8-K: Current report filing
Published on October 4, 2021
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
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.
| TREVENA, INC. | ||
| Date: October 4, 2021 | By: | /s/ Barry Shin |
| Barry Shin | ||
| Senior Vice President, Chief Financial Officer | ||
| and Chief Compliance Officer | ||