Evoke Pharma, Inc. (NASDAQ: EVOK) announced on Friday via SEC filing that the U.S. Food and Drug Administration has approved the New Drug Application 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 Company currently expects to launch commercial sales of GIMOTI in the Q4 of 2020 through its commercial partner Eversana Life Sciences Services.
The FDA approval of GIMOTI allows Evoke to access its existing $5 million line of credit from EVERSANA, to support manufacturing and other aspects of GIMOTI’s commercialization.
As of May 31, 2020, the Company’s cash and cash equivalents were approximately $4.7 million. Evoke believes, based on its current operating plan, that its cash and cash equivalents, together with the EVERSANA line of credit, will support the company’s operations into 2021, without consideration of potential GIMOTI revenue.
Evoke Pharma Inc (NASDAQ: EVOK) stock price gained 2.62% on Friday but the FDA approval is announced after the closing bell.