Spero Therapeutics Inc. filed SEC Form 8-K: Regulation FD Disclosure
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| Item 7.01 | Regulation FD Disclosure |
On June 17, 2026, Spero Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) has granted approval for Utebzi (tebipenem pivoxil), an oral antibiotic for the treatment of complicated urinary tract infections (“cUTIs”), including pyelonephritis, caused by certain susceptible pathogens in adult patients who have limited or no alternative oral treatment option.
The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 7.01 by reference.
The information in this Item 7.01 and Exhibit 99.1, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section or sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 8.01 | Other Events. |
On June 17, 2026, the Company issued a press release announcing that the FDA has granted approval for Utebzi (tebipenem pivoxil), an oral antibiotic for the treatment of cUTIs, including pyelonephritis, caused by certain susceptible pathogens in adult patients who have limited or no alternative oral treatment option. This is the first and only oral carbapenem antibiotic approved for these patients. This approval is a result of GSK’s development and exclusive global licensing agreement (excluding select Asian territories) with the Company. FDA approval was received in advance of FDA-assigned Prescription Drug User Fee Act (“PDUFA”) date of June 18, 2026.
| Item 9.01 | Financial Statements and Exhibits |
| (d) | Exhibits |
| Exhibit No. | Description | |
| 99.1 | Press release issued by Spero Therapeutics, Inc. on June 17, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document and incorporated as Exhibit 101) | |
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.
| Date: June 22, 2026 | SPERO THERAPEUTICS, INC. | |||||
| By: | /s/ Esther Rajavelu | |||||
| Esther Rajavelu | ||||||
| Chief Executive Officer, Chief Financial Officer and Chief Business Officer | ||||||