Key FDA Exemption Clears the Way for Shares of Evoke Pharma Inc (NASDAQ:EVOK)


Evoke Pharma Inc (NASDAQ:EVOK) blasted off into the stratosphere today on the heels of a vital announcement pertaining to a key FDA exemption. Whenever a press release comes down the pike concerning FDA actions, hysteria generally ensues, and we’re seeing quite a bit of that in early trading today.

Shares of EVOK stock surged convincingly into the $4.00-range with traders clambering to get a piece of the action. This is after gapping up tremendously from a 2.61 close yesterday. A pullback off of initial highs is to be expected, but the faster track one of the company’s treatments just received has officially made EVOK an item of interest for us in the longer-term.

The key development that has occurred with Evoke Pharma Inc (NASDAQ:EVOK) and is generating the buzz is the FDA’s move to exempt the company’s late stage product, Gimoti™ from further study prior to its planned submission of a New Drug Application (NDA).



About Evoke Pharma

Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing Gimoti, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Diabetic gastroparesis is a GI disorder afflicting millions of sufferers worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. Metoclopramide is the only product currently approved in the United States to treat gastroparesis, and is currently available only in oral and intravenous forms. Gimoti is a novel formulation of this drug, designed to provide systemic delivery of metoclopramide through nasal administration. Visit for more information.


FDA Exempts Gimoti™ From Human Factors Validation Study

Typically, under new regulations, before submitting an NDA to the FDA on products that require both a device and a drug to implement, new treatments have to undergo a battery of trials, including Human Factors Validation studies.

To comply with this new Guidance, Evoke evaluated the need for an HF Validation study and submitted an HF assessment report to FDA for Gimoti using a Failure Mode and Effects Analysis risk analysis taking into account the intended uses, users, use environments, product-user interface, and associated medical factors. In their written response, FDA stated Evoke had adequately considered the risks associated with the proposed Gimoti nasal spray and determined that an HF Validation study is not needed at this time.

Dave Gonyer, CEO of EVOK offered his comments on the new development: “We are very pleased with the continued FDA communication and their agreement that an HF Validation study is not needed. This is another step closer to a potential NDA submission which our entire team remains focused to deliver this year. Given FDA agreement at a recent pre-NDA meeting to conduct a comparative exposure trial in healthy subjects, we are finalizing procedures to initiate that trial as soon as possible.  We intend to pursue an NDA submission by the end of the year and plan to update our investors in the near term with more specific timelines on these efforts.” (Source: Globe Newswire)



We’re going to be sure to continue tracking the story on EVOK as it continues along the path toward an NDA filing for Gimoti™. We’ll be very interested to see how much of the ground it rapidly gained on the chart this morning can be maintained throughout the remainder of the day, and into future sessions. Stay locked to the for updates on EVOK, and we’ll deliver important developments as they unfold. In the meantime, if you’ve yet to sign up for our 100% free newsletter, do so now! Just enter your active email address into the box below and get subscribed!