8-K 1 pdufadateextensionform8-k.htm 8-K Document


 
 
 
 

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): June 6, 2019 (June 5, 2019)
_______________________________

XERIS PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

______________________________

Delaware
001-38536
20-3352427
(State or other jurisdiction of
incorporation)
(Commission
File Number)
(I.R.S. Employer
Identification No.)
 
 
 
 
 
 
 
180 N. LaSalle Street, Suite 1600
Chicago, Illinois 60601
 
 
(Address of principal executive offices, including zip code)
 
 
(844) 445-5704
(Registrant's telephone number, including area code)
 
Not Applicable

(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:
 
 
¨

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))
 
 
 
 
 
 
 
 
 
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.0001 per share
XERS
The Nasdaq Global Select Market
 
 
 
 
 
 
 
 
 
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 þ
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 June 6, 2019, Xeris Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (FDA) extended from June 10, 2019 until September 10, 2019 the initial Prescription Drug User Fee Act (PDUFA) action goal date for the Company’s new drug application (NDA) seeking marketing approval of GvokeTM (ready-to-use glucagon injection). The Company received a notification letter from the FDA on June 5, 2019, which states that the Company’s recent submission in response to an information request from the FDA constitutes a major amendment to the NDA, and the FDA therefore is extending the goal date by three months to provide time for a full review of the submission.
A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01    Financial Statements and Exhibits

(d) Exhibits:










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.

Date: June 6, 2019
 
Xeris Pharmaceuticals, Inc.
 
 
 
 
 
 
 
By:
/s/ Barry M. Deutsch
 
 
 
 
Name: Barry M. Deutsch
 
 
 
 
Title: Chief Financial Officer