Evoke Pharma Inc. (NASDAQ:EVOK)
Evoke Pharma Inc. (NASDAQ:EVOK) traded lower after announcing positive top-line results from a comparative exposure pharmacokinetic (PK) study. Shares of the specialty pharmaceutical company fell 6.98% to end Monday’s trading session at $3.20 a share.
New Drug Application
The sell-off added fuel to a downtrend that has plagued the stock in recent trading sessions. Evoke Pharma Inc. (NASDAQ:EVOK) has struggled to close above the $4 a share mark on two attempts amidst concerns that an uptrend, which began in August, could be losing momentum. However, the stock has outperformed the overall industry and is up by more than 40% for the year.
The stock is currently rated as a “Strong Buy” by one analyst firm, a “Hold” by three firms, and a “Sell” by one firm, according to data compiled by Zack Investment research
The topline clinical results come from a trial that sought to demonstrate that the company’s proposed novel treatment for diabetic gastroparesis has similar systemic exposure to Reglan Tablets. Buoyed by the positive results, the company intends to submit a New Drug Application (NDA) with a selected dose of Gimoti to the U.S. Food and Drug Administration (FDA). Gimoti is Evoke Pharma Inc. (NASDAQ:EVOK) lead candidate drug for the treatment of symptoms associated with acute and recurrent diabetic gastroparesis. Last month, the company completed subject dosing as part of an ongoing pharmacokinetic study. Results are expected in the fourth quarter.
The company is preparing the NDA application in partnership with RHO, a well-established research organization that that has worked on other successful gastrointestinal NDA submissions
“In the first quarter of 2018, we will submit the NDA with these PK data, as well as safety and efficacy data from five prior Evoke clinical studies in healthy volunteers and patients with diabetic gastroparesis. We believe Gimoti has the potential to become the new standard of care for patients suffering from this debilitating disease,” said CEO David Gonyer.
Q2 Financial Results
Separately, Evoke Pharmaceuticals reported a net loss of (-$1.6) million for the second quarter, nearly half a net loss of (-$3) million reported last year. Net loss in the quarter was partially offset by $1.3 million associated with a change in the fair value of warrant liability.
Research and development expenses in the quarter came in at $2 million compared to $2.1 million reported in Q2, 2016. Evoke Pharma Inc. (NASDAQ:EVOK) had approximately $12.6 million in cash and cash equivalent as of June 30, 2017.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.