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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