Evoke Pharma soars on news of Gimoti approval

USA-based  Evoke Pharma (Nasdaq: EVOK) saw its shares rocket 74.5% to $4.10, following the announcement after the closing bell on Friday that the US Food and Drug Administration has approved the New Drug Application (NDA) for Gimoti (metoclopramide) nasal spray, the first and only nasally-administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

The approval follows a setback in April last year, when the agency issued a complete response letter (CRL) on Gimoti, citing the need for additional data related to clinical and product quality/device quality. Evoke currently expects to launch commercial sales of Gimoti in the fourth quarter of 2020 through its commercial partner Eversana Life Sciences Service.

“We are extremely pleased to have received FDA approval to commercially market Gimoti in the United States. This approval represents the first novel pharmaceutical treatment for gastroparesis in several decades. Many times, patients do not experience adequate relief of their gastroparesis symptoms from current treatments, representing a significant need for a new approach to therapy. We are excited to be able to offer health care providers and their patients a unique non-oral treatment option to relieve symptoms and help improve their quality of life,” said David Gonyer, president and chief executive of Evoke.