Current Report Filing (8-k)
October 04 2021 - 8:11AM
Edgar (US Regulatory)
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0001293818
2021-09-30
2021-09-30
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
_________________
FORM 8-K
_________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
September 30, 2021
Date of Report (date of earliest event reported)
_________________
OpGen, Inc.
(Exact name of Registrant as specified in its charter)
_________________
Delaware
(State or other jurisdiction of incorporation or
organization)
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001-37367
(Commission
File Number)
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06-1614015
(I.R.S. Employer
Identification Number)
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9717
Key West Ave, Suite 100
Rockville, MD
20850
(Address of principal executive offices)(Zip code)
(240) 813-1260
(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 (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))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Common Stock
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OPGN
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The Nasdaq Capital Market
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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. ☐
Item 8.01 — Other Events.
On October 4, 2021, OpGen, Inc. (the “Company”) announced that
on September 30, 2021, the Company received clearance from the U.S. Food and Drug Administration (“FDA”) of its 510(k) application
for its Acuitas AMR Gene Panel test for use with bacterial isolates. The Company’s press release is filed as Exhibit 99.1 to this
Current Report on Form 8-K.
Also, on October 4, 2021, the Company issued a press release announcing
preliminary financial results for the quarter ended September 30, 2021. The Company’s press release is filed as Exhibit 99.2
to this Current Report on Form 8-K.
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, thereunto duly authorized.
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Date: October 4, 2021
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OpGen, Inc.
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By:
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/s/ Oliver Schacht PhD
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Name:
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Oliver
Schacht PhD
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Title:
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Chief
Executive Officer
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