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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): December 19, 2022

 

 

 

ENTRADA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware 001-40969 81-3983399
(State or other jurisdiction (Commission (I.R.S. Employer
of incorporation) File Number) Identification No.)

 

6 Tide Street    
Boston, MA   02210
(Address of principal
executive offices)
  (Zip Code)

 

Registrant’s telephone number, including area code: (857) 520-9158

 

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:

 

¨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   Trading
Symbol(s)
  Name of each exchange
on which registered
Common Stock, $0.0001 par value per share   TRDA   The Nasdaq Global Market

 

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 x

 

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 8.01Other Events.

 

On December 19, 2022, Entrada Therapeutics, Inc. announced that it received a clinical hold notice from the U.S. Food and Drug Administration regarding the Investigational New Drug application for ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy. A copy of the press release is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference.

 

Item 9.01Financial Statements and Exhibits.

 

(d) Exhibits.

 

99.1Press Release issued by Entrada Therapeutics, Inc. on December 19, 2022.

 

104Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

  

 

 

SIGNATURE

 

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.

 

  Entrada Therapeutics, Inc.
   
Date: December 19, 2022 /s/ Dipal Doshi
  Dipal Doshi
  President and Chief Executive Officer