Current Report Filing (8-k)
June 25 2018 - 3:30PM
Edgar (US Regulatory)
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)
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Delaware
(State or other jurisdiction
of incorporation)
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001-36721
(Commission
File Number)
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27-3615821
(IRS Employer
Identification Number)
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333 Twin Dolphin Drive, Suite 600
Redwood City, CA 94065
(Address of principal executive offices, including Zip Code)
Registrants 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:
☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17 CFR
240.14a-12)
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Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
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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. ☐
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.
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Date: June 25, 2018
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COHERUS BIOSCIENCES, INC.
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By:
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/s/
Jean-Frédéric
Viret
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Name:
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Jean-Frédéric
Viret
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Title:
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Chief Financial Officer
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