UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

 

CURRENT REPORT

 

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of report (Date of earliest event reported): November 25, 2019

 

 

ADAMIS PHARMACEUTICALS CORPORATION

(Exact Name of Registrant as Specified in Charter)

 

Delaware   0-26372   82-0429727

(State or other jurisdiction

of incorporation)

  (Commission File Number)  

(IRS Employer

Identification No.)

         

11682 El Camino Real, Suite 300

San Diego, CA

  92130
(Address of Principal Executive Offices)   (Zip Code)
             

 

Registrant’s telephone number, including area code: (858) 997-2400

 

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

 

 

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. ☐

 

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

 

Title of each class   Trading Symbol(s)   Name of each exchange on
which registered
Common Stock   ADMP   NASDAQ Capital Market

 

 
 

Item 8.01 Other Events

 

On November 25, 2019, Adamis Pharmaceuticals Corporation (“Adamis” or the “Company”) issued a press release announcing that after the close of U.S. markets on November 22, 2019, it received a Complete Response Letter (“CRL”) from the U.S. Food & Drug Administration (“FDA”) regarding the Company’s New Drug Application (“NDA”) for its ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose. A CRL is issued by the FDA's Center for Drug Evaluation and Research when it has completed its review of a file and questions remain that preclude the approval of the NDA in its current form.  

The CRL stated that the FDA determined that it cannot approve the Company’s NDA in its present form.

The Company is reviewing the CRL and plans to request a meeting with the FDA to discuss the CRL and the Company’s response to the CRL. A copy of the Company’s press release is attached hereto as Exhibit 99.1 is incorporated into this item by reference.

 

Item 9.01 Financial Statements and Exhibits

 

 

Exhibit No. Description
99.1 Press Release dated November 25, 2019.

 
 

SIGNATURES

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.

  ADAMIS PHARMACEUTICALS CORPORATION
     
     
     
Dated:  November 25, 2019 By: /s/ Robert O. Hopkins
  Name: Robert O. Hopkins
  Title: Chief Financial Officer