Evoke Pharma Inc. (NASDAQ: EVOK) saw its shares make a huge gain on Wednesday after the company issued an update that it received from the U.S. Food and Drug Administration (FDA). According to the agency, Evoke’s Gimoti is exempt from a human factors (HF) validation study requirement prior to submission of its New Drug Application (NDA).

Back in February 2016, the FDA issued new guidance, which required drug products classified as a drug/device combination, such as Gimoti, undergo evaluation that may require an HF validation study as described in FDA’s guidance.

In an effort 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.

In response, the FDA stated that Evoke had adequately considered the risks associated with the proposed Gimoti nasal spray and determined that the HF validation study was not needed.

Ultimately, this FDA response helps to reduce potential risks and saves additional resources in the development process, including NDA preparation.

Dave Gonyer R.Ph., president and CEO of Evoke, commented:

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.

Shares of Evoke were trading up about 65% at $4.30 Wednesday morning, with a consensus analyst price target of $5.64 and a 52-week trading range of $1.35 to $11.11.

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