Evoke Pharma plan for accelerated review of NDA for lead product candidate Gimoti now more so; shares ahead 57%
Feb. 15, 2017 11:19 AM ET|About: Evoke Pharma, Inc. (EVOK)|By: Douglas W. House, SA News Editor
Nano cap Evoke Pharma (EVOK +56.7%) jumps on a healthy 14x surge in volume in response to its announcement that the FDA will not require it to conduct a human factors study to support an NDA filing for lead product candidate Gimoti, its nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.
The company intends to submit its U.S. marketing application by year end under the accelerated 505(b)(2) pathway which allows the inclusion of data from studies performed by others.
Previously: Evoke Pharma mines data from failed late-stage study of Gimoti in diabetic gastroparesis; valid treatment effect in subset of patients; shares up 47% (Jan. 4)
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