Evoke Pharma Inc NASDAQ false 0001403708 0001403708 2022-04-26 2022-04-26












Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 26, 2022




(Exact Name of Registrant as Specified in its Charter)




Delaware   001-36075   20-8447886

(State or Other Jurisdiction

of Incorporation)



File Number)


(IRS Employer

Identification No.)


420 Stevens Avenue, Suite 370

Solana Beach, California

(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (858) 345-1494

(Former Name or Former Address, if Changed Since Last Report.)



Securities registered pursuant to Section 12(b) of the Exchange Act


Title of each class





Name of each exchange

on which registered

Common Stock,

par value $0.0001 per share

   EVOK    The Nasdaq Capital Market

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐




Item 8.01

Other Events.    

On April 26, 2022, Evoke Pharma, Inc. (“Evoke” or the “Company”) announced that it has been granted new drug product exclusivity by the U.S. Food and Drug Administration (“FDA”) for GIMOTI (metoclopramide) nasal spray. Evoke now has exclusive marketing rights over a period of three (3) years from the original date of approval under the Hatch-Waxman Act to protect the product from generic drug competition. Enacted by Congress in 1984, the Hatch-Waxman Amendments include provisions that involve patents and exclusivities related to new drug applications.

In addition to the market exclusivity, Evoke maintains a robust patent estate, with currently two Orange book-listed patents entitled “Nasal Formulations of Metoclopramide,” U.S. Patent No. 11,020,361, and U.S. Patent No. 8,334,281, that expire in 2029 and 2030, respectively. Evoke has also been granted gender-specific patents in the E.U., Japan, and Mexico with coverage until 2032. Furthermore, the Company has other pending patent applications with individual expiration dates of 2032, 2037, and 2038, if approved.

Safe Harbor Statement

Evoke 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 expected benefits from market exclusivity GIMOTI and expectations on the scope of intellectual property protection; and the ability of Evoke to capitalize on the gastroparesis market opportunity. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this report due to the risks and uncertainties inherent in Evoke’s business, including, without limitation: Evoke’s ability to maintain intellectual property protection for GIMOTI; and other risks and uncertainties detailed in Evoke’s prior periodic 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 Evoke 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.


Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


April 26, 2022


/s/ Matthew J. D’Onofrio

            Matthew J. D’Onofrio

Executive Vice President,

Chief Business Officer and Secretary