Item 8.01. Other Events.

On June 27, 2022, Spero Therapeutics, Inc. (the "Company") issued a press release announcing that it has received a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration (the "FDA") for its New Drug Application ("NDA") seeking approval for tebipenem HBr oral tablets for treatment of adult patients with complicated urinary tract infection ("cUTI"), including pyelonephritis. In the CRL, the FDA communicated that it had completed its review of the NDA and determined that the NDA could not be approved in its present form. The FDA ultimately concluded that the Company's Phase 3 cUTI study of tebipenem HBr (ADAPT-PO) was insufficient to support approval and that additional clinical study would be required. The Company intends to promptly request a Type A meeting with the FDA, to gain further insights as to the pathway forward towards a potential regulatory approval for tebipenem HBr.

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

Item 9.01. Financial Statements and Exhibits.





(d) Exhibits.



99.1      Press Release, dated June 27, 2022

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

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