EVOKE PHARMA, INC. (NASDAQ:EVOK) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01  Entry into a Material Definitive Agreement.

On April 17, 2017, Evoke Pharma, Inc. (the “Company”) entered into an agreement to work in partnership with Spaulding Clinical Research for its planned comparative exposure pharmacokinetic (PK) trial for its lead product candidate, Gimoti™, a patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. The pivotal PK trial conducted in healthy volunteers is designed to establish bioequivalence with the listed drug, Reglan^®Tablets, and may serve as a basis for the 505(b)(2) new drug application (NDA) planned for submission to the Food and Drug Administration (FDA).

This PK trial follows recent communications with FDA regarding the final clinical development steps for the NDA submission.  The Company held a face-to-face pre-NDA meeting with FDA in December 2016 to propose and discuss this PK trial and recently confirmed the final protocol design during a Type A Meeting with FDA last month. The Company engaged Spaulding to execute this trial and is now in the latter planning stages to initiate the trial.

The foregoing description of the agreement does not purport to be complete and is qualified in its entirety by the agreement, a copy of which the Company intends to file with its Quarterly Report on Form 10-Q for the period ending June 30, 2017, requesting confidential treatment for certain portions.

About EVOKE PHARMA, INC. (NASDAQ:EVOK)

Evoke Pharma, Inc. is a specialty pharmaceutical company. The Company is focused primarily on the development of drugs to treat gastrointestinal (GI) disorders and diseases. The Company is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women. EVK-001 is a formulation of Metoclopramide drug, designed to provide systemic delivery of metoclopramide through intranasal administration. The Company has evaluated EVK-001 in a multicenter, randomized, double-blind, placebo-controlled parallel group, dose-ranging Phase IIb clinical trial. The Company has commenced a Phase III clinical trial of EVK-001 in female patients with symptoms associated with acute and recurrent diabetic gastroparesis. The Phase III clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety and population pharmacokinetics of EVK-001 in adult females.

EVOKE PHARMA, INC. (NASDAQ:EVOK) Recent Trading Information

EVOKE PHARMA, INC. (NASDAQ:EVOK) closed its last trading session 00.00 at 2.70 with 206,709 shares trading hands.