Evoke Pharma (EVOK) Misses Q3 EPS by 3c

November 9, 2016 4:16 PM EST
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Evoke Pharma (NASDAQ: EVOK) reported Q3 EPS of ($0.29), $0.03 worse than the analyst estimate of ($0.26).

Dave Gonyer, R.Ph., President and CEO, stated, “The third quarter was a very active time for Evoke. After receiving results from our Phase 3 clinical trial of Gimoti™ for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women, we began extensive data analysis to better understand the outcome. We also completed a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) related to various regulatory, chemistry, manufacturing, and control (CMC), and non-clinical requirements in connection with the Company’s potential Gimoti NDA submission. Based on the review, discussion, and minutes received, it was determined that the available data would be sufficient for submission of that portion of an NDA utilizing the 505(b)(2) pathway, with acceptance of the final NDA subject to their review of the complete package. We consider this non-clinical pre-NDA meeting a positive discussion based on these areas of development which will serve as a precursor to a future meeting to discuss the clinical portion of the NDA submission.”

Mr. Gonyer continued, “While our Phase 3 trial did not meet its primary endpoint, there was a wealth of affirmative information gained from this study and our Phase 2b trial, as well as data from over 35 years of patients using the oral and IV formulations of metoclopramide for the relief of symptoms associated with gastroparesis, particularly nausea and vomiting, all of which we believe will be important for our next meeting with the FDA. As we continue to explore the options for Gimoti, we have a strong balance sheet to support our efforts following two financings during the quarter. We look forward to our continued discussions with the FDA and are hopeful about the future for Gimoti and its potential to provide women suffering from diabetic gastroparesis with a needed non-oral therapeutic option.”

For earnings history and earnings-related data on Evoke Pharma (EVOK) click here.

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