Evoke Pharma Inc (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal diseases, today announced that it has completed a pre‑New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, Gimoti™, its patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. The focus of this pre-NDA meeting with the FDA was the content of the regulatory, chemistry, manufacturing, and control (CMC), and non-clinical sections of the Company’s planned 505(b)(2) NDA for Gimoti.
Prior to the pre-NDA meeting, Evoke submitted an information package describing the proposed content and format of the regulatory, CMC, and non-clinical sections of the Gimoti NDA. The subsequent face-to-face pre-NDA meeting afforded Evoke the opportunity to gain further understanding of the FDA’s expectations regarding these key sections of the NDA.
Based on the FDA’s response to the information package and the pre-NDA meeting discussion, Evoke believes it now has the information needed to complete these sections of the NDA in a manner that will be acceptable for the FDA’s review of the complete package.
“We are pleased to have begun discussions with the Agency regarding our proposed NDA submission for Gimoti utilizing the 505(b)(2) pathway. We had a very productive meeting and this portion of our data package was well-received,” Dave Gonyer, R.Ph., President and CEO, stated. “Additionally, it was agreed that Evoke will request to meet with the FDA again in the near future to discuss the clinical data that will comprise the remaining sections of the NDA.” (Original Source)
Shares of Evoke Pharma are up nearly 14% in early trading Wednesday. EVOK has a 1-year high of $11.11 and a 1-year low of $1.52. The stock’s 50-day moving average is $2.20 and its 200-day moving average is $4.61.
On the ratings front, EVOK has been the subject of a number of recent research reports. In a report issued on August 16, H.C. Wainwright analyst Ram Selvaraju maintained a Hold rating on EVOK, with a price target of $2.50, which represents a potential upside of 37% from where the stock is currently trading. Separately, on the same day, Brean Capital’s Difei Yang maintained a Hold rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ram Selvaraju and Difei Yang have a total average return of 0.2% and -10.1% respectively. Selvaraju has a success rate of 43% and is ranked #2346 out of 4147 analysts, while Yang has a success rate of 33% and is ranked #4008.
Overall, 4 research analysts have assigned a Hold rating and one has given a a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $3.00 which is 64.8% above where the stock closed yesterday.
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.