Shares of Evoke Pharma Inc. soared 38% in premarket trade, after the Food and Drug Administration's positive assessment of the company's gastrointestinal disease treatment, Gimoti. The company said the FDA exempted the late-stage product from a Human Factors Validation study that is required prior to the submission of a new drug application. The FDA determined that Evoke had adequately considered the risks associated with the proposed Gimoti nasal spray, and therefore HF Validation as not needed at this time. Evoke said the FDA's determination helps reduce potential risks and saves additional resources for NDA preparation. "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," said Chief Executive Dave Gonyer. The stock had run up 60% over the past three months through Tuesday, but was still down 7.5% over the past 12 months, while the S&P 500 has climbed 25% over the past year.
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