EVOKE PHARMA, INC. (NASDAQ:EVOK) Files An 8-K Other Events
Item 8.01Other Events.
On January 21, 2020, Evoke Pharma, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (“FDA”) has accepted the Company’s resubmission of its 505(b)(2) New Drug Application (“NDA”) for Gimoti™, the Company’s nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.
A six-month period of review from the FDA’s date of receipt has been assigned for the resubmitted NDA and the application has been assigned a new Prescription Drug User Fee Act (“PDUFA”) target goal date of June 19, 2020.
Safe Harbor Statement
The Company cautions you that statements included in this report that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the Company’s current beliefs and expectations. These forward-looking statements include statements regarding: the timing and results of any decision regarding the NDA from the FDA, including whether FDA will act by the PDUFA target goal date; the Company’s belief that Gimoti, if approved, can fill an unmet medical need for the management of diabetic gastroparesis and improve the quality of life for patients suffering from the disease; and the Company’s plans to focus on commercial readiness. The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Company’s business, including, without limitation: the potential for the FDA to delay the PDUFA target goal date due to the FDA’s internal resource constraints or other reasons; the Company may be unable to timely and successfully address the deficiencies raised in the Complete Response Letter (“CRL”) regarding Gimoti, including as a result of adverse findings from a root cause analysis or data from the newly manufactured product batches not fully addressing issues raised by the FDA in the CRL and type A meeting; FDA may not agree with the Company’s conclusion of the results from the manufacturing testing or the root cause analysis, or may require the Company to conduct additional studies; further analysis of the manufacturing data; the FDA may later determine to hold an advisory committee meeting and risks associated therewith; the inherent risks of clinical development and regulatory approval of Gimoti; the Company’s dependence on third parties for the manufacture of Gimoti and analysis of the manufacturing data; the Company is entirely dependent on the success of Gimoti; the Company will require substantial additional funding to continue its operations into the second quarter of 2020, and may be unable to raise capital or obtain funds when needed, including to fund ongoing operations; the Company could face significant additional costs due to litigation or other events; the Company’s ability to maintain the continued listing of its common stock on the Nasdaq Capital Market; and other risks detailed in the Company’s prior reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward‑looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
About EVOKE PHARMA, INC. (NASDAQ:EVOK)
Evoke Pharma, Inc. is a specialty pharmaceutical company. The Company is focused primarily on the development of drugs to treat gastrointestinal (GI) disorders and diseases. The Company is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women. EVK-001 is a formulation of Metoclopramide drug, designed to provide systemic delivery of metoclopramide through intranasal administration. The Company has evaluated EVK-001 in a multicenter, randomized, double-blind, placebo-controlled parallel group, dose-ranging Phase IIb clinical trial. The Company has commenced a Phase III clinical trial of EVK-001 in female patients with symptoms associated with acute and recurrent diabetic gastroparesis. The Phase III clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety and population pharmacokinetics of EVK-001 in adult females.
