Spero Therapeutics Shares Up 38% On FDA's Feedback of Tebipenem HBr Program
September 06 2022 - 11:45AM
Dow Jones News
By Kathryn Hardison
Shares of Spero Therapeutics Inc. climbed 38% to $1.01 Tuesday
following feedback from the Food and Drug Administration on its
tebipenem HBr program.
The FDA indicated that positive results from a single additional
Phase 3 clinical trial in patients with complicated urinary tract
infection, with supportive evidence of efficacy, could support
approval of tebipenem HBr, the company said.
Spero and the FDA also have agreed on the regulatory path
forward for the therapy, the company said. The groups are aligned
on key components of the proposed Phase 3 trial design, which may
be the subject of a special protocol assessment request, Spero
said.
"With this clarity, we are better positioned to advance the
program as we work to establish and nurture external partnerships
for further development," Chief Executive Ankit Mahadevia said.
Shares traded 94% lower for the year.
Write to Kathryn Hardison at kathryn.hardison@wsj.com
(END) Dow Jones Newswires
September 06, 2022 11:30 ET (15:30 GMT)
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