Spero Up on FDA's Feedback of Tebipenem HBr Program

 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.

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