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 25, 2018

 

 

COHERUS BIOSCIENCES, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware

(State or other jurisdiction
of incorporation)

 

001-36721

(Commission
File Number)

 

27-3615821

(IRS Employer
Identification Number)

333 Twin Dolphin Drive, Suite 600

Redwood City, CA 94065

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (650) 649-3530

 

 

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))

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 June 25, 2018 the Committee for Medicinal Products for Human Use (“CHMP”) issued a draft agenda ahead of their June 25 to 28, 2018 meeting, indicating further interactions with Coherus BioSciences, Inc. (“Company”) regarding the outstanding issues related to pegfilgrastim biosimilar product candidate CHS-1701 are required prior to rendering a CHMP opinion. The Company anticipates such interactions will occur prior to the next CHMP meeting on July 23 to 26, 2018, which the Company understands is the next opportunity for a CHMP opinion. To date, CHMP has not requested a pre-authorization oral explanation.


SIGNATURES

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

 

Date: June 25, 2018     COHERUS BIOSCIENCES, INC.
    By:  

/s/ Jean-Frédéric Viret

    Name:   Jean-Frédéric Viret
    Title:   Chief Financial Officer