Evoke Pharma soars on HF validation study exemption on Gimoti from FDA

16 February 2017

USA-based Evoke Pharma (Nasdaq: EVOK) said yesterday that it has received a letter from the Food and Drug Administration exempting its late stage product, Gimoti from a Human Factors (HF) validation study requirement prior to submission of a New Drug Application (NDA).

Gimoti is Evoke's patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.

Shares of Evoke were trading up about 65% at $4.30 Wednesday morning, and were still up 30.3% at $3.40 by close of trading, 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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