Evoke Pharma Inc (NASDAQ:EVOK) investors have a smile on their faces Wednesday morning, after the drug maker announced that it has received a letter from FDA exempting its late stage product, Gimoti™ from a Human Factors (HF) Validation study requirement prior to submission of a New Drug Application (NDA).
In February 2016, FDA published new guidance entitled “Applying Human Factors and Usability Engineering to Medical Devices”, which requires 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.
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. The favorable FDA response helps reduce potential risks and saves additional resources in the development process including NDA preparation.
“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,” commented Dave Gonyer R.Ph., President and CEO. Mr. Gonyer continued, “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.”
Evoke Pharma shares are currently trading at $3.79, up $1.18 or 45%. EVOK has a 1-year high of $11.11 and a 1-year low of $1.35. The stock’s 50-day moving average is $2.47 and its 200-day moving average is $2.07.
On the ratings front, Evoke has been the subject of a number of recent research reports. In a report issued on January 5, FBR analyst Vernon Bernardino maintained a Buy rating on EVOK, with a price target of $9, which represents a potential upside of 245% from where the stock is currently trading. On December 23, H.C. Wainwright’s Ram Selvaraju reiterated a Hold rating on the stock and has a price target of $2.50.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vernon Bernardino and Ram Selvaraju have a yearly average loss of 15.4% and 2.7% respectively. Bernardino has a success rate of 27% and is ranked #4386 out of 4453 analysts, while Selvaraju has a success rate of 39% and is ranked #4120.
Evoke Pharma, Inc. is a pharmaceutical company, which engages in the development of drugs for the treatment of gastrointestinal disorders and diseases. It develops EVK-001 for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women.