell Thursday, Evoke Pharma Inc. (Nasdaq:EVOK) reported positive guidance from a recent second pre-NDA (New Drug Application) meeting to discuss clinical data for inclusion in a 505(b)(2) NDA for Gimoti(TM) with the US Food and Drug Administration (FDA).
Evoke's Gimoti is a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus.
With the FDA's guidance, Evoke said that it intends to complete an additional pharmacokinetic trial and file an NDA, without the need for additional efficacy studies.
Shares of the specialty pharmaceutical company soared more than more than 45% following the announcement.
Evoke Pharma is focused primarily on the development of drugs to treat GI disorders and diseases.
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