Evoke Pharma Inc. (NASDAQ: EVOK) made a handy gain in Wednesday’s session following a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA). Coming out of this meeting, the company believes that it now has the data it needs to complete the NDA and move the process forward for its lead product candidate, Gimoti, also known as EVK-001.
This is welcomed news after the stock cratered (80%) in mid-July after its late-stage clinical trial did not achieve its primary endpoints. Management called these top-line results “unexpected and an anomaly,” considering that the drug has been approved for this indication for over 35 years. Seemingly all that has changed is the delivery system.
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.
For some background on Gimoti: it is a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Currently, metoclopramide is the only product currently approved in the United States to treat gastroparesis, and it is currently available only in oral and intravenous forms. The nasal spray by Evoke offers a less invasive option.
Dave Gonyer, R.Ph., president and CEO of Evoke Pharma, commented on the meeting:
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. 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.
Shares of Evoke were trading up 19% at $2.17 on Wednesday, with a consensus analyst price target of $9.61 and a 52-week trading range of $1.52 to $11.11.