Current Report Filing (8-k)
04 October 2021 - 9:04PM
Edgar (US Regulatory)
0001429560
false
0001429560
2021-10-01
2021-10-01
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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):
October 1, 2021
TREVENA, INC.
(Exact name of registrant as specified in
its charter)
Delaware
(State or other jurisdiction of incorporation)
001-36193
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26-1469215
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(Commission
File No.)
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(IRS Employer
Identification No.)
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955 Chesterbrook Boulevard, Suite 110
Chesterbrook, PA 19087
(Address of principal executive offices
and zip code)
Registrant’s telephone number, including
area code: (610) 354-8840
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:
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¨
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Written communications pursuant to Rule 425 under the
Securities Act (17 CFR 230.425)
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¨
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Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12)
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¨
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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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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, $0.001 par value
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TRVN
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The Nasdaq Stock Market LLC
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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 October 1, 2021, Trevena, Inc. (the “Company”) received
verbal notification from the U.S. Food and Drug Administration (the “FDA”) that the Company's submitted Investigational New
Drug (“IND”) application for TRV045 will be placed on hold to address certain Phase 1 study design elements.
In accordance with standard practice, the FDA will issue a letter within the next 30 days documenting the items that need to be addressed.
Once the Company receives this letter, it expects to respond to the FDA quickly.
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.
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TREVENA, INC.
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Date: October 4, 2021
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By:
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/s/ Barry Shin
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Barry Shin
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Senior Vice President, Chief Financial Officer
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and Chief Compliance Officer
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