Evoke Pharma Inc (NASDAQ: EVOK)
Evoke Pharma is having an incredible morning in the market this morning, and for good reason. The FDA has confirmed the acceptability of a key trial, causing investor excitement and pushing the stock upward. Of course, our partners at Trade Ideas were the first to alert us of the upward movement. At the moment (8:49), EVOK is trading at $3.67 per share after a gain of $0.58 per share or 18.77% thus far today.
EVOK Gains On FDA News
As mentioned above, Evoke Pharma is having a strong start to the day in the market today after announcing news surrounding the FDA. The company announced that it has recently completed a Type A meeting with the United States Food and Drug Administration that was centered around finalizing the design of the pivotal comparative exposure pharmacokinetic trial. As a result of the meeting, the two parties have reached an agreement with regard to aspects of the chemistry, manufacturing & controls section of the NDA for Gimoti(TM). In a statement, Dave Gonyer, R.Ph., President and CEO at EVOK had the following to offer…
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“We are pleased to have FDA’s input on the protocol for our comparative exposure PK trial, which, along with collecting CMC data associated with the trial, we believe are the last key items to be completed prior to submission of the NDA for Gimoti… In our communications and discussions with FDA, the Agency provided advice on the proposed design of the study, which helps clear the path to move ahead with our timeline as scheduled. We remain confident in our ability to continue to execute on the milestones that we have outlined to bring Gimoti to commercialization.”
What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on EVOK. In particular, we’ll be watching for any updates surrounding Gimoti. With the FDA’s clearance on the coming clinical trial, things are looking pretty good at the moment. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
What Do You Think?
Where do you think EVOK is headed? Join the discussion in the comments below!
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