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): July 26, 2021

 

Iterum Therapeutics plc

(Exact name of registrant as specified in its charter)

Ireland

001-38503

98-1283148

(State or other jurisdiction

(Commission File Number)

(IRS Employer Identification No.)

of incorporation)

 

 

 

 

 

 

Block 2 Floor 3, Harcourt Centre,

Harcourt Street,

Dublin 2, Ireland


Not Applicable

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: +353 1 903 8920

 

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

Trading Symbol

Name of Each Exchange on Which Registered

Ordinary Shares, par value $0.01 per share

ITRM

Nasdaq Capital 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

 

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 July 26, 2021, Iterum Therapeutics plc issued a press release announcing that it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen.  The CRL provided that the FDA has completed its review of the NDA and has determined that it cannot approve the NDA in its present form.

 

The full text of the press release issued in connection with this announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

 

 

 

Exhibit No.

  

Description

 

 

99.1

 

Press Release of Iterum Therapeutics plc dated July 26, 2021

 



 

 

SIGNATURE

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.

 

 

Iterum Therapeutics plc

 

 

 

Dated: July 26, 2021

 

 

 

 

By:

/s/ Corey N. Fishman

 

 

 

 

Corey N. Fishman

 

 

 

Chief Executive Officer

 

 

 

 

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